Medical Recalls
Browse medical device and healthcare-related recall notices.
Tornier, inc
High PriorityActive
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
1. UDI-DI (GTIN) 00840338603623 Lot Numbers AZ0124352 AZ0224352 AZ0324352 AZ0424352 AZ0524352 2. UDI-DI (GTIN) 00840338603630 Lot Numbers AZ0624352 AZ0724352 AZ0824352 AZ0924352 AZ1024352 3. UDI-DI (GTIN) 00840338604033 Lot Numbers AZ0124351 AZ0224351 AZ0524351 AZ0724351 AZ0924351
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25IBN161; Medline SKU VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25GBF769; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, Lot Number 25HBN798; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, Lot Number 25GBL527; Medline SKU VASC1198, UDI/DI each 10193489664263, UDI/DI case 40193489664264, Lot Number 25GDA142; Medline SKU VASCSHPOFF1, UDI/DI each 10889942405503, UDI/DI case 40889942405504, Lot Number 25IBP989; Medline SKU VASCSHPOFF1, UDI/DI each 10889942405503, UDI/DI case 40889942405504, Lot Number 25GBL526; Medline SKU VASCSLPON1, UDI/DI each 10889942405510, UDI/DI case 40889942405511, Lot Number 25GBL070.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IM , UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834147, Lot Number 15834147.
Apr 15, 2026
View details →Siemens medical solutions usa, inc
High PriorityActive
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.
Apr 15, 2026
View details →Beckman coulter, inc.
High PriorityActive
MicroScan Neg MIC 3J REF C54814
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)261005(10)NS15690755, Lot Number NS15690755; Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)260426(10)NS15408335, Lot Number NS15408335.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)260509(10)15885574X, Lot Number 15885574X; Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)281203(10)15783003X, Lot Number 15783003X; Reference Part Number CMW-14-300-12G, UDI (01)00827002507913(17)260227(10)15416547, Lot Number 15416547.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU 60010027, Lot Number 25EBF689; Medline SKU 60010027, Lot Number 25CBL960; Medline SKU 60010027, Lot Number 24LBO743; Medline SKU 60010195, Lot Number 25ABI082; Medline SKU 60010195, Lot Number 24IBJ827; Medline SKU 60010195, Lot Number 24HBO437; Medline SKU 60010195, Lot Number 24DBR149; Medline SKU 60010195, Lot Number 24CBF820; Medline SKU 60011433, Lot Number 26BBJ156; Medline SKU 60011433, Lot Number 26ABH642; Medline SKU 60011433, Lot Number 25KBJ356; Medline SKU 60011433, Lot Number 25HBQ865; Medline SKU 60011433, Lot Number 25FBS131; Medline SKU 60011433, Lot Number 25DBR246; Medline SKU 60011433, Lot Number 25CBS392; Medline SKU 60011433, Lot Number 25CBB739; Medline SKU 60011433, Lot Number 24JBR628; Medline SKU 60011433, Lot Number 24EBL302; Medline SKU 60011433, Lot Number 24BBS083; Medline SKU 60011433, Lot Number 23LBH316; Medline SKU 60011433, Lot Number 23JBP386; Medline SKU 60011433, Lot Number 23HBB765; Medline SKU 60011433, Lot Number 23FBC617; Medline SKU 60011433, Lot Number 23EBD152; Medline SKU 60011433, Lot Number 23DBR429; Medline SKU 60020323, Lot Number 25LBK008; Medline SKU 60020323, Lot Number 25JBJ120; Medline SKU 60020323, Lot Number 25HBQ807; Medline SKU 60020323, Lot Number 25GBA069; Medline SKU 60020323, Lot Number 25EBC643; Medline SKU 60020323, Lot Number 25CBE212; Medline SKU 60023904, Lot Number 26BBB137; Medline SKU 60023904, Lot Number 26ABL323; Medline SKU 60023904, Lot Number 25JBM214; Medline SKU 60023904, Lot Number 25EBM357; Medline SKU 60023904, Lot Number 25DBC905; Medline SKU 60023904, Lot Number 25CBU751; Medline SKU 60023904, Lot Number 25BBL199; Medline SKU 60023904, Lot Number 25ABP367; Medline SKU 60033123, Lot Number 25LBD357; Medline SKU 60033123, Lot Number 25JBS750; Medline SKU 60033123, Lot Number 25IBF219; Medline SKU 60033123, Lot Number 25HBQ032; Medline SKU 60033123, Lot Number 25GBJ123; Medline SKU 60033123, Lot Number 25FBF145; Medline SKU 60033123, Lot Number 25BBR862; Medline SKU 60033123, Lot Number 25BBI613; Medline SKU 60035431, Lot Number 25FBJ204; Medline SKU 60035431, Lot Number 25FBJ126; Medline SKU 60035431, Lot Number 25DBR499; Medline SKU 60035431, Lot Number 25CBG499; Medline SKU 60035431, Lot Number 25BBL338; Medline SKU 60035431, Lot Number 25ABS403; Medline SKU 60035431, Lot Number 25ABJ801; Medline SKU 60040706, Lot Number 25ABR093; Medline SKU 60061801, Lot Number 26ABB719; Medline SKU 60061801, Lot Number 25LBD922; Medline SKU 60061801, Lot Number 25KBB972; Medline SKU 60061801, Lot Number 25IBQ948; Medline SKU 60061801, Lot Number 25IBG717; Medline SKU 60061801, Lot Number 25ABF762; Medline SKU 60080349, Lot Number 26ABT007; Medline SKU 60080349, Lot Number 25KBA752; Medline SKU 60080349, Lot Number 25IBF307; Medline SKU 60080349, Lot Number 25EBF843; Medline SKU 60080349, Lot Number 25CBK717; Medline SKU 60080349, Lot Number 25CBA408; Medline SKU 60080349, Lot Number 24LBN469; Medline SKU 60100029, Lot Number 26BBH341; Medline SKU 60100029, Lot Number 26ABL391; Medline SKU 60100029, Lot Number 25LBS254; Medline SKU 60100029, Lot Number 25KBG811; Medline SKU 60100029, Lot Number 25JBB101; Medline SKU 60100029, Lot Number 25HBG368; Medline SKU 60100029, Lot Number 25EBR355; Medline SKU 60100029, Lot Number 24LBO386; Medline SKU 60100029, Lot Number 24LBN875; Medline SKU 60100599, Lot Number 25DBV070; Medline SKU 60100599, Lot Number 25DBR988; Medline SKU 60100599, Lot Number 25DBC935; Medline SKU 60100599, Lot Number 25CBR993; Medline SKU 60100599, Lot Number 25BBK878; Medline SKU 60100599, Lot Number 25ABL231; Medline SKU 60100599, Lot Number 24JBK614; Medline SKU 60100599, Lot Number 24FBT353; Medline SKU 60100599, Lot Number 24CBJ893; Medline SKU 60100718, Lot Number 26ABV508; Medline SKU 60100718, Lot Number 25LBN909; Medline SKU 60100718, Lot Number 25JBY063; Medline SKU 60100718, Lot Number 25FBU152; Medline SKU 60100718, Lot Number 25FBH866; Medline SKU 60100718, Lot Number 25DBQ311; Medline SKU 60100718, Lot Number 25CBB740; Medline SKU 60100718, Lot Number 25BBL043; Medline SKU 60100718, Lot Number 24KBR054; Medline SKU 60100718, Lot Number 24IBQ373; Medline SKU 60100718, Lot Number 24EBV454; Medline SKU 60100718, Lot Number 24EBE042; Medline SKU 60100718, Lot Number 24ABI380; Medline SKU 60100718, Lot Number 23IBO420; Medline SKU 60100718, Lot Number 23HBB880; Medline SKU 60100718, Lot Number 23FBA834; Medline SKU 60100718, Lot Number 23CBC354; Medline SKU 60101591, Lot Number 25DBB111; Medline SKU 60101591, Lot Number 25CBN928; Medline SKU 60101591, Lot Number 25ABK745; Medline SKU 60122271, Lot Number 25HBL102; Medline SKU 60122271, Lot Number 25EBQ169; Medline SKU 60122271, Lot Number 25EBC251; Medline SKU 60122271, Lot Number 25CBL109; Medline SKU 60122271, Lot Number 25BBE731; Medline SKU 60122271, Lot Number 25ABV175; Medline SKU 60130506, Lot Number 25FBK959; Medline SKU 60130506, Lot Number 25FBF616; Medline SKU 60130506, Lot Number 25EBC252; Medline SKU 60130506, Lot Number 25CBU110; Medline SKU 60130506, Lot Number 25CBG643; Medline SKU 60130506, Lot Number 25BBS815; Medline SKU 60130506, Lot Number 24KBN940; Medline SKU 60130506, Lot Number 24DBK642; Medline SKU 60130506, Lot Number 24CBO038; Medline SKU 60130506, Lot Number 24CBO214; Medline SKU 60130506, Lot Number 24BBM144; Medline SKU 60130506, Lot Number 24BBG034; Medline SKU 60130506, Lot Number 24ABD855; Medline SKU 60130506, Lot Number 23LBS016; Medline SKU 60130506, Lot Number 23LBD402; Medline SKU 60130885, Lot Number 26ABC205; Medline SKU 60130885, Lot Number 25LBJ899; Medline SKU 60130885, Lot Number 25IBP858; Medline SKU 60130885, Lot Number 25HBA122; Medline SKU 60130885, Lot Number 25DBM316; Medline SKU 60130885, Lot Number 25CBT243; Medline SKU 60130885, Lot Number 25CBC920; Medline SKU 60130885, Lot Number 24LBP232; Medline SKU 60131679, Lot Number 25HBQ693; Medline SKU 60131679, Lot Number 25EBV636; Medline SKU 60131679, Lot Number 25DBR439; Medline SKU 60131679, Lot Number 25CBM672; Medline SKU 60131679, Lot Number 25ABR857; Medline SKU 60131679, Lot Number 25ABG253; Medline SKU 60132238, Lot Number 26BBL416; Medline SKU 60132238, Lot Number 26ABM807; Medline SKU 60132238, Lot Number 25KBB948; Medline SKU 60132238, Lot Number 25IBT687; Medline SKU 60132238, Lot Number 25EBE549; Medline SKU 60132238, Lot Number 25EBC051; Medline SKU 60132238, Lot Number 25CBO416; Medline SKU 60132238, Lot Number 25CBL913; Medline SKU 60132238, Lot Number 25CBI001; Medline SKU 60132238, Lot Number 25BBR314; Medline SKU 60132238, Lot Number 25ABV176; Medline SKU 60132238, Lot Number 25ABG502; Medline SKU 60132238, Lot Number 24FBM887; Medline SKU 60132238, Lot Number 24CBA189; Medline SKU 60132238, Lot Number 24BBR657; Medline SKU 60140094, Lot Number 26ABE092; Medline SKU 60140094, Lot Number 25LBK314; Medline SKU 60140094, Lot Number 25KBE944; Medline SKU 60140094, Lot Number 25IBJ438; Medline SKU 60140094, Lot Number 25HBL097; Medline SKU 60140094, Lot Number 25HBG349; Medline SKU 60140094, Lot Number 25EBM103; Medline SKU 60140094, Lot Number 25DBO010; Medline SKU 60140094, Lot Number 25BBH338; Medline SKU 60140589, Lot Number 26ABN648; Medline SKU 60140589, Lot Number 25KBJ830; Medline SKU 60140589, Lot Number 25IBM684; Medline SKU 60140589, Lot Number 25HBL092; Medline SKU 60140589, Lot Number 25FBO675; Medline SKU 60140589, Lot Number 25FBE410; Medline SKU 60140589, Lot Number 25EBB629; Medline SKU 60140589, Lot Number 25ABQ318; Medline SKU 60140589, Lot Number 24LBQ695; Medline SKU 60141021, Lot Number 26ABH496; Medline SKU 60141021, Lot Number 25JBR790; Medline SKU 60141021, Lot Number 25HBQ756; Medline SKU 60141021, Lot Number 25EBU930; Medline SKU 60141021, Lot Number 25DBB388; Medline SKU 60141021, Lot Number 24LBN855; Medline SKU 60160514, Lot Number 24IBH205; Medline SKU 60160514, Lot Number 24CBC706; Medline SKU 60160514, Lot Number 24BBH837; Medline SKU 60160878, Lot Number 25FBJ600; Medline SKU 60160878, Lot Number 25CBT066; Medline SKU 60160878, Lot Number 25CBG645; Medline SKU 60160878, Lot Number 25BBS816; Medline SKU 60160878, Lot Number 25ABR858; Medline SKU 60180156, Lot Number 26ABS453; Medline SKU 60180156, Lot Number 25LBH048; Medline SKU 60180156, Lot Number 25IBM968; Medline SKU 60180156, Lot Number 25HBQ056; Medline SKU 60180156, Lot Number 25GBX675; Medline SKU 60180156, Lot Number 25EBJ905; Medline SKU 60180156, Lot Number 25DBR438; Medline SKU 60180156, Lot Number 25BBK645; Medline SKU 60180156, Lot Number 25ABR956; Medline SKU 60180156, Lot Number 25ABJ804; Medline SKU 60180156, Lot Number 24KBD741; Medline SKU 60180156, Lot Number 24JBA237; Medline SKU 60180156, Lot Number 24HBW715; Medline SKU 60180156, Lot Number 24HBI921; Medline SKU 60180156, Lot Number 24FBO516; Medline SKU 60180156, Lot Number 24CBM435; Medline SKU 60180156, Lot Number 24ABS907; Medline SKU 60180156, Lot Number 23LBC208; Medline SKU 60180156, Lot Number 23KBE412; Medline SKU 60180156, Lot Number 23IBK501; Medline SKU 60180156, Lot Number 23GBU189; Medline SKU 60180156, Lot Number 23GBD301; Medline SKU 60180156, Lot Number 23CBL836; Medline SKU 60180156, Lot Number 23DBF894; Medline SKU 60180186, Lot Number 25EBS429; Medline SKU 60180186, Lot Number 25DBM281; Medline SKU 60180186, Lot Number 24LBN960; Medline SKU 60183136, Lot Number 26ABT001; Medline SKU 60183136, Lot Number 25IBG371; Medline SKU 60183136, Lot Number 25HBM078; Medline SKU 60183136, Lot Number 25GBX850; Medline SKU 60183136, Lot Number 25EBE015; Medline SKU 60183136, Lot Number 25CBV059; Medline SKU 60183136, Lot Number 25BBT249; Medline SKU 60183136, Lot Number 25ABK648; Medline SKU 60183293, Lot Number 25GBS510; Medline SKU 60183293, Lot Number 25FBP227; Medline SKU 60183293, Lot Number 25FBK960; Medline SKU 60183293, Lot Number 25EBP373; Medline SKU 60183293, Lot Number 25CBT119; Medline SKU 60191289, Lot Number 25JBV509; Medline SKU 60191289, Lot Number 25IBG353; Medline SKU 60191289, Lot Number 25GBJ128; Medline SKU 60191289, Lot Number 25FBF124; Medline SKU 60191289, Lot Number 25DBB981; Medline SKU 60191289, Lot Number 25ABJ137; Medline SKU 60192012, Lot Number 26BBN954; Medline SKU 60192012, Lot Number 26ABF962; Medline SKU 60192012, Lot Number 26ABC178; Medline SKU 60192012, Lot Number 25HBL094; Medline SKU 60192012, Lot Number 25GBX825; Medline SKU 60192012, Lot Number 25EBH401; Medline SKU 60192012, Lot Number 25CBQ237; Medline SKU 60192012, Lot Number 24LBT384; Medline SKU 60192012, Lot Number 24LBL633; Medline SKU 60195581, Lot Number 26BBO728; Medline SKU 60195581, Lot Number 25LBK466; Medline SKU 60195581, Lot Number 25KBF257; Medline SKU 60195581, Lot Number 25IBV439; Medline SKU 60195581, Lot Number 25EBT413; Medline SKU 60195581, Lot Number 25EBB820; Medline SKU 60195581, Lot Number 25CBE192; Medline SKU 60195581, Lot Number 24LBT495; Medline SKU 60195581, Lot Number 24LBN892; Medline SKU 60220488, Lot Number 24JBC085; Medline SKU 60220488, Lot Number 24HBS750; Medline SKU 60220488, Lot Number 24CBM350; Medline SKU 60220488, Lot Number 24CBM351; Medline SKU 60220488, Lot Number 24BBL703; Medline SKU 60220488, Lot Number 23LBD120; Medline SKU 60220488, Lot Number 23LBC520; Medline SKU 60220488, Lot Number 23LBC519; Medline SKU 60220942, Lot Number 25JBU524; Medline SKU 60220942, Lot Number 25GBJ126; Medline SKU 60220942, Lot Number 25EBS430; Medline SKU 60220942, Lot Number 25CBT191; Medline SKU 60220942, Lot Number 25BBT321; Medline SKU 60220942, Lot Number 25ABS428; Medline SKU 60220942, Lot Number 24LBT799; Medline SKU 60220942, Lot Number 24LBN924; Medline SKU 60232091, Lot Number 25IBN368; Medline SKU 65120676, Lot Number 25CBT986; Medline SKU 65120676, Lot Number 25CBG302; Medline SKU 65120676, Lot Number 25ABQ021; Medline SKU 65120676, Lot Number 25ABK611; Medline SKU 65120676, Lot Number 25ABE396; Medline SKU 65120676, Lot Number 24KBT666; Medline SKU 65120676, Lot Number 24JBW972; Medline SKU 65120676, Lot Number 24JBW074; Medline SKU 65120676, Lot Number 24JBS907; Medline SKU 65120676, Lot Number 24IBC872; Medline SKU 65120676, Lot Number 24HBL002; Medline SKU 65120676, Lot Number 24GBT173; Medline SKU 65120676, Lot Number 24GBA483; Medline SKU 65120676, Lot Number 24EBE616; Medline SKU 65120676, Lot Number 23IBD295; Medline SKU 65122653, Lot Number 25KBC156; Medline SKU 65122653, Lot Number 25HBS854; Medline SKU 65122653, Lot Number 25HBK305; Medline SKU 65122653, Lot Number 25HBA591; Medline SKU 65122653, Lot Number 25GBX425; Medline SKU 65122653, Lot Number 25EBM532; Medline SKU 65122653, Lot Number 25EBE531; Medline SKU 65122653, Lot Number 25EBF504; Medline SKU 65122653, Lot Number 25DBT301; Medline SKU 65122653, Lot Number 25DBR964; Medline SKU 65122653, Lot Number 25CBP819; Medline SKU 65122653, Lot Number 25BBH517; Medline SKU 65122653, Lot Number 24HBS337; Medline SKU 65122653, Lot Number 24HBR366; Medline SKU 65122653, Lot Number 24GBN296; Medline SKU 65122653, Lot Number 24FBC740; Medline SKU 65122653, Lot Number 24CBF011; Medline SKU 600302812, Lot Number 25LBJ993; Medline SKU 600302812, Lot Number 25KBD905; Medline SKU 600302812, Lot Number 25GBJ124; Medline SKU 600302812, Lot Number 25FBH865; Medline SKU 600302812, Lot Number 25DBO056; Medline SKU 600302812, Lot Number 25BBH315; Medline SKU 600302812, Lot Number 24IBR595; Medline SKU 600302812, Lot Number 24HBS729; Medline SKU 600302812, Lot Number 24FBS819; Medline SKU 600302812, Lot Number 24EBM492; Medline SKU 600302812, Lot Number 24DBJ499; Medline SKU 600302812, Lot Number 24ABK467; Medline SKU 600302812, Lot Number 23KBF152; Medline SKU 600302812, Lot Number 23IBM019; Medline SKU 600302812, Lot Number 23GBK056; Medline SKU 600302812, Lot Number 23EBC843; Medline SKU 600302812, Lot Number 23DBQ444; Medline SKU 600302812, Lot Number 23DBH161; Medline SKU 600303114, Lot Number 25FBF113; Medline SKU 600303114, Lot Number 25EBJ508; Medline SKU 600303114, Lot Number 25ABJ795; Medline SKU 601000120, Lot Number 26BBO797; Medline SKU 601000120, Lot Number 26ABQ004; Medline SKU 601000120, Lot Number 25KBP908; Medline SKU 601000120, Lot Number 25KBH296; Medline SKU 601000120, Lot Number 25IBG351; Medline SKU 601000120, Lot Number 25GBX833; Medline SKU 601000120, Lot Number 25FBO147; Medline SKU 601000120, Lot Number 25CBU978; Medline SKU 601000120, Lot Number 25BBL493; Medline SKU 601000120, Lot Number 25ABU972; Medline SKU 601000120, Lot Number 25ABK681; Medline SKU 601000120, Lot Number 24LBM705; Medline SKU 601006269, Lot Number 26BBO252; Medline SKU 601006269, Lot Number 26ABM374; Medline SKU 601006269, Lot Number 26ABA296; Medline SKU 601006269, Lot Number 25IBV472; Medline SKU 601006269, Lot Number 25IBF118; Medline SKU 601006269, Lot Number 25FBN589; Medline SKU 601006269, Lot Number 25EBA296; Medline SKU 601006269, Lot Number 25CBN927; Medline SKU 601006269, Lot Number 24LBB805; Medline SKU 601006269, Lot Number 24KBR053; Medline SKU 601006269, Lot Number 24KBL357; Medline SKU 601006269, Lot Number 24KBL665; Medline SKU 601006269, Lot Number 24JBX239; Medline SKU 601006269, Lot Number 24GBT409; Medline SKU 601006269, Lot Number 24GBT418; Medline SKU 601006269, Lot Number 24FBD353; Medline SKU 601006269, Lot Number 24EBH524; Medline SKU 601006269, Lot Number 24BBV062; Medline SKU 601006269, Lot Number 24BBG011; Medline SKU 601006269, Lot Number 23KBW790; Medline SKU 601100113, Lot Number 26BBO817; Medline SKU 601100113, Lot Number 25LBN913; Medline SKU 601100113, Lot Number 25JBX582; Medline SKU 601100113, Lot Number 25IBG502; Medline SKU 601100113, Lot Number 25EBQ195; Medline SKU 601100113, Lot Number 25CBK755; Medline SKU 601100113, Lot Number 25ABS424; Medline SKU 601100113, Lot Number 24LBN856; Medline SKU 601203616, Lot Number 24HBL889; Medline SKU 601313712, Lot Number 26BBJ152; Medline SKU 601313712, Lot Number 25LBB618; Medline SKU 601313712, Lot Number 25IBJ466; Medline SKU 601313712, Lot Number 25HBA085; Medline SKU 601313712, Lot Number 25EBQ213; Medline SKU 601313712, Lot Number 25CBP964; Medline SKU 601313712, Lot Number 25BBL479; Medline SKU 601313712, Lot Number 25ABS850; Medline SKU 601313712, Lot Number 25ABR960; Medline SKU 601313712, Lot Number 25ABJ136; Medline SKU 601313712, Lot Number 24IBO132; Medline SKU 601313712, Lot Number 24IBD010; Medline SKU 601313712, Lot Number 24IBD011; Medline SKU 601313712, Lot Number 24GBY815; Medline SKU 601313712, Lot Number 24CBD155; Medline SKU 601401518, Lot Number 26BBO744; Medline SKU 601401518, Lot Number 25LBD944; Medline SKU 601401518, Lot Number 25IBN839; Medline SKU 601401518, Lot Number 25IBA521; Medline SKU 601401518, Lot Number 25HBQ033; Medline SKU 601401518, Lot Number 25FBG171; Medline SKU 601401518, Lot Number 25CBU992; Medline SKU 601401518, Lot Number 25ABQ184; Medline SKU 601401518, Lot Number 24LBP233; Medline SKU 601601410, Lot Number 26BBF085; Medline SKU 601601410, Lot Number 25LBB621; Medline SKU 601601410, Lot Number 25KBC702; Medline SKU 601601410, Lot Number 25IBV467; Medline SKU 601601410, Lot Number 25IBF116; Medline SKU 601601410, Lot Number 25FBF135; Medline SKU 601601410, Lot Number 25EBE906; Medline SKU 601601410, Lot Number 25DBV072; Medline SKU 601601410, Lot Number 25DBC057; Medline SKU 601832314, Lot Number 26ABG466; Medline SKU 601832314, Lot Number 25JBS025; Medline SKU 601832314, Lot Number 25IBG331; Medline SKU 601832314, Lot Number 25HBQ009; Medline SKU 601832314, Lot Number 25GBH359; Medline SKU 601832314, Lot Number 25GBC679; Medline SKU 601832314, Lot Number 25FBO132; Medline SKU 601832314, Lot Number 25EBP347; 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Medline SKU 602500212, Lot Number 26ABU567; Medline SKU 602500212, Lot Number 25LBS260; Medline SKU 602500212, Lot Number 25HBQ048; Medline SKU 602500212, Lot Number 25EBM056; Medline SKU 602500212, Lot Number 25DBO061; Medline SKU 602500212, Lot Number 25ABV745; Medline SKU 602500212, Lot Number 24LBL632; Medline SKU 603015391, Lot Number 26BBO470; Medline SKU 603015391, Lot Number 25LBU348; Medline SKU 603015391, Lot Number 25KBU174; Medline SKU 603015391, Lot Number 25JBX877; Medline SKU 603015391, Lot Number 25JBM966; Medline SKU 603015391, Lot Number 25HBS302; Medline SKU 603015391, Lot Number 25HBF704; Medline SKU 603015391, Lot Number 25GBG357; Medline SKU 603015391, Lot Number 25EBI277; Medline SKU 603015391, Lot Number 25BBP677; Medline SKU 603015391, Lot Number 25BBP677A; Medline SKU 603015391, Lot Number 24KBG049; Medline SKU 603015391, Lot Number 24HBM186; Medline SKU 603015391, Lot Number 24GBC816; Medline SKU 603015391, Lot Number 24EBH196; Medline SKU 603015391, Lot Number 24ABM155; 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Medline SKU 656608749, Lot Number 24FBD257; Medline SKU 656608749, Lot Number 24EBO034; Medline SKU 656608749, Lot Number 24EBH534; Medline SKU 656608749, Lot Number 24CBT018; Medline SKU 656608749, Lot Number 24CBM852; Medline SKU 656608749, Lot Number 24CBI159; Medline SKU 656608749, Lot Number 24BBK268; Medline SKU 656608749, Lot Number 24ABI614; Medline SKU 656608749, Lot Number 23FBE735; Medline SKU 656608749, Lot Number 23DBM397; Medline SKU 6010108121, Lot Number 26BBF954; Medline SKU 6010108121, Lot Number 26ABV290; Medline SKU 6010108121, Lot Number 25LBG156; Medline SKU 6010108121, Lot Number 25JBK425; Medline SKU 6010108121, Lot Number 25IBI874; Medline SKU 6010108121, Lot Number 25IBF018; Medline SKU 6010108121, Lot Number 25EBT637; Medline SKU 6010108121, Lot Number 25DBO181; Medline SKU 6010108121, Lot Number 25CBC919; Medline SKU 6010108121, Lot Number 25ABP195; Medline SKU 6010108121, Lot Number 24JBS906; Medline SKU 6010108121, Lot Number 24JBD975; Medline SKU 6010108121, Lot Number 24HBS714; Medline SKU 6010108121, Lot Number 24HBM177; Medline SKU 6010108121, Lot Number 24HBC334; Medline SKU 6010108121, Lot Number 24GBO332; Medline SKU 6010108121, Lot Number 24DBU537; Medline SKU 6010108121, Lot Number 24CBI450; Medline SKU 6010108121, Lot Number 24BBD849; Medline SKU 6010108121, Lot Number 24ABA411; Medline SKU 6018624122, Lot Number 25BBI195; Medline SKU 6018624122, Lot Number 25ABR193; Medline SKU 6061011591, Lot Number 25FBK999; Medline SKU 00-399734O, Lot Number 25ABW373; Medline SKU 00-399734O, Lot Number 24LBB646; Medline SKU 00-399734O, Lot Number 24IBM492; Medline SKU 00-399734O, Lot Number 24EBC896; Medline SKU 00-500510G, Lot Number 24ELA688; Medline SKU 00-500510G, Lot Number 24DLA711; Medline SKU 00-500510G, Lot Number 24BLA035; Medline SKU 00-500510G, Lot Number 24BLA084; Medline SKU 0M-CP31796Q, Lot Number 24HBB073; Medline SKU 0M-CP31796Q, Lot Number 24EBT473; Medline SKU 0M-CP31796Q, Lot Number 24EBE332; Medline SKU 0M-CP31796Q, Lot Number 24DBF228; Medline SKU 0M-CP31796Q, Lot Number 24CBG401; Medline SKU 0M-CP31796Q, Lot Number 24ABU569; Medline SKU 0M-CP31796Q, Lot Number 23LBF360; Medline SKU 0M-CP31796Q, Lot Number 23KBI268; Medline SKU 0M-CP31796Q, Lot Number 23IBG393; Medline SKU 0M-CP31796Q, Lot Number 23GBG007; Medline SKU 0M-CP31796Q, Lot Number 23FBE308; Medline SKU 0M-CP31796R, Lot Number 25KBM622; Medline SKU 0M-CP31796R, Lot Number 25IBG195; Medline SKU 0M-CP31796R, Lot Number 25GBI991; Medline SKU 0M-CP31796R, Lot Number 25FBR308; Medline SKU 0M-CP31796R, Lot Number 25EBG991; Medline SKU 0M-CP31796R, Lot Number 25EBE486; Medline SKU 0M-CP31796R, Lot Number 25DBO783; Medline SKU 0M-CP31796R, Lot Number 25DBA963; Medline SKU 0M-CP31796R, Lot Number 25BBD758; Medline SKU 0M-CP31796R, Lot Number 24LBD361; Medline SKU 60022681B, Lot Number 26BBF629; Medline SKU 60022681B, Lot Number 25LBD366; Medline SKU 60022681B, Lot Number 25IBV424; Medline SKU 60022681B, Lot Number 25HBL267; Medline SKU 60022681B, Lot Number 25HBA355; Medline SKU 60022681B, Lot Number 25FBJ157; Medline SKU 60022681B, Lot Number 25DBM315; Medline SKU 60022681B, Lot Number 25ABS656; Medline SKU 60022681B, Lot Number 24LBB981; Medline SKU 60022681B, Lot Number 24KBR052; Medline SKU 60022681B, Lot Number 24KBL890; Medline SKU 60022681B, Lot Number 24HBW999; Medline SKU 60022681B, Lot Number 24HBK019; Medline SKU 60022681B, Lot Number 24HBJ130; Medline SKU 60022681B, Lot Number 24FBQ965; Medline SKU 60022681B, Lot Number 24FBN874; Medline SKU 60022681B, Lot Number 24BBG031; Medline SKU 60022681B, Lot Number 24ABA804; Medline SKU 60022681B, Lot Number 23LBA250; Medline SKU 601308611A, Lot Number 25FBJ052; Medline SKU 601308611A, Lot Number 25DBQ681; Medline SKU 601308611A, Lot Number 25DBE011; Medline SKU 601308611A, Lot Number 25CBF897; Medline SKU 601308611A, Lot Number 25CBF844; Medline SKU 601308611A, Lot Number 24KBL595; Medline SKU 601308611A, Lot Number 24IBL475; Medline SKU 601308611A, Lot Number 24GBW412; Medline SKU 601308611A, Lot Number 24ABM857; Medline SKU 601308611A, Lot Number 24ABL422; Medline SKU 601308611A, Lot Number 23LBL026; Medline SKU 601308611A, Lot Number 23LBG905; Medline SKU 601308611A, Lot Number 23KBW960; Medline SKU 601308611A, Lot Number 23JBW055; Medline SKU 60190776A, Lot Number 25FBF128; Medline SKU 60190776A, Lot Number 25DBS317; Medline SKU 60190776A, Lot Number 25DBM317; Medline SKU 60190776A, Lot Number 24LBU335; Medline SKU 60210307A, Lot Number 26BBH801; Medline SKU 60210307A, Lot Number 25LBH971; Medline SKU 60210307A, Lot Number 25JBI171; Medline SKU 60210307A, Lot Number 25IBN163; Medline SKU 60210307A, Lot Number 25GBA812; Medline SKU 60210307A, Lot Number 25DBV259; Medline SKU 60210307A, Lot Number 25CBT485; Medline SKU 60210307A, Lot Number 25BBM909; Medline SKU 60210307A, Lot Number 25BBK920; Medline SKU 60210307A, Lot Number 25BBL041; Medline SKU 60210307A, Lot Number 25ABT055; Medline SKU 60210307A, Lot Number 25ABD853; Medline SKU 60210307A, Lot Number 24KBN253; Medline SKU 60210307A, Lot Number 24HBB749; Medline SKU 60210307A, Lot Number 24FBR649; Medline SKU 60210307A, Lot Number 24DBL544; Medline SKU 60805108A, Lot Number 26ABW051; Medline SKU 60805108A, Lot Number 25LBK255; Medline SKU 60805108A, Lot Number 25JBC291; Medline SKU 60805108A, Lot Number 25EBH372; Medline SKU 60805108A, Lot Number 25EBE676; Medline SKU 60805108A, Lot Number 25DBM280; Medline SKU 60805108A, Lot Number 24LBN852; Medline SKU 60805108A, Lot Number 24LBN859; Medline SKU 60805108A, Lot Number 24LBO390; Medline SKU DYNJ0048560B, Lot Number 25FMJ059; Medline SKU DYNJ0150605AB, Lot Number 24GMH442; Medline SKU DYNJ0150605AB, Lot Number 24FMI431; Medline SKU DYNJ0150605AB, Lot Number 24DME848; Medline SKU DYNJ0150605AB, Lot Number 24CMI776; Medline SKU DYNJ0150605AB, Lot Number 24CMC350; Medline SKU DYNJ0150605AB, Lot Number 24AMH350; Medline SKU DYNJ0150605AB, Lot Number 23LMD117; Medline SKU DYNJ0150605AB, Lot Number 23JMH487; Medline SKU DYNJ0150605AB, Lot Number 23IME875; Medline SKU DYNJ0150605AB, Lot Number 23HMA728; Medline SKU DYNJ0150605AB, Lot Number 23GMC203; Medline SKU DYNJ0150605AB, Lot Number 23FMH552; Medline SKU DYNJ0150605AB, Lot Number 23FMC538; Medline SKU DYNJ0150605AB, Lot Number 23EMC354; Medline SKU DYNJ0150605AC, Lot Number 25KMF440; Medline SKU DYNJ0150605AC, Lot Number 25IMF204; Medline SKU DYNJ0150605AC, Lot Number 25GMI538; Medline SKU DYNJ0150605AC, Lot Number 25GME617; Medline SKU DYNJ0150605AC, Lot Number 25FMC767; Medline SKU DYNJ0150605AC, Lot Number 25CMF568; Medline SKU DYNJ0150605AC, Lot Number 24JMJ493; Medline SKU DYNJ0150605AC, Lot Number 24IMB736; Medline SKU DYNJ0161912G, Lot Number 25IDA774; Medline SKU DYNJ0161912G, Lot Number 25HDB177; Medline SKU DYNJ0161912G, Lot Number 25GDA255; Medline SKU DYNJ0161912G, Lot Number 25EDB808; Medline SKU DYNJ0161912G, Lot Number 25EDB578; Medline SKU DYNJ0161912G, Lot Number 25EDA977; Medline SKU DYNJ0161912G, Lot Number 25DDB180; Medline SKU DYNJ0161912G, Lot Number 25CDB661; Medline SKU DYNJ0161912G, Lot Number 25CDB322; Medline SKU DYNJ0161912G, Lot Number 24KDB108; Medline SKU DYNJ0161912G, Lot Number 24JDA715; Medline SKU DYNJ0161912G, Lot Number 24HDC222; Medline SKU DYNJ0161912G, Lot Number 24GDB191; Medline SKU DYNJ0161912G, Lot Number 24EDB499; Medline SKU DYNJ0161912G, Lot Number 24EDA166; Medline SKU DYNJ0161912G, Lot Number 24CDB064; Medline SKU DYNJ0161912G, Lot Number 23LDC047; Medline SKU DYNJ0161912G, Lot Number 23KDB964; Medline SKU DYNJ0161912G, Lot Number 23JDA951; Medline SKU DYNJ0161912G, Lot Number 23IDA091; Medline SKU DYNJ0161912G, Lot Number 23GDC221; Medline SKU DYNJ0161912G, Lot Number 23FDB532; Medline SKU DYNJ0161912G, Lot Number 23EDA549; Medline SKU DYNJ0330910AB, Lot Number 24LMD027; Medline SKU DYNJ0376288O, Lot Number 25KMH462; Medline SKU DYNJ0376288O, Lot Number 25IMJ033; Medline SKU DYNJ0376288O, Lot Number 25HMA941; Medline SKU DYNJ0376288O, Lot Number 25GMH129; Medline SKU DYNJ0376288O, Lot Number 25CMH544; Medline SKU DYNJ0376288O, Lot Number 25BMF926; Medline SKU DYNJ0376288O, Lot Number 25BME027; Medline SKU DYNJ0376288O, Lot Number 25AMG187; Medline SKU DYNJ0376288O, Lot Number 24KMB099; Medline SKU DYNJ0376288O, Lot Number 24JMB965; Medline SKU DYNJ0376288O, Lot Number 24HMJ763; Medline SKU DYNJ0376288O, Lot Number 24GMG910; Medline SKU DYNJ0376288O, Lot Number 24EMF179; Medline SKU DYNJ0376288O, Lot Number 24CMI112; Medline SKU DYNJ0376288O, Lot Number 24CMF949; Medline SKU DYNJ0376288P, Lot Number 26BMC186; Medline SKU DYNJ0378596M, Lot Number 25KBI090; Medline SKU DYNJ0378596M, Lot Number 25IBD182; Medline SKU DYNJ0378596M, Lot Number 25IBD235; Medline SKU DYNJ04429Q, Lot Number 25IMB369; Medline SKU DYNJ04429Q, Lot Number 25HMA942; Medline SKU DYNJ04429Q, Lot Number 25CMH398; Medline SKU DYNJ04429Q, Lot Number 25BMG503; Medline SKU DYNJ04429Q, Lot Number 25BME030; Medline SKU DYNJ04429Q, Lot Number 25BMA094; Medline SKU DYNJ04429Q, Lot Number 24KMH345; Medline SKU DYNJ04429R, Lot Number 26BME846; Medline SKU DYNJ04429R, Lot Number 26AMB968; Medline SKU DYNJ04429R, Lot Number 25LMA580; Medline SKU DYNJ04429R, Lot Number 25JMF064; Medline SKU DYNJ0451426N, Lot Number 24DBQ934; Medline SKU DYNJ0451426N, Lot Number 24DBC244; Medline SKU DYNJ0451426N, Lot Number 24BBN311; Medline SKU DYNJ0451426N, Lot Numbe
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997; Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539; Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008; Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765; Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260424(10)15569919, Lot Number 15569919; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260403(10)15520378, Lot Number 15520378; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15487727, Lot Number 15487727; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15484947, Lot Number 15484947; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)16617145, Lot Number 16617145; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617419, Lot Number NS16617419; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617420, Lot Number NS16617420; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620091, Lot Number NS16620091; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620092, Lot Number NS16620092; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620093, Lot Number NS16620093; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620094, Lot Number NS16620094; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620414, Lot Number NS16620414; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620415, Lot Number NS16620415; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620416, Lot Number NS16620416; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622160, Lot Number NS16622160; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622161, Lot Number NS16622161; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622162, Lot Number NS16622162; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622163, Lot Number NS16622163; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622164, Lot Number NS16622164; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622165, Lot Number NS16622165; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622166, Lot Number NS16622166; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622167, Lot Number NS16622167; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622168, Lot Number NS16622168; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280602(10)NS16625835, Lot Number NS16625835; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260619(10)NS15668028, Lot Number NS15668028; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260227(10)NS15473245, Lot Number NS15473245; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282739, Lot Number NS15282739; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282763, Lot Number NS15282763; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15583873, Lot Number NS15583873; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)280714(10)NS16692824, Lot Number NS16692824; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15557442, Lot Number 15557442; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15520367, Lot Number 15520367; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260220(10)15518160, Lot Number 15518160; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260327(10)15594051, Lot Number 15594051; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280426(10)16576182, Lot Number 16576182; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280527(10)16617146, Lot Number 16617146; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280529(10)16622169, Lot Number 16622169; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280612(10)16642446, Lot Number 16642446; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260327(10)NS15583886, Lot Number NS15583886; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260314(10)NS15501647, Lot Number NS15501647; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260220(10)NS15514024, Lot Number NS15514024; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)280331(10)NS16534729, Lot Number NS16534729; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, UDI (01)00827002439856(17)280423(10)16572552, Lot Number 16572552; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280311(10)16505314, Lot Number 16505314; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280412(10)16554636, Lot Number 16554636; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280416(10)16559432, Lot Number 16559432; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280423(10)16572551, Lot Number 16572551; Reference Part Number C-UDLM-501J-PED-ABRM-HC, UDI (01)00827002439962(17)260619(10)NS15582078, Lot Number NS15582078; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, UDI (01)00827002439979(17)280428(10)NS16577963, Lot Number NS16577963; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454754, Lot Number NS16454754; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454756, Lot Number NS16454756; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280505(10)NS16587983, Lot Number NS16587983; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280521(10)NS16612427, Lot Number NS16612427; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280528(10)NS16620419, Lot Number NS16620419; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280623(10)NS16657119, Lot Number NS16657119; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, UDI (01)00827002515376(17)260417(10)15478180, Lot Number 15478180; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, UDI (01)00827002515390(17)280402(10)16539971, Lot Number 16539971; Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260626(10)15628883, Lot Number 15628883; Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260130(10)15496521, Lot Number 15496521; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15660282, Lot Number NS15660282; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15628880, Lot Number NS15628880; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)280505(10)NS16588033, Lot Number NS16588033; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280402(10)16539976, Lot Number 16539976; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280416(10)NS16493943XX, Lot Number NS16493943XX; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260710(10)NS15643882, Lot Number NS15643882; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260626(10)NS15683399, Lot Number NS15683399; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15559871, Lot Number NS15559871; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15597521, Lot Number NS15597521; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260213(10)NS15489151, Lot Number NS15489151; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280303(10)NS16490614, Lot Number NS16490614; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280304(10)NS16493940, Lot Number NS16493940; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280417(10)NS16562685, Lot Number NS16562685; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, UDI (01)00827002440074(17)260327(10)15484937, Lot Number 15484937; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, UDI (01)00827002247659(17)280328(10)NS16532973, Lot Number NS16532973; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15550737, Lot Number 15550737; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15553839, Lot Number 15553839; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15565537, Lot Number 15565537; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260327(10)15520384, Lot Number 15520384; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260713(10)15655329, Lot Number 15655329; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280318(10)16514973, Lot Number 16514973; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280331(10)16535286, Lot Number 16535286; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280411(10)16554189, Lot Number 16554189; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280414(10)16556349, Lot Number 16556349; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280430(10)16580721, Lot Number 16580721; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280502(10)16584953, Lot Number 16584953; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280602(10)16625683, Lot Number 16625683; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280602(10)16625826, Lot Number 16625826; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280606(10)16634342, Lot Number 16634342; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280609(10)16636211, Lot Number 16636211; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280609(10)16636220, Lot Number 16636220; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280611(10)16639240, Lot Number 16639240; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280318(10)16514972, Lot Number 16514972; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280328(10)16532975, Lot Number 16532975; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280412(10)16554638, Lot Number 16554638; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280417(10)16562523, Lot Number 16562523; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280429(10)16579251, Lot Number 16579251; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, UDI (01)00827002535992(17)260410(10)15518162, Lot Number 15518162; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, UDI (01)00827002535992(17)260822(10)15586027, Lot Number 15586027; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, UDI (01)00827002478275(17)280401(10)NS16537254, Lot Number NS16537254; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, UDI (01)00827002478275(17)280501(10)NS16582898, Lot Number NS16582898; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15660266, Lot Number 15660266; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15655331, Lot Number 15655331; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15683408, Lot Number 15683408; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280414(10)16556179, Lot Number 16556179; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280414(10)16556350, Lot Number 16556350; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280602(10)16625673, Lot Number 16625673; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280602(10)16625817, Lot Number 16625817; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678414, Lot Number 16678414; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678420, Lot Number 16678420; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678428, Lot Number 16678428; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280708(10)16683763, Lot Number 16683763; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280708(10)16683788, Lot Number 16683788; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)260403(10)15687199, Lot Number 15687199; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280412(10)16554639, Lot Number 16554639; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280415(10)16557470, Lot Number 16557470; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280602(10)16625682, Lot Number 16625682; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280612(10)16642011, Lot Number 16642011.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline Kit SKU # DYNJ86596, UDI/DI each 10195327656119, UDI/DI case 40195327656110, Lot Numbers: 24FMI029, 24DMK138.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270812(10)NS16200246, Lot Number NS16200246; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189601, Lot Number NS16189601; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270827(10)NS16226797, Lot Number NS16226797; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270812(10)NS16200247, Lot Number NS16200247; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189598, Lot Number NS16189598; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189586, Lot Number NS16189586; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189600, Lot Number NS16189600; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270620(10)16120672, Lot Number 16120672; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189607, Lot Number NS16189607; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189604, Lot Number 16189604; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189588, Lot Number 16189588; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189603, Lot Number 16189603; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189608, Lot Number 16189608; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189589, Lot Number 16189589; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189602, Lot Number 16189602; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270620(10)16120666, Lot Number 16120666; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189594, Lot Number 16189594.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK, Medline SKU # DYNJ84472
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # DYNJ84472, UDI/DI each 10195327369286, UDI/DI case 40195327369287, Lot Numbers: 23LBN016, 23KBL255, 23HBL885, 23FBV799.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH LFT HRT KIT, Medline SKU # 60010508; 2. MTS 3V W/GUIDE, Medline SKU # 60100701; 3. ANGIOGRAPHY KIT, Medline SKU # 60131209; 4. MTS LHK, Medline SKU # 60160075; 5. MTS LHK, Medline SKU # 60161954; 6. MTO LHK, Medline SKU # 60230148; 7. GENERAL SURGERY TRAY, Medline SKU # 00-500510I; 8. BIOBURDEN TEST KIT - 686, Medline SKU # BIOB686; 9. RADIO ANGIO UNIV HOSP PACK-LF, Medline SKU # DYNJ0376145M; 10. SPECIALS PACK-LF, Medline SKU # DYNJ0392706K; 11. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426O; 12. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426P; 13. CARDIAC CATH PACK, Medline SKU # DYNJ07953N; 14. CATH PACK-LF, Medline SKU # DYNJ0803367J; 15. E.P. TRAY, Medline SKU # DYNJ19343J; 16. CARDIAC CATH PACK, Medline SKU # DYNJ20898T; 17. CATH LAB TRAY, Medline SKU # DYNJ24250G; 18. CATH LAB PACK-LF, Medline SKU # DYNJ38333D; 19. CATH LAB PACK-LF, Medline SKU # DYNJ38333F; 20. EP IMPLANT PACK-LF, Medline SKU # DYNJ38910D; 21. ADULT CATH LAB PACK, Medline SKU # DYNJ40380J; 22. CRANIOTOMY PACK-LF, Medline SKU # DYNJ43403D; 23. LAP CHOLE PACK, Medline SKU # DYNJ48487F; 24. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779G; 25. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779I; 26. HYBRID, Medline SKU # DYNJ57049N; 27. SPECIALS PK, Medline SKU # DYNJ57713C; 28. SPECIALS PK, Medline SKU # DYNJ57713D; 29. SPECIALS PK, Medline SKU # DYNJ57713F; 30. CARDIAC CATH LAB, Medline SKU # DYNJ57748A; 31. TAVR PACK, Medline SKU # DYNJ58771G; 32. CATH PACK GWV, Medline SKU # DYNJ59229F; 33. HEART CATH PACK, Medline SKU # DYNJ61294F; 34. CATH LAB PACK, Medline SKU # DYNJ61353C; 35. DEVICE IMPLANT PACK, Medline SKU # DYNJ64636A; 36. CUSTOM PROCEDURE KIT, Medline SKU # DYNJ65277A; 37. GENERAL VASCULAR PACK RFID-V2, Medline SKU # DYNJ66442F; 38. CARDIAC CATH PACK, Medline SKU # DYNJ69845C; 39. OMF MINOR PACK, Medline SKU # DYNJ83991C; 40. HEART CATH PACK, Medline SKU # DYNJ84133B; 41. SPECIAL PROCEDURES, Medline SKU # DYNJ85425B; 42. PRIMARY PACK, Medline SKU # DYNJT3093; 43. CARDIAC CATH PACK, Medline SKU # DYNJT3522A; 44. CARDIAC CATH PACK, Medline SKU # DYNJT3522B; 45. TOTAL KNEE PACK, Medline SKU # DYNJT4069; 46. CARDIAC CATH PACK, Medline SKU # DYNJT5685; 47. CATH PACK, Medline SKU # DYNJT6544; 48. PACK CARDIAC CATH, Medline SKU # DYNJT7591; 49. OBL CATH VEIN PACK, Medline SKU # DYNJT7863; 50. TUMESCENT SYRINGE KIT, Medline SKU # DYNJTUMSYR; 51. CSTM LH KIT, Medline SKU # VASC1054; 52. LHK, Medline SKU # VASC1130A; 53. MANIFOLD KIT, Medline SKU # VASC1137A; 54. LHK, Medline SKU # VASC1299A; 55. LHK, Medline SKU # VASC1399B; 56. LHK, Medline SKU # VASC1403; 57. IR 2 PORT, Medline SKU # VASC1404; 58. LHK, Medline SKU # VASC1405; 59. LHK, Medline SKU # VASC1455A; 60. TWO PORT MANIFOLD KIT, Medline SKU # VASC1496; 61. RHK, US, NAMIC MANIFOLD, Medline SKU # VASC1502; 62. LHK, Medline SKU # VASC1555; 63. 4 VALVE,PERC,MANIFOLD,KIT, Medline SKU # VASC1609; 64. LHK, Medline SKU # VASC1668; 65. LHK, Medline SKU # VASC1694; 66. LHK, Medline SKU # VASC1805; 67. TVR, Medline SKU # VASC1816.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26BBI625; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26ABB718; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25JBJ140; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25HBF702; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23FBO996; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23FBA259; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23EBD151; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24IBE239; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24HBR112; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24GBY032; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24BBO470; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24ABB436; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23LBA225; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23GBK257; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23FBG433; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23FBC618; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23EBX036; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23DBD220; Medline SKU # 60131209, UDI/DI each 10193489046779, UDI/DI case 40193489046770, Lot Number: 24HBJ211; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24EBQ349; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24CBD613; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24ABL640; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23KBB857; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23IBC156; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23FBJ161; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23FBC907; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 26ABD974; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 25JBM213; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 25FBK284; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 25FBK967; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24KBN942; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24JBC074; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24HBQ995; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24GBP001; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24CBF239; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24ABJ769; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 23LBP098; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 23HBB863; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 23GBQ587; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 23FBG492; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 23CBR482; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 25CBJ809; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 25BBS609; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 25BBL037; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 24KBI829; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 24JBX172; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 24IBO369; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 24EBI926; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 24DBV041; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 24ABB294; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 23KBT232; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 23KBA553; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 23IBD723; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 23HBV742; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 23HBU186; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 23GBA723; Medline SKU # 60230148, UDI/DI each 10193489052985, UDI/DI case 40193489052986, Lot Number: 23DBF014; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 26BLA621; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25LLA491; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25JLA720; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25JLA241; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25HLB071; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25GLA678; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25ELA960; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25ELA670; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25DLA414; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25BLA539; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 25ALA504; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 24JLA106; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 24JLA071; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 24ILA631; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 24HLA635; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 24HLA514; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 24GLA105; Medline SKU # 00-500510I, UDI/DI each 10195327695361, UDI/DI case 40195327695362, Lot Number: 24FLA889; Medline SKU # BIOB686, UDI/DI each 10193489684025, UDI/DI case 40193489684026, Lot Number: 25IMF801; Medline SKU # BIOB686, UDI/DI each 10193489684025, UDI/DI case 40193489684026, Lot Number: 24FMH284; Medline SKU # DYNJ0376145M, UDI/DI each 10889942941643, UDI/DI case 40889942941644, Lot Number: 24ILA248; Medline SKU # DYNJ0392706K, UDI/DI each 10195327588212, UDI/DI case 40195327588213, Lot Number: 25LBP577; Medline SKU # DYNJ0392706K, UDI/DI each 10195327588212, UDI/DI case 40195327588213, Lot Number: 25IBR953; Medline SKU # DYNJ0451426O, UDI/DI each 10195327698690, UDI/DI case 40195327698691, Lot Number: 25FBF110; Medline SKU # DYNJ0451426O, UDI/DI each 10195327698690, UDI/DI case 40195327698691, Lot Number: 25EBI930; Medline SKU # DYNJ0451426O, UDI/DI each 10195327698690, UDI/DI case 40195327698691, Lot Number: 25DBE958; Medline SKU # DYNJ0451426O, UDI/DI each 10195327698690, UDI/DI case 40195327698691, Lot Number: 24JBN523; Medline SKU # DYNJ0451426O, UDI/DI each 10195327698690, UDI/DI case 40195327698691, Lot Number: 24IBC823; Medline SKU # DYNJ0451426P, UDI/DI each 10198459386336, UDI/DI case 40198459386337, Lot Number: 26BBK812; Medline SKU # DYNJ0451426P, UDI/DI each 10198459386336, UDI/DI case 40198459386337, Lot Number: 26ABI992; Medline SKU # DYNJ0451426P, UDI/DI each 10198459386336, UDI/DI case 40198459386337, Lot Number: 26ABJ025; Medline SKU # DYNJ0451426P, UDI/DI each 10198459386336, UDI/DI case 40198459386337, Lot Number: 25KBD666; Medline SKU # DYNJ0451426P, UDI/DI each 10198459386336, UDI/DI case 40198459386337, Lot Number: 25JBR728; Medline SKU # DYNJ0451426P, UDI/DI each 10198459386336, UDI/DI case 40198459386337, Lot Number: 25JBR851; Medline SKU # DYNJ0451426P, UDI/DI each 10198459386336, UDI/DI case 40198459386337, Lot Number: 25GBS862; Medline SKU # DYNJ07953N, UDI/DI each 10198459123412, UDI/DI case 40198459123413, Lot Number: 25IBK486; Medline SKU # DYNJ07953N, UDI/DI each 10198459123412, UDI/DI case 40198459123413, Lot Number: 25IBF054; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 25KBI063; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 25IBK151; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 25EBD486; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 25DBL885; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 25CBL230; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24LBG685; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24KBO528; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24JBH940; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24HBQ365; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24HBJ343; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24GBE178; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24FBN018; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24EBR279; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24CBP560; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 24ABP475; Medline SKU # DYNJ0803367J, UDI/DI each 10195327542276, UDI/DI case 40195327542277, Lot Number: 23LBS358; Medline SKU # DYNJ19343J, UDI/DI each 10888277827981, UDI/DI case 40888277827982, Lot Number: 24KBL564; Medline SKU # DYNJ20898T, UDI/DI each 10198459477003, UDI/DI case 40198459477004, Lot Number: 25KMH265; Medline SKU # DYNJ20898T, UDI/DI each 10198459477003, UDI/DI case 40198459477004, Lot Number: 25JML139; Medline SKU # DYNJ24250G, UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC371; Medline SKU # DYNJ24250G, UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC433; Medline SKU # DYNJ24250G, UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25KBH544; Medline SKU # DYNJ24250G, UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25JBG417; Medline SKU # DYNJ24250G, UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBQ931; Medline SKU # DYNJ24250G, UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBI702; Medline SKU # DYNJ38333D, UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 25AMG765; Medline SKU # DYNJ38333D, UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24KMJ018; Medline SKU # DYNJ38333D, UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24JME459; Medline SKU # DYNJ38333D, UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24HMB740; Medline SKU # DYNJ38333D, UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24GMH056; Medline SKU # DYNJ38333F, UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25KME742; Medline SKU # DYNJ38333F, UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25HME818; Medline SKU # DYNJ38333F, UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25EMB706; Medline SKU # DYNJ38333F, UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25CME621; Medline SKU # DYNJ38910D, UDI/DI each 10198459319815, UDI/DI case 40198459319816, Lot Number: 25GBJ993; Medline SKU # DYNJ38910D, UDI/DI each 10198459319815, UDI/DI case 40198459319816, Lot Number: 25EBD960; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 26ABR937; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25KBI764; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25JBR971; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25IBM264; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25IBI796; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25IBD184; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25FBV148; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25FBR538; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25FBB566; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25EBN741; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25EBF462; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25DBK395; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25CBU744; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25CBJ971; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25CBH568; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 25ABK344; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24KBG845; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24IBM450; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24IBH804; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24HBL014; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24GBU989; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24EBQ673; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24EBO710; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24DBQ947; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24CBH211; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24BBE538; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24ABU829; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 24ABA618; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 23KBO467; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 23IBS704; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 23IBM775; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 23HBX517; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 23GBO122; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 23FBW049; Medline SKU # DYNJ40380J, UDI/DI each 10193489201697, UDI/DI case 40193489201698, Lot Number: 23EBG231; Medline SKU # DYNJ43403D, UDI/DI each 10195327179236, UDI/DI case 40195327179237, Lot Number: 23FLA639; Medline SKU # DYNJ48487F, UDI/DI each 10198459572937, UDI/DI case 40198459572938, Lot Number: 26AMA021; Medline SKU # DYNJ50779G, UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25DMH709; Medline SKU # DYNJ50779G, UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25CMI786; Medline SKU # DYNJ50779G, UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25BMF563; Medline SKU # DYNJ50779G, UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 25BMC031; Medline SKU # DYNJ50779G, UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24KMC197; Medline SKU # DYNJ50779G, UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24IMI472; Medline SKU # DYNJ50779G, UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24HMA312; Medline SKU # DYNJ50779G, UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24GMA788; Medline SKU # DYNJ50779G, UDI/DI each 10195327686499, UDI/DI case 40195327686490, Lot Number: 24EMG321; Medline SKU # DYNJ50779I, UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25LMC853; Medline SKU # DYNJ50779I, UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25KMB250; Medline SKU # DYNJ50779I, UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25IME495; Medline SKU # DYNJ50779I, UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25HME177; Medline SKU # DYNJ50779I, UDI/DI each 10198459423758, UDI/DI case 40198459423759, Lot Number: 25GMF741; Medline SKU # DYNJ57049N, UDI/DI each 10198459519994, UDI/DI case 40198459519995, Lot Number: 25IMH467; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 24GBV109; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 24GBK784; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 24EBR407; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 24DBR592; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 24CBJ904; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 24ABS845; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 23KBR978; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 23JBX436; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 23IBJ923; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 23HBV971; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 23GBV284; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 23FBK372; Medline SKU # DYNJ57713C, UDI/DI each 10195327357498, UDI/DI case 40195327357499, Lot Number: 23DBO863; Medline SKU # DYNJ57713D, UDI/DI each 10198459106583, UDI/DI case 40198459106584, Lot Number: 25DBT278; Medline SKU # DYNJ57713D, UDI/DI each 10198459106583, UDI/DI case 40198459106584, Lot Number: 25CBD829; Medline SKU # DYNJ57713D, UDI/DI each 10198459106583, UDI/DI case 40198459106584, Lot Number: 25BBU169; Medline SKU # DYNJ57713D, UDI/DI each 10198459106583, UDI/DI case 40198459106584, Lot Number: 25ABB803; Medline SKU # DYNJ57713D, UDI/DI each 10198459106583, UDI/DI case 40198459106584, Lot Number: 24KBS852; Medline SKU # DYNJ57713D, UDI/DI each 10198459106583, UDI/DI case 40198459106584, Lot Number: 24IBP601; Medline SKU # DYNJ57713D, UDI/DI each 10198459106583, UDI/DI case 40198459106584, Lot Number: 24IBA400; Medline SKU # DYNJ57713F, UDI/DI each 10198459380761, UDI/DI case 40198459380762, Lot Number: 26ABU685; Medline SKU # DYNJ57713F, UDI/DI each 10198459380761, UDI/DI case 40198459380762, Lot Number: 26ABS702; Medline SKU # DYNJ57713F, UDI/DI each 10198459380761, UDI/DI case 40198459380762, Lot Number: 25KBM524; Medline SKU # DYNJ57713F, UDI/DI each 10198459380761, UDI/DI case 40198459380762, Lot Number: 25JBD873; Medline SKU # DYNJ57713F, UDI/DI each 10198459380761, UDI/DI case 40198459380762, Lot Number: 25IBR638; Medline SKU # DYNJ57713F, UDI/DI each 10198459380761, UDI/DI case 40198459380762, Lot Number: 25IBB474; Medline SKU # DYNJ57713F, UDI/DI each 10198459380761, UDI/DI case 40198459380762, Lot Number: 25FBQ397; Medline SKU # DYNJ57748A, UDI/DI each 10888277746015, UDI/DI case 40888277746016, Lot Number: 24JME277; Medline SKU # DYNJ57748A, UDI/DI each 10888277746015, UDI/DI case 40888277746016, Lot Number: 24FMA227; Medline SKU # DYNJ57748A, UDI/DI each 10888277746015, UDI/DI case 40888277746016, Lot Number: 24EMG444; Medline SKU # DYNJ58771G, UDI/DI each 10195327663308, UDI/DI case 40195327663309, Lot Number: 25ALB024; Medline SKU # DYNJ58771G, UDI/DI each 10195327663308, UDI/DI case 40195327663309, Lot Number: 24KLA767; Medline SKU # DYNJ58771G, UDI/DI each 10195327663308, UDI/DI case 40195327663309, Lot Number: 24JLA065; Medline SKU # DYNJ58771G, UDI/DI each 10195327663308, UDI/DI case 40195327663309, Lot Number: 24ILA329; Medline SKU # DYNJ58771G, UDI/DI each 10195327663308, UDI/DI case 40195327663309, Lot Number: 24HLA502; Medline SKU # DYNJ58771G, UDI/DI each 10195327663308, UDI/DI case 40195327663309, Lot Number: 24FLA645; Medline SKU # DYNJ58771G, UDI/DI each 10195327663308, UDI/DI case 40195327663309, Lot Number: 24ELA005; Medline SKU # DYNJ58771G, UDI/DI each 10195327663308, UDI/DI case 40195327663309, Lot Number: 24DLA522; Medline SKU # DYNJ58771G, UDI/DI each 10195327663308, UDI/DI case 40195327663309, Lot Number: 24DLA423; Medline SKU # DYNJ59229F, UDI/DI each 10198459483936, UDI/DI case 40198459483937, Lot Number: 26BLA718; Medline SKU # DYNJ59229F, UDI/DI each 10198459483936, UDI/DI case 40198459483937, Lot Number: 25LLA775; Medline SKU # DYNJ59229F, UDI/DI each 10198459483936, UDI/DI case 40198459483937, Lot Number: 25ILA548; Medline SKU # DYNJ59229F, UDI/DI each 10198459483936, UDI/DI case 40198459483937, Lot Number: 25ILA434; Medline SKU # DYNJ59229F, UDI/DI each 10198459483936, UDI/DI case 40198459483937, Lot Number: 25ILA036; Medline SKU # DYNJ59229F, UDI/DI each 10198459483936, UDI/DI case 40198459483937, Lot Number: 25HLA821; Medline SKU # DYNJ61294F, UDI/DI each 10195327691158, UDI/DI case 40195327691159, Lot Number: 25HBP380; Medline SKU # DYNJ61353C, UDI/DI each 10198459503054, UDI/DI case 40198459503055, Lot Number: 25LMG882; Medline SKU # DYNJ61353C, UDI/DI each 10198459503054, UDI/DI case 40198459503055, Lot Number: 25KMB331; Medline SKU # DYNJ61353C, UDI/DI each 10198459503054, UDI/DI case 40198459503055, Lot Number: 25JMK949; Medline SKU # DYNJ64636A, UDI/DI each 10195327374617, UDI/DI case 40195327374618, Lot Number: 25FBE213; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 26ABC312; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 25LBG126; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 25IBS553; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 25IBN181; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 25GBT426; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 25FBP518; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 25BBR414; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 24KBO515; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 24JBT061; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 24GBY011; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 24EBS347; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 24EBS501; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 24CBS901; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 24BBD609; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 24BBD609A; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 23KBJ915; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 23JBH747; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 23HBF936; Medline SKU # DYNJ65277A, UDI/DI each 10193489409536, UDI/DI case 40193489409537, Lot Number: 23GBA827; Medline SKU # DYNJ66442F, UDI/DI each 10198459334061, UDI/DI case 40198459334062, Lot Number: 25DBO052A; Medline SKU # DYNJ69845C, UDI/DI each 10198459657467, UDI/DI case 40198459657468, Lot Number: 26ABV680; Medline SKU # DYNJ83991C, UDI/DI each 10198459629945, UDI/DI case 40198459629946, Lot Number: 26AMF581; Medline SKU # DYNJ84133B, UDI/DI each 10198459501777, UDI/DI case 40198459501778, Lot Number: 25KBB504; Medline SKU # DYNJ85425B, UDI/DI each 10198459305566, UDI/DI case 40198459305567, Lot Number: 26BMH078; Medline SKU # DYNJ85425B, UDI/DI each 10198459305566, UDI/DI case 40198459305567, Lot Number: 25LMH057; Medline SKU # DYNJ85425B, UDI/DI each 10198459305566, UDI/DI case 40198459305567, Lot Number: 25JMD619; Medline SKU # DYNJ85425B, UDI/DI each 10198459305566, UDI/DI case 40198459305567, Lot Number: 25IMH487; Medline SKU # DYNJ85425B, UDI/DI each 10198459305566, UDI/DI case 40198459305567, Lot Number: 25IMD325; Medline SKU # DYNJ85425B, UDI/DI each 10198459305566, UDI/DI case 40198459305567, Lot Number: 25FMJ567; Medline SKU # DYNJ85425B, UDI/DI each 10198459305566, UDI/DI case 40198459305567, Lot Number: 25FMH927; Medline SKU # DYNJT3093, UDI/DI each 10198459305801, UDI/DI case 40198459305802, Lot Number: 25EBB099; Medline SKU # DYNJT3522A, UDI/DI each 10198459540479, UDI/DI case 40198459540470, Lot Number: 25JMI340; Medline SKU # DYNJT3522B, UDI/DI each 10198459602825, UDI/DI case 40198459602826, Lot Number: 25LMJ747; Medline SKU # DYNJT3522B, UDI/DI each 10198459602825, UDI/DI case 40198459602826, Lot Number: 25KME591; Medline SKU # DYNJT4069, UDI/DI each 10198459394751, UDI/DI case 40198459394752, Lot Number: 25JMI514; Medline SKU # DYNJT4069, UDI/DI each 10198459394751, UDI/DI case 40198459394752, Lot Number: 25GMB597; Medline SKU # DYNJT5685, UDI/DI each 10198459514098, UDI/DI case 40198459514099, Lot Number: 25JLA132; Medline SKU # DYNJT6544, UDI/DI each 10198459558689, UDI/DI case 40198459558680, Lot Number: 25KMF858; Medline SKU # DYNJT7591, UDI/DI each 10198459635823, UDI/DI case 40198459635824, Lot Number: 26AMH405; Medline SKU # DYNJT7863, UDI/DI each 10198459654831, UDI/DI case 40198459654832, Lot Number: 26ABT695; Medline SKU # DYNJTUMSYR, UDI/DI each 10884389882054, UDI/DI case 40884389882055, Lot Number: 26BBF460; Medline SKU # DYNJTUMSYR, UDI/DI each 10884389882054, UDI/DI case 40884389882055, Lot Number: 26ABT525; Medline SKU # DYNJTUMSYR, UDI/DI each 10884389882054, UDI/DI case 40884389882055, Lot Number: 25LBP400; Medline SKU # DYNJTUMSYR, UDI/DI each 10884389882054, UDI/DI case 40884389882055, Lot Number: 25LBK861; Medline SKU # DYNJTUMSYR, UDI/DI each 10884389882054, UDI/DI case 40884389882055, Lot Number: 25LBK862; Medline SKU # VASC1054, UDI/DI each 10889942379217, UDI/DI case 40889942379218, Lot Number: 25GBM922; Medline SKU # VASC1054, UDI/DI each 10889942379217, UDI/DI case 40889942379218, Lot Number: 25FBV097; Medline SKU # VASC1130A, UDI/DI each 10198459040092, UDI/DI case 40198459040093, Lot Number: 25HBE924; Medline SKU # VASC1137A, UDI/DI each 10195327636692, UDI/DI case 40195327636693, Lot Number: 25HBU244; Medline SKU # VASC1299A, UDI/DI each 10195327076450, UDI/DI case 40195327076451, Lot Number: 25FBQ566; Medline SKU # VASC1299A, UDI/DI each 10195327076450, UDI/DI case 40195327076451, Lot Number: 25FBH292; Medline SKU # VASC1299A, UDI/DI each 10195327076450, UDI/DI case 40195327076451, Lot Number: 24HBE146; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 26ABT499; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 25LBD803; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 25IBN891; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 25GBM607; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 25FBI750; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 25EBQ507; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 25DBT209; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 25BBS353; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 24KBQ595; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 24HBX234; Medline SKU # VASC1399B, UDI/DI each 10198459001802, UDI/DI case 40198459001803, Lot Number: 24EBT407; Medline SKU # VASC1403, UDI/DI each 10195327366285, UDI/DI case 40195327366286, Lot Number: 24BBU522; Medline SKU # VASC1403, UDI/DI each 10195327366285, UDI/DI case 40195327366286, Lot Number: 23KBJ722; Medline SKU # VASC1404, UDI/DI each 10195327366568, UDI/DI case 40195327366569, Lot Number: 25DBE744; Medline SKU # VASC1404, UDI/DI each 10195327366568, UDI/DI case 40195327366569, Lot Number: 25FBH475; Medline SKU # VASC1405, UDI/DI each 10195327367015, UDI/DI case 40195327367016, Lot Number: 25DBJ392; Medline SKU # VASC1455A, UDI/DI each 10198459025396, UDI/DI
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. DELIVERY PACK, Medline SKU # DYNJ42892F; 2. DELIVERY PACK, Medline SKU # DYNJ42892G.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25GMD696; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25EMJ573; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25DMC646; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25BMD630; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24LMA523; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24KMA084; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24JME306; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24FME624; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24EMF099; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 26BMH149; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 26AMD029; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 25KMA060; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 25IMA514.
Apr 15, 2026
View details →Molded products inc
High PriorityActive
See Luer Cap Set, MPC-130, set, administration, intravascular
Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.
UDI +B144MPC1300/$$529105203895, Lot Number 20389
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, UDI (01)00827002564244(17)261130(10)16288039, Lot Number 16288039; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, UDI (01)00827002210530(17)260430(10)16029543, Lot Number 16029543; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15681111, Lot Number 15681111; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15646726, Lot Number 15646726; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15721094, Lot Number 15721094; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260131(10)15620729, Lot Number 15620729; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260131(10)15583884, Lot Number 15583884; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15518185, Lot Number 15518185; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15473132, Lot Number 15473132; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15489080, Lot Number 15489080; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)261130(10)15971893, Lot Number 15971893; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15496527, Lot Number 15496527; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15484931, Lot Number 15484931; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251219(10)15466662, Lot Number 15466662; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260930(10)15970575, Lot Number 15970575; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16240911, Lot Number 16240911; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270131(10)16042197, Lot Number 16042197; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16285631, Lot Number 16285631; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16402573, Lot Number 16402573; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16320650, Lot Number 16320650; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260430(10)15899340, Lot Number 15899340; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270819(10)16360511, Lot Number 16360511; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16292003, Lot Number 16292003; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16205619, Lot Number 16205619; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270331(10)16191665, Lot Number 16191665; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270731(10)16300455, Lot Number 16300455; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270131(10)16075768, Lot Number 16075768; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16454763, Lot Number 16454763; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16379974, Lot Number 16379974; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260430(10)15878712, Lot Number 15878712; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260531(10)15797112, Lot Number 15797112; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260531(10)15832325, Lot Number 15832325; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260331(10)15796744, Lot Number 15796744; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260831(10)15841288, Lot Number 15841288; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, UDI (01)00827002444317(17)261130(10)16256021, Lot Number 16256021; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, UDI (01)00827002444324(17)270131(10)16368587, Lot Number 16368587; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, UDI (01)00827002444324(17)260430(10)16056219, Lot Number 16056219.
Apr 15, 2026
View details →Spacelabs healthcare, inc.
High PriorityActive
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
Serial Numbers: UDI-DI: 10841522106415, 10841522106422. 1496-223736, 1496-223737, 1496-223738, 1496-224375, 1496-224376, 1496-224400, 1496-224401, 1496-224402, 1496-224403, 1496-224404, 1496-224405, 1496-224406, 1496-223850, 1496-223851, 1496-223852, 1496-224448, 1496-224956, 1496-224957, 1496-224958, 1496-224959, 1496-224960, 1496-224961, 1496-224981, 1496-224258, 1496-223595, 1496-223596, 1496-223597, 1496-223598, 1496-223619, 1496-223620, 1496-223621, 1496-223622, 1496-223623, 1496-223624, 1496-224717, 1496-224718, 1496-223854, 1496-224373, 1496-224374, 1496-223894, 1496-223895, 1496-223896, 1496-223897, 1496-223898, 1496-223899, 1496-223900, 1496-223901, 1496-223902, 1496-223903, 1496-223904, 1496-223905, 1496-223906, 1496-223907, 1496-223918, 1496-225043, 1496-225044, 1496-225045, 1496-225046, 1496-225047, 1496-225048, 1496-225049, 1496-225050, 1496-225051, 1496-225052, 1496-225053, 1496-225054, 1496-225055, 1496-225056, 1496-225057, 1496-225058, 1496-225059, 1496-225060, 1496-225061, 1496-225062, 1496-225063, 1496-225064, 1496-225065, 1496-225066, 1496-225067, 1496-225068, 1496-224949, 1496-223760, 1496-223761, 1496-225154, 1496-224639, 1496-224719, 1496-224720, 1496-224721, 1496-225088, 1496-225089, 1496-224672, 1496-223908, 1496-223909, 1496-223910, 1496-223911, 1496-223912, 1496-223913, 1496-223914, 1496-223915, 1496-223916, 1496-223917, 1496-224637, 1496-224638, 1496-224752, 1496-224744, 1496-224745, 1496-224746, 1496-224747, 1496-224407, 1496-224408, 1496-224409, 1496-224410, 1496-224411, 1496-224412, 1496-224413, 1496-224414, 1496-224415, 1496-224416, 1496-224417, 1496-224418, 1496-224419, 1496-224420, 1496-224421, 1496-224753, 1496-224754, 1496-224755, 1496-224756, 1496-224757, 1496-225129, 1496-223825, 1496-223826, 1496-223829, 1496-223830, 1496-223831, 1496-223832, 1496-223833, 1496-223834, 1496-223835, 1496-223836, 1496-223837, 1496-223838, 1496-223839, 1496-222928, 1496-222929, 1496-223774, 1496-223775, 1496-224063, 1496-224064, 1496-223580, 1496-223618, 1496-223313, 1496-223314, 1496-223315, 1496-223316, 1496-223317, 1496-223318, 1496-223319, 1496-223320, 1496-223321, 1496-223322, 1496-223323, 1496-223325, 1496-223326, 1496-223327, 1496-223328, 1496-223330, 1496-223331, 1496-223332, 1496-223333, 1496-223334, 1496-223335, 1496-223336, 1496-223337, 1496-223338, 1496-223339, 1496-223340, 1496-223341, 1496-223342, 1496-223419, 1496-223420, 1496-223421, 1496-223422, 1496-223423, 1496-223424, 1496-223425, 1496-223426, 1496-223427, 1496-223428, 1496-223429, 1496-223430, 1496-223431, 1496-223432, 1496-223433, 1496-223434, 1496-223435, 1496-223436, 1496-223437, 1496-223438, 1496-223439, 1496-223440, 1496-223441, 1496-223442, 1496-223443, 1496-223444, 1496-223445, 1496-223446, 1496-223447, 1496-223448, 1496-223449, 1496-223450, 1496-223451, 1496-223452, 1496-223453, 1496-223454, 1496-223455, 1496-223456, 1496-223457, 1496-223458, 1496-223459, 1496-223460, 1496-223461, 1496-223462, 1496-223463, 1496-223464, 1496-223465, 1496-223466, 1496-223467, 1496-223468, 1496-223469, 1496-223470, 1496-223471, 1496-223472, 1496-223473, 1496-223474, 1496-223475, 1496-223476, 1496-223477, 1496-223478, 1496-223479, 1496-223480, 1496-223481, 1496-223482, 1496-223483, 1496-223484, 1496-223485, 1496-223486, 1496-223487, 1496-223488, 1496-223489, 1496-223490, 1496-223491, 1496-223492, 1496-223493, 1496-223494, 1496-223495, 1496-223496, 1496-223497, 1496-223498, 1496-223499, 1496-223500, 1496-223501, 1496-223502, 1496-223503, 1496-223504, 1496-223505, 1496-223506, 1496-223507, 1496-223508, 1496-223509, 1496-223510, 1496-223511, 1496-223512, 1496-223513, 1496-223514, 1496-223515, 1496-223516, 1496-223517, 1496-223518, 1496-223519, 1496-223520, 1496-223521, 1496-223522, 1496-223523, 1496-223524, 1496-223525, 1496-223526, 1496-223527, 1496-223528, 1496-223529, 1496-223530, 1496-223531, 1496-223532, 1496-223533, 1496-223534, 1496-223535, 1496-223536, 1496-223537, 1496-223538, 1496-223539, 1496-223540, 1496-223541, 1496-223542, 1496-223543, 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1496-224520, 1496-224521, 1496-224522, 1496-224523, 1496-224524, 1496-224525, 1496-224526, 1496-224527, 1496-224528, 1496-224926, 1496-224927, 1496-224928, 1496-224929, 1496-224930, 1496-224931, 1496-224932, 1496-224933, 1496-224934, 1496-224935, 1496-224936, 1496-224937, 1496-224938, 1496-224939, 1496-224940, 1496-224941, 1496-224942, 1496-224943, 1496-224944, 1496-224945, 1496-224946, 1496-224947, 1496-224948, 1496-224950, 1496-224951, 1496-224952, 1496-224953, 1496-224954, 1496-224955, 1496-224363, 1496-224364, 1496-224365, 1496-224366, 1496-224367, 1496-224368, 1496-224369, 1496-224370, 1496-224371, 1496-224372, 1496-224767, 1496-224631, 1496-225142, 1496-225143, 1496-225144, 1496-225145, 1496-224429, 1496-224430, 1496-224431, 1496-224432, 1496-224433, 1496-224434, 1496-224435, 1496-224436, 1496-224437, 1496-224438, 1496-224439, 1496-224440, 1496-224441, 1496-224442, 1496-224443, 1496-224444, 1496-224445, 1496-224446, 1496-223739, 1496-223740, 1496-223741, 1496-223742, 1496-223743, 1496-223744, 1496-223745, 1496-223746, 1496-223747, 1496-223748, 1496-224662, 1496-223652, 1496-223653, 1496-223654, 1496-223655, 1496-223656, 1496-223657, 1496-223658, 1496-223659, 1496-223660, 1496-223661, 1496-225018, 1496-225019, 1496-225020, 1496-225021, 1496-225022, 1496-225023, 1496-225024, 1496-225025, 1496-225026, 1496-225027, 1496-225028, 1496-225029, 1496-225030, 1496-225031, 1496-225032, 1496-225033, 1496-225034, 1496-225035, 1496-225036, 1496-225037, 1496-225038, 1496-225039, 1496-225040, 1496-225041, 1496-225042, 1496-225009, 1496-225010, 1496-225011, 1496-225012, 1496-225013, 1496-225014, 1496-223629, 1496-223630, 1496-224784, 1496-224785, 1496-224786, 1496-22478, 1496-224788, 1496-101134, 1496-116983, 1496-224351, 1496-224352, 1496-224353, 1496-224354, 1496-224355, 1496-224356, 1496-224357, 1496-224358, 1496-224359, 1496-224360, 1496-218478, 1496-223858, 1496-223859, 1496-223860, 1496-223861, 1496-223862, 1496-223863, 1496-223864, 1496-223865, 1496-223866, 1496-223867, 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1496-224299, 1496-224300, 1496-224301, 1496-224302, 1496-224303, 1496-224304, 1496-224305, 1496-224306, 1496-224307, 1496-224308, 1496-224309, 1496-224310, 1496-224311, 1496-224312, 1496-224388, 1496-224389, 1496-224390, 1496-224391, 1496-224392, 1496-224393, 1496-224394, 1496-224395, 1496-224396, 1496-216880, 1496-224190
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673D
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # DYNJ63673D, UDI/DI each 10195327304843, UDI/DI case 40195327304844 , Lot Number: 25GLA141
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-CAE-14.0-83-EXTU, UDI (01)00827002240735(17)270509(10)16010654, Lot Number 16010654.
Apr 15, 2026
View details →Beckman coulter, inc.
High PriorityActive
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYNJ57032D; 2. NEURO INTERVENTIONAL RADIOLOGY, Medline SKU # DYNJ64026C; 3. NEURO INERVENTIONAL RADIOLOGY, Medline SKU # VASC1650.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # DYNJ57032D, UDI/DI each 10198459183850, UDI/DI case 40198459183851, Lot Number: 25HBN999; Medline SKU # DYNJ57032D, UDI/DI each 10198459183850, UDI/DI case 40198459183851, Lot Number: 25HBO039; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24JBC741; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24IBM270; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24IBE756; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24GBC735; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24FBF002; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24DBC238; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24ABY360; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 23LBH735; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 26ABP305; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 26ABI725; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25KBD893; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25HBM531; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25HBA055; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25EBC929; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25DBL096; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25DBD577; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25DBI493; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25ABI074; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 24LBG466; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 26BBG430; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25LBC439.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
1. Medline SKU # DYNJ30880M, UDI/DI each 10198459446207, UDI/DI case 40198459446208, Lot Number: 25LMJ532; 2. Medline SKU # DYNJ64295A, UDI/DI each 10193489353853, UDI/DI case 40193489353854, Lot Number: 24KMI274.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 4. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 5. THYROIDECTOMY, Medline SKU # DYNJ910458; 6. LH 3 PORT W/O WASTEBAG, Medline SKU # VASC1081C; 7. LHK, Medline SKU # VASC1510; 8. LHK, Medline SKU # VASC1510.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # CDS780138K, UDI/DI each 10198459205552, UDI/DI case 40198459205553, Lot Number: 25EBR802; Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 25AMH487; Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 24JMC622; Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 24EMD869; Medline SKU # DYNJ910458, UDI/DI each 10195327692469, UDI/DI case 40195327692460, Lot Number: 24LLA039; Medline SKU # VASC1081C, UDI/DI each 10195327054519, UDI/DI case 40195327054510, Lot Number: 25HBU295; Medline SKU # VASC1510, UDI/DI each 10195327686888, UDI/DI case 40195327686889, Lot Number: 24GBO586; Medline SKU # VASC1510, UDI/DI each 10195327686888, UDI/DI case 40195327686889, Lot Number: 24EBG342.
Apr 15, 2026
View details →Xtant medical holdings, inc
High PriorityActive
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
UDI/DI M697X0736555DL1, Lot Number 4375-01
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # DYNJ68037C, UDI/DI each 10198459239328, UDI/DI case 40198459239329, Lot Number: 25HBV397; Medline SKU # DYNJ89845, UDI/DI each 10198459292460, UDI/DI case 40198459292461, Lot Number: 25CBU222; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 26BBC195; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 26ABI611; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25LBK402; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25KBH371; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25IBK975; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25HBQ426.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU DYNJ42367B UDI/DI each 10193489211511, UDI/DI case 40193489211512, Lot Numbers: 24FBJ579, 24DBL828, 24DBE055, 24CBG967, 24ABN254, 23LBI540, 23KBF222, 23JBM761, 23JBA270, 23HBY791, 23HBD212, 23GBJ794, 23FBK893, 23EBQ313, 23DBC465.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270730(10)16183353X, Lot Number 16183353X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270524(10)16076948, Lot Number 16076948; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260222(10)15473203X, Lot Number 15473203X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260201(10)15476984X, Lot Number 15476984X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)261020(10)15719188X, Lot Number 15719188X; Reference Part Number C-PTISY-100-UNL-HC-G-NA, UDI (01)00827002577060(17)270814(10)16205108, Lot Number 16205108; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270528(10)16080161X, Lot Number 16080161X; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270901(10)16435112, Lot Number 16435112.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number APMY-2.5-15-0-2.5, UDI (01)00827002584129(17)270212(10)15894185X, Lot Number 15894185X; Reference Part Number APMY-2.5-15-0-2.5, UDI (01)00827002584129(17)261108(10)15747314X, Lot Number 15747314X; Reference Part Number APMY-4.0-21J-1-12, UDI (01)00827002584198(17)260202(10)15264260X, Lot Number 15264260X;
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-TCCSB-500-UNI, UDI (01)00827002321939(17)270803(10)NS16189671, Lot Number NS16189671; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191668, Lot Number 16191668; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195472, Lot Number 16195472; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195467, Lot Number 16195467; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191666, Lot Number 16191666; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191677, Lot Number 16191677; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191661, Lot Number 16191661; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270812(10)16200360, Lot Number 16200360; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270731(10)16185929, Lot Number 16185929; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270904(10)16237917, Lot Number 16237917; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191674, Lot Number 16191674; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191671, Lot Number 16191671; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193388, Lot Number 16193388; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193387, Lot Number 16193387; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191667, Lot Number 16191667; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195473, Lot Number 16195473; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191662, Lot Number 16191662; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191689, Lot Number 16191689; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195468, Lot Number 16195468; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270927(10)16271019, Lot Number 16271019.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
1. Medline SKU 70075027, UDI/DI each 10193489065831, UDI/DI case 30193489065835, Lot Numbers: 0000077215, 0000079109, 0000082289, 0000084363, 0000090369, 0000107045, 0000114900, 0000120770, 0000122275, 0000125531, 0000125834, 0000132127, 0000132132, 0000135020, 0000135023, 0000137279, 0000141698, 0000141699, 0000144189, 0000147731, 0000149644, 0000151436; 2. Medline SKU 70085007, UDI/DI each 10193489065954, UDI/DI case 30193489065958, Lot Numbers: 0000074193, 0000077204, 0000077974, 0000079512, 0000083156, 0000085956, 0000086070, 0000086483, 0000090174, 0000090816, 0000090917, 0000092492, 0000094095, 0000096914, 0000098330, 0000099425, 0000100711, 0000100826, 0000101994, 0000113588, 0000116407, 0000116708, 0000117321, 0000119569, 0000120349, 0000121439, 0000121700, 0000123467, 0000124590, 0000126063, 0000127845, 0000132989, 0000134342, 0000134345, 0000134741, 0000136418, 0000138294, 0000141336, 0000147492, 0000149666, 0000150547, 0000152486, 0000152797, 0000155541, 0000156129, 0000156574, 0000158566, 0000164128, 0000166270, 0000167879, 0000167880, 0000168660, 0000170215, 0000170237, 0000171147, 0000172275, 0000173410, 0000187298, 0000187601, 0000187638; 3. Medline SKU 70085107, UDI/DI each 10193489065961, UDI/DI case 20193489065968, Lot Numbers: 0000075384, 0000096807, 0000133033, 0000147541, 0000154518, 0000167033, 0000179525; 4. Medline SKU 70087007, UDI/DI each 0000075190, G4UDI/DI case 10193489065985, Lot Numbers: 0000075190, 0000075227, 0000078287, 0000089093, 0000090805, 0000090975, 0000093951, 0000094198, 0000094735, 0000096910, 0000101139, 0000101618, 0000105984, 0000106005, 0000107037, 0000109850, 0000110377, 0000111490, 0000111537, 0000112994, 0000113248, 0000113383, 0000113633, 0000117395, 0000121309, 0000122108, 0000123468, 0000124591, 0000127017, 0000128278, 0000129370, 0000130125, 0000132167, 0000134842, 0000138681, 0000140049, 0000153343, 0000156539, 0000157741, 0000159414, 0000166268, 0000167626, 0000167639, 0000169163, 0000172756, 0000176061, 0000178804, 0000182016, 0000186160, 0000187605; 5. Medline SKU 70087107, UDI/DI each 10193489065992, UDI/DI case 30193489065996, Lot Numbers: 0000078897, 0000148131, 0000157141, 0000163681, 0000167174, 0000168020, 0000170851, 0000176075, 0000182252, 0000192254; 6. Medline SKU 70088007, UDI/DI each 10193489066012, UDI/DI case 30193489066016, Lot Numbers: 0000077187, 0000086247, 0000090162, 0000095619, 0000104749, 0000109521, 0000119070, 0000122098, 0000125541, 0000135421, 0000138529, 0000141833, 0000156061, 0000157744, 0000161113, 0000163952, 0000168023, 0000172923, 0000178145, 0000186934; 7. Medline SKU 70095007, UDI/DI each 10193489066036, UDI/DI case 30193489066030, Lot Numbers: 0000074195, 0000077218, 0000078891, 0000083117, 0000084495, 0000086795, 0000088301, 0000089971, 0000096912, 0000109777, 0000114876, 0000118512, 0000118674, 0000120001, 0000120780, 0000121233, 0000121698, 0000122711, 0000128697, 0000131996, 0000135597, 0000137025, 0000138175, 0000140916, 0000147679, 0000150532, 0000159176, 0000161098, 0000161137, 0000166266, 0000167160, 0000170152; 8. Medline SKU 70095107, UDI/DI each 10193489066043, UDI/DI case 30193489066047, Lot Numbers: 0000088193, 0000090703, 0000091441, 0000108589, 0000112295, 0000113957, 0000114591, 0000114910, 0000116253, 0000117305, 0000121678, 0000122871, 0000125011, 0000125016, 0000126248, 0000132001, 0000147323, 0000147489; 9. Medline SKU 70097007, UDI/DI each 10193489066067, UDI/DI case 30193489066061, Lot Numbers: 0000079553, 0000087472, 0000088541, 0000094831, 0000131995, 0000156391, 0000157135, 0000162685; 10. Medline SKU 70097107, UDI/DI each 10193489066074, UDI/DI case 30193489066078, Lot Numbers: 0000075365, 0000079731, 0000087346, 0000094790, 0000100287, 0000104614, 0000105597, 0000109564, 0000110688, 0000118408, 0000119439, 0000122041, 0000124165, 0000125525, 0000131987, 0000133030, 0000137305, 0000147507, 0000147678, 0000153736, 0000161611, 0000165564, 0000181799, 0000184713, 0000185058, 0000190607; 11. Medline SKU 70098107, UDI/DI each 10193489066104, UDI/DI case 30193489066108, Lot Numbers: 0000095693, 0000111595, 0000131985, 0000159175; 12. Medline SKU 80075027. UDI/DI each 10193489066739, UDI/DI case 30193489066733, Lot Numbers: 0000073773, 0000075166, 0000077039, 0000088354, 0000090588, 0000095298, 0000098304, 0000103809, 0000116987, 0000117782, 0000121306, 0000125285, 0000125804, 0000126247, 0000131716, 0000132243, 0000134967, 0000135264, 0000137714, 0000141733, 0000144473, 0000147785, 0000149296, 0000169772, 0000175145, 0000176267, 0000181484, 0000188304, 0000189612, 0000190429, 0000192341; 13. Medline SKU 80085007, UDI/DI each 10193489066838, UDI/DI case 30193489066832, Lot Numbers: 0000069912, 0000070209, 0000070784, 0000070861, 0000071257, 0000071264, 0000071267, 0000072311, 0000073893, 0000074209, 0000074673, 0000074674, 0000075332, 0000075764, 0000077366, 0000077812, 0000079410, 0000080614, 0000080615, 0000080915, 0000081405, 0000081771, 0000083753, 0000084309, 0000085601, 0000085648, 0000085686, 0000086214, 0000086721, 0000086834, 0000087070, 0000088596, 0000088657, 0000089423, 0000089903, 0000090105, 0000094136, 0000094420, 0000096230, 0000099930, 0000102515, 0000102993, 0000102995, 0000102996, 0000103488, 0000103555, 0000106721, 0000106964, 0000107510, 0000107536, 0000107959, 0000108049, 0000108050, 0000109430, 0000109592, 0000110369, 0000110800, 0000110820, 0000110918, 0000111345, 0000112227, 0000112968, 0000114117, 0000115122, 0000115130, 0000115133, 0000115715, 0000116669, 0000117287, 0000117333, 0000117592, 0000119131, 0000119132, 0000120359, 0000120378, 0000120379, 0000120477, 0000120926, 0000121795, 0000121799, 0000121856, 0000121863, 0000122659, 0000123853, 0000123896, 0000124655, 0000125050, 0000126181, 0000126182, 0000126183, 0000126184, 0000127096, 0000127134, 0000130082, 0000130189, 0000130543, 0000130888, 0000131003, 0000131298, 0000132780, 0000132835, 0000133210, 0000134869, 0000135426, 0000135751, 0000135757, 0000137216, 0000137259, 0000139521, 0000140407, 0000140436, 0000140460, 0000141378, 0000142312, 0000143949, 0000144525, 0000144816, 0000144858, 0000146335, 0000146688, 0000147279, 0000147758, 0000148526, 0000148881, 0000149157, 0000149356, 0000149534, 0000149591, 0000150043, 0000150047, 0000150277, 0000150927, 0000150974, 0000151304, 0000151311, 0000151562, 0000151735, 0000153278, 0000153284, 0000154621, 0000154788, 0000155411, 0000155753, 0000156008, 0000156801, 0000157245, 0000157352, 0000157358, 0000157585, 0000157587, 0000158717, 0000159713, 0000159723, 0000159984, 0000160326, 0000160371, 0000161181, 0000162113, 0000162661, 0000162717, 0000162771, 0000162801, 0000164285, 0000164301, 0000164302, 0000165507, 0000165537, 0000166941, 0000167627, 0000168370, 0000168574, 0000170238, 0000170490, 0000170657, 0000170658, 0000170774, 0000172184, 0000172253, 0000172513, 0000172514, 0000172515, 0000172517, 0000172518, 0000173418, 0000173434, 0000173451, 0000174052, 0000174053, 0000174725, 0000174726, 0000174727, 0000175214, 0000175215, 0000175384, 0000175424, 0000175529, 0000176612, 0000176730, 0000176735, 0000176752, 0000177132, 0000177400, 0000177401, 0000177413, 0000177961, 0000178119, 0000178736, 0000179115, 0000179339, 0000179394, 0000179845, 0000179890, 0000179892, 0000179934, 0000180103, 0000180117, 0000180167, 0000181513, 0000181515, 0000181778, 0000181916, 0000182018, 0000182891, 0000182911, 0000183051, 0000183052, 0000183327, 0000183346, 0000183527, 0000184160, 0000184623, 0000185644, 0000185648, 0000185650, 0000185749, 0000185759, 0000185769, 0000186949, 0000186950, 0000187389, 0000187394, 0000187519, 0000187575, 0000187576, 0000187577, 0000187578, 0000187579, 0000188490, 0000188841, 0000188887, 0000188910, 0000189111, 0000189112, 0000189155, 0000189196, 0000189197; 14. Medline SKU 80087007, UDI/DI each 10193489066852, UDI/DI case 30193489066856, Lot Numbers: 0000069251, 0000069917, 0000069924, 0000069955, 0000072771, 0000077785, 0000077961, 0000080251, 0000080640, 0000081441, 0000081509, 0000082978, 0000083583, 0000084511, 0000085710, 0000086143, 0000087262, 0000088591, 0000089167, 0000089223, 0000089900, 0000090951, 0000092215, 0000092427, 0000093891, 0000094516, 0000094933, 0000095447, 0000095467, 0000096380, 0000097051, 0000099609, 0000099610, 0000103018, 0000103037, 0000103071, 0000106714, 0000107645, 0000108268, 0000108568, 0000109958, 0000110755, 0000110822, 0000111582, 0000114281, 0000114307, 0000115713, 0000115967, 0000117330, 0000117797, 0000118671, 0000119940, 0000120026, 0000120051, 0000120053, 0000120316, 0000120975, 0000121434, 0000122584, 0000122603, 0000122604, 0000124663, 0000124680, 0000125249, 0000125286, 0000126308, 0000126556, 0000126585, 0000126586, 0000127955, 0000128344, 0000129498, 0000129499, 0000130238, 0000132000, 0000132003, 0000132374, 0000132699, 0000133607, 0000133695, 0000134500, 0000134502, 0000134897, 0000135265, 0000135316, 0000137719, 0000137820, 0000139116, 0000139172, 0000140262, 0000140397, 0000140962, 0000140966, 0000141839, 0000141861, 0000142855, 0000142869, 0000143982, 0000143993, 0000144660, 0000145515, 0000145586, 0000145926, 0000146475, 0000146982, 0000146986, 0000147169, 0000147982, 0000148028, 0000148577, 0000149312, 0000149318, 0000149583, 0000150969, 0000151045, 0000151063, 0000151741, 0000151761, 0000153191, 0000153280, 0000154083, 0000154130, 0000154176, 0000155027, 0000155028, 0000155581, 0000156012, 0000156816, 0000157314, 0000157315, 0000158415, 0000159552, 0000159560, 0000159582, 0000159978, 0000160369, 0000162471, 0000162480, 0000162481, 0000162624, 0000162625, 0000162649, 0000164092, 0000164096, 0000164097, 0000164098, 0000164291, 0000164356, 0000164369, 0000164412, 0000164549, 0000165293, 0000165504, 0000165591, 0000165654, 0000166238, 0000166269, 0000166502, 0000167633, 0000167696, 0000167868, 0000167920, 0000167921, 0000167958, 0000167971, 0000169151, 0000170064, 0000170157, 0000170159, 0000170191, 0000170618, 0000171787, 0000171814, 0000171818, 0000172763, 0000172766, 0000173231, 0000173232, 0000173233, 0000173234, 0000173247, 0000174297, 0000174299, 0000174312, 0000174326, 0000174327, 0000175651, 0000176231, 0000176507, 0000176617, 0000177589, 0000177957, 0000178097, 0000178099, 0000178800, 0000179118, 0000179119, 0000179357, 0000179358, 0000179359, 0000179906, 0000179922, 0000180197, 0000181163, 0000181815, 0000182069, 0000182717, 0000182776, 0000182777, 0000182835, 0000183531, 0000183532, 0000183591, 0000183662, 0000184146, 0000184178, 0000184332, 0000184352, 0000184776, 0000184777, 0000185117, 0000185118, 0000185660, 0000185661, 0000186183, 0000186212, 0000186254, 0000186265, 0000186566, 0000186876, 0000187378, 0000187393, 0000187532, 0000187533, 0000187581, 0000187583, 0000187602, 0000187628, 0000188843, 0000188844, 0000188889, 0000189198, 0000189242, 0000189684, 0000189685, 0000189686. 15. Medline SKU 80095007, UDI/DI each 10193489066876, UDI/DI case 20193489066873, Lot Numbers: 0000105201, 0000106354, 0000112875, 0000114278, 0000123107, 0000125259, 0000143729, 0000145697, 0000157989, 0000161262, 0000162833, 0000162869, 0000164539, 0000172176, 0000172859, 0000176097, 0000178913, 0000181201, 0000181321, 0000185560; 16. Medline SKU 80095107, UDI/DI each 10193489066883, UDI/DI case 30193489066887, Lot Numbers: 0000075353, 0000076807, 0000077845, 0000078909, 0000080922, 0000082325, 0000086417, 0000091879, 0000092505, 0000094737, 0000096686, 0000097481, 0000100824, 0000103008, 0000104795, 0000107307, 0000109907, 0000112016, 0000114170, 0000114589, 0000116629, 0000117564, 0000120313, 0000120991, 0000121734, 0000125013, 0000126525, 0000128345, 0000129428, 0000131286, 0000132103, 0000136454, 0000139380, 0000143033, 0000143195, 0000144687, 0000144688, 0000145834, 0000150810, 0000151611, 0000151728, 0000153307, 0000153320, 0000154923, 0000154924, 0000162864, 0000163305, 0000163526, 0000164371, 0000165157, 0000166286, 0000167026, 0000167219, 0000169149, 0000170143, 0000170163, 0000175479, 0000176026, 0000177587, 0000177606, 0000179362, 0000180730, 0000181132, 0000182200, 0000185658, 0000190518, 0000191423; 17. Medline SKU 80097107, UDI/DI each 10193489066906, UDI/DI case 30193489066900, Lot Numbers: 0000077040, 0000103845, 0000108241, 0000109897, 0000112900, 0000124191, 0000131659.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. LAPAROSCOPIC HERNIORRHAPHY DSC, Medline SKU # DYNJ63021B; 2. LAP PACK, Medline SKU # DYNJ64297B; 3. MINOR PROCEDURE PACK, Medline SKU # DYNJ82411.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # DYNJ63021B, UDI/DI each 10193489833775UDI/DI case 40193489833776, Lot Number: 26AMD887; Medline SKU # DYNJ64297B, UDI/DI each 10198459472992UDI/DI case 40198459472993, Lot Number: 26AMA970; Medline SKU # DYNJ82411, UDI/DI each 10195327193232UDI/DI case 40195327193233, Lot Number: 25IMB049.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
1. Medline SKU 70083007, UDI/DI each 10193489065855, UDI/DI case 30193489065859, Lot Numbers: 0000077029, 0000081537, 0000084335, 0000087347, 0000089563, 0000113792, 0000115753, 0000122956, 0000127785, 0000131986, 0000158748, 0000175535, 0000187926; 2. Medline SKU 70084007, UDI/DI each 10193489065893, UDI/DI case 30193489065897, Lot numbers: 0000078186, 0000081539, 0000084274, 0000086756, 0000089554, 0000094842, 0000096918, 0000105613, 0000109479, 0000111244, 0000114562, 0000115421, 0000117317, 0000118251, 0000120265, 0000120769, 0000121714, 0000123466, 0000124589, 0000131984, 0000131989, 0000138071, 0000140322, 0000142850, 0000147002, 0000152069, 0000162694, 0000173507, 0000174662, 0000174773, 0000176555, 0000178806, 0000189895; 3. Medline SKU 70084017, UDI/DI each 10193489065916, UDI/DI case 20193489065913, Lot Numbers: 0000084509, 0000086823, 0000095687, 0000165551, 0000165868, 0000166300; 4. Medline SKU 80083007, UDI/DI each 10193489066753, UDI/DI case 30193489066757, Lot Numbers: 0000097388, 0000127072, 0000135012, 0000137004; 5. Medline SKU 80084007, UDI/DI each 10193489066791, UDI/DI case 30193489066795, Lot Numbers: 0000080553, 0000080919, 0000082969, 0000085041, 0000088044, 0000094514, 0000099870, 0000101882, 0000102372, 0000105155, 0000107328, 0000109442, 0000112810, 0000112966, 0000114317, 0000115744, 0000117572, 0000118722, 0000118962, 0000119950, 0000120931, 0000121305, 0000121393, 0000122583, 0000122606, 0000123102, 0000126198, 0000126566, 0000127132, 0000130798, 0000131678, 0000132838, 0000137176, 0000139543, 0000140507, 0000142057, 0000142279, 0000143110, 0000143264, 0000143714, 0000148872, 0000150059, 0000150488, 0000151054, 0000151295, 0000151300, 0000151768, 0000152754, 0000153438, 0000154148, 0000156028, 0000158045, 0000158122, 0000159113, 0000159652, 0000160479, 0000160753, 0000161269, 0000162083, 0000162090, 0000162336, 0000162895, 0000164540, 0000164541, 0000166504, 0000166983, 0000167995, 0000168000, 0000169147, 0000169560, 0000169793, 0000170823, 0000171778, 0000173402, 0000174087, 0000174697, 0000174747, 0000176011, 0000176240, 0000176850, 0000177923, 0000179193, 0000179414, 0000180511, 0000182186, 0000182779, 0000182782, 0000185643, 0000186234, 0000186874, 0000187362, 0000187363, 0000188837, 0000188842, 0000188845; 6. Medline SKU 80084017, UDI/DI each 10193489066814, UDI/DI case 20193489066811, Lot Numbers: 0000101535, 0000103862, 0000105095, 0000106954, 0000108237, 0000122887, 0000126590, 0000127159, 0000128360, 0000128852, 0000132717, 0000134047, 0000135616, 0000140813, 0000144899, 0000148530, 0000149322, 0000152430, 0000161279, 0000164538, 0000169107, 0000173193, 0000173256, 0000182141, 0000183619, 0000187345, 0000188399.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)260221(10)15133690X, Lot Number 15133690X; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)260314(10)15274382, Lot Number 15274382; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)270104(10)15435573, Lot Number 15435573; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)270118(10)15445615, Lot Number 15445615; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)270104(10)15501690, Lot Number 15501690.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)290214(10)15898546X, Lot Number 15898546X; Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)270115(10)15660224, Lot Number 15660224; Reference Part Number CMW-14-300-18G, UDI (01)00827002507920(17)260718(10)15220204, Lot Number 15220204.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-NTSE-2.4-115-NC3, UDI (01)00827002362505(17)261103(10)15741134, Lot Number 15741134; Reference Part Number C-NTSE-2.4-115-NCT4, UDI (01)00827002362512(17)270118(10)15855141, Lot Number 15855141.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 24BBI341; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23LBP066; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23KBS305; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23JBA062; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23HBR594; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23DBR051; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 24ABO014; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23KBW878; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23HBP761; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23FBW006; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23DBF403; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25KMD905; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25IMD215; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25GMI326; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25FMI653; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25EMH566; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25DMI277; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25AMI608; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMH838; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMB458; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24JME629; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GME647; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB984; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB351; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24EMF938; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24DMH385; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMH336; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMF956; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24BMA898; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24AMA108; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23HMH132; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GMH036; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GME698; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23FMF802; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23EMJ218; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24JMD976; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24HMA010; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMG026; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMB098; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24FMF601; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24EMB438; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24BMA764; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23LME233; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23JMH698; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23IMD171; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23GMD850; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23FMF778; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23EMG560; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25LMG779; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25IMJ214; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25HMF990; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25EMI063; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25DMB127; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25BMF602; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24LMF104; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24KMD144; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24JMA170; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24HMH276; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24HMA390; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24FMD853; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24DMJ147; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24CMH759; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 24BMA225; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23LMB166; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23KMH325; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23IME127; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23HME466; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23FMJ772; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23FMB456; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23EMC182; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 23DMH934; Medline SKU DYNJ57516, UDI/DI each 10889942748426, UDI/DI case 40889942748427, Lot Number 25JMI272; Medline SKU DYNJ57516, UDI/DI each 10889942748426, UDI/DI case 40889942748427, Lot Number 25HMG164; Medline SKU DYNJ57516, UDI/DI each 10889942748426, UDI/DI case 40889942748427, Lot Number 25HMF202; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25LBB437; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25HBV263; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25GBR191; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25GBR194; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25GBR437; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25EBO829; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 25BBR177; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24JBX749; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24JBG123; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24IBJ506; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24FBT677; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24FBH497; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24DBL409; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24BBT394; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 24ABR246; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23LBK160; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23KBJ685; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23IBU014; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23IBG647; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23HBB827; Medline SKU DYNJ58243B, UDI/DI each 10193489791860, UDI/DI case 40193489791861, Lot Number 23FBU409; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 24ABQ959; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23KBF277; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23IBR043; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23HBI873; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23GBA252; Medline SKU DYNJ65185, UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number 23EBM886; Medline SKU VASC1170A, UDI/DI each 10193489774863, UDI/DI case 40193489774864, Lot Number 25HMD546; Medline SKU VASC1184A, UDI/DI each 10193489799828, UDI/DI case 40193489799829, Lot Number 25HBL365; Medline SKU VASC1184A, UDI/DI each 10193489799828, UDI/DI case 40193489799829, Lot Number 25GBL071; Medline SKU VASC1184A, UDI/DI each 10193489799828, UDI/DI case 40193489799829, Lot Number 24GBY914.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834147, Lot Number 15834147.
Apr 15, 2026
View details →Brahms gmbh
High PriorityActive
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.
UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
UDI (01)00827002507869(17)270708(10)15288005, Lot Number 15288005
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # DYNJ80513B, UDI/DI each 10198459389375, UDI/DI case 40198459389376, Lot Numbers: 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993, 25FBU283.
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # DYNJ58475F, UDI/DI each 10198459572388, UDI/DI case 40198459572389, Lot Number: 25LMK173; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26BMA268; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26AMH928; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMD876; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMA519; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25DMA846; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMH004; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMA218; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMI208; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMC007; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24JMD850; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24IMI939; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24EDB694; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24DDB793; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24CDB207; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24BDB439; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDB756; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDA532.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448001(17)280512(10)NS16597252, Lot Number NS16597252; C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448001(17)280513(10)NS16600633, Lot Number NS16600633; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280327(10)16530788, Lot Number 16530788; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280401(10)16537255, Lot Number 16537255; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280417(10)16562522, Lot Number 16562522; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280602(10)16625687, Lot Number 16625687; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280416(10)NS16523791X, Lot Number NS16523791X; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280514(10)NS16523837X, Lot Number NS16523837X; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280603(10)NS16523837XX, Lot Number NS16523837XX; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280324(10)NS16523838, Lot Number NS16523838; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280324(10)NS16523839, Lot Number NS16523839; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280324(10)NS16523840, Lot Number NS16523840; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588043, Lot Number NS16588043; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588056, Lot Number NS16588056; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588057, Lot Number NS16588057; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588058, Lot Number NS16588058; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588059, Lot Number NS16588059; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588060, Lot Number NS16588060; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588061, Lot Number NS16588061; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588062, Lot Number NS16588062; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588063, Lot Number NS16588063; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280507(10)NS16590737, Lot Number NS16590737; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280507(10)NS16590738, Lot Number NS16590738; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280507(10)NS16590739, Lot Number NS16590739; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596195, Lot Number NS16596195; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596196, Lot Number NS16596196; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596197, Lot Number NS16596197; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596198, Lot Number NS16596198; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596199, Lot Number NS16596199; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596200, Lot Number NS16596200; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596201, Lot Number NS16596201; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596202, Lot Number NS16596202; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596430, Lot Number NS16596430; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597248, Lot Number NS16597248; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597249, Lot Number NS16597249; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597269, Lot Number NS16597269; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597270, Lot Number NS16597270; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597271, Lot Number NS16597271; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597272, Lot Number NS16597272; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597273, Lot Number NS16597273; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597274, Lot Number NS16597274; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597275, Lot Number NS16597275; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597276, Lot Number NS16597276; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597277, Lot Number NS16597277; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600640, Lot Number NS16600640; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600641, Lot Number NS16600641; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600642, Lot Number NS16600642; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600653, Lot Number NS16600653; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600654, Lot Number NS16600654; C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448070(17)280602(10)16625668, Lot Number 16625668.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-TQTSY-3200, UDI (01)00827002072428(17)270221(10)NS15796862X, Lot Number NS15796862X; Reference Part Number C-TQTSY-3200, UDI (01)00827002072428(17)270301(10)NS15881832X, Lot Number NS15881832X.
Apr 15, 2026
View details →Cook incorporated
High PriorityActive
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270802(10)16189446, Lot Number 16189446; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270803(10)16189593, Lot Number 16189593; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270725(10)16175956, Lot Number 16175956; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270725(10)16175957, Lot Number 16175957; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270803(10)16189597, Lot Number 16189597; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270725(10)16175953, Lot Number 16175953; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)271001(10)16460934, Lot Number 16460934; Reference Part Number C-PTIS-100-HC-G-NA, UDI (01)00827002576827(17)280318(10)16514949, Lot Number 16514949; Reference Part Number C-PTIS-100-HC-G-NA, UDI (01)00827002576827(17)270725(10)16175948, Lot Number 16175948; Reference Part Number C-PTIS-100-UNL-HC-G-EU, UDI (01)00827002576872(17)260101(10)15151627, Lot Number 15151627; Reference Part Number C-PTIS-100-UNL-HC-G-EU, UDI (01)00827002576872(17)270627(10)16131781, Lot Number 16131781; Reference Part Number C-PTIS-100-UNL-HC-G-EU, UDI (01)00827002576872(17)280218(10)16471138, Lot Number 16471138; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270725(10)16175951, Lot Number 16175951; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270725(10)16175949, Lot Number 16175949; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270724(10)16174015, Lot Number 16174015; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270725(10)16175955, Lot Number 16175955; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270724(10)16174023, Lot Number 16174023; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270801(10)16187746, Lot Number 16187746; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)260327(10)15548776, Lot Number 15548776; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)280121(10)16429827, Lot Number 16429827.
Apr 15, 2026
View details →Stryker sustainability solutions
High PriorityActive
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
5921-018-135 COLOR CUFF SINGLE PORT, SINGLE BLADDER 18" (RED), QUICK CONNECT-018-135 COLOR UDI-DI code: 50885825016024 Serial/Lot Numbers: 0000608407 0000666479 0000710705 0000748402 0000779936 0000806234 0000823124 0000853520 0001026721 0001191140 0000610592 0000668978 0000713274 0000750469 0000782278 0000806424 0000823125 0000856167 0001028153 0001204019 0000613383 0000674814 0000716919 0000753840 0000784288 0000807132 0000824757 0000877820 0001033211 0001217956 0000618222 0000679061 0000720023 0000754633 0000787628 0000808365 0000827488 0000878368 0001058134 0001229508 0000628325 0000680520 0000720933 0000755710 0000788773 0000809629 0000829817 0000884047 0001072723 0001231688 0000634780 0000683417 0000726263 0000756541 0000790106 0000811248 0000831661 0000887355 0001080285 0001238396 0000645259 0000687976 0000729862 0000757389 0000790446 0000811740 0000832427 0000899094 0001087139 0001247960 0000647073 0000689032 0000734825 0000759043 0000792153 0000813049 0000833383 0000904725 0001107907 0001248642 0000649426 0000690670 0000736903 0000766311 0000793178 0000813414 0000839160 0000936850 0001109580 0000650589 0000694958 0000740521 0000770116 0000795030 0000816441 0000842177 0000950419 0001117732 0000650994 0000696012 0000741830 0000771335 0000795826 0000818289 0000843424 0000956337 0001118566 0000652336 0000697626 0000742683 0000773128 0000796587 0000819853 0000846088 0000973851 0001158477 0000658811 0000699733 0000745094 0000775812 0000800461 0000820677 0000848208 0000982970 0001163184 0000662208 0000704540 0000746765 0000777690 0000801547 0000821695 0000850631 0000997622 0001171995 0000663506 0000705054 0000747787 0000778370 0000804320 0000822757 0000852419 0001012102 0001188671 5921-018-235 COLOR CUFF DUAL PORT, SINGLE BLADDER 18" (RED), QUICK CONNECT-018-235 UDI-DI code: 50885825016062 Serial/Lot Numbers: 0000609899 0000650590 0000690671 0000726264 0000763461 0000792154 0000816443 0000840363 0001012101 0001171996 0000610593 0000658812 0000695297 0000727476 0000768855 0000792752 0000818286 0000842180 0001026722 0001188678 0000613711 0000662209 0000696013 0000732858 0000771336 0000795827 0000821298 0000844327 0001029500 0001200103 0000623945 0000666480 0000696720 0000739438 0000773129 0000796588 0000822852 0000846560 0001047460 0001229509 0000626120 0000669025 0000697627 0000740445 0000777026 0000799105 0000826220 0000854710 0001066338 0001247961 0000633577 0000674643 0000703467 0000741831 0000779645 0000802579 0000826374 0000876426 0001079442 0001253084 0000636292 0000675503 0000706848 0000744953 0000783272 0000806235 0000829318 0000888999 0001087140 0001254940 0000638716 0000679066 0000709328 0000751420 0000785086 0000808363 0000829844 0000915425 0001107908 0001259581 0000643088 0000681303 0000712558 0000754295 0000787957 0000809212 0000831758 0000936775 0001114240 0000645991 0000683427 0000717160 0000755547 0000789793 0000812544 0000833100 0000949315 0001118567 0000647074 0000687285 0000720024 0000757390 0000790107 0000815929 0000838765 0000988077 0001158473 5921-024-235 COLOR CUFF DUAL PORT, SINGLE BLADDER 24" (YELLOW), QUICK CONNECT-024-235 UDI-DI code: 50885825016116 Serial/Lot Numbers 0000609378 0000658814 0000700579 0000745097 0000782284 0000808367 0000832426 0000889000 0001012100 0001204021 0000610595 0000663505 0000703816 0000746163 0000783274 0000809214 0000832864 0000891969 0001026723 0001218006 0000611745 0000667625 0000705436 0000748057 0000785984 0000811249 0000835176 0000900056 0001028154 0001222644 0000614822 0000672680 0000708327 0000749928 0000786744 0000812293 0000838774 0000906961 0001033218 0001230940 0000618126 0000674644 0000710704 0000754296 0000787958 0000813050 0000842178 0000913984 0001058124 0001247962 0000621163 0000675505 0000712560 0000756186 0000789257 0000813513 0000844340 0000920455 0001066337 0001253080 0000623947 0000679068 0000713835 0000757391 0000790109 0000815931 0000845669 0000924209 0001079438 0001254942 0000625488 0000680521 0000716921 0000758216 0000792155 0000819855 0000846562 0000930032 0001082058 0000629193 0000681987 0000720026 0000763463 0000792754 0000820680 0000848744 0000936882 0001087141 0000632783 0000683415 0000722711 0000770118 0000795825 0000822396 0000850633 0000940957 0001109728 0000634781 0000686675 0000726265 0000771337 0000797234 0000823128 0000852266 0000948040 0001114237 0000642067 0000688508 0000727477 0000773131 0000799971 0000824755 0000853523 0000950415 0001143575 0000645260 0000689009 0000732859 0000775810 0000800826 0000826376 0000854865 0000973852 0001158478 0000647568 0000693830 0000734824 0000777688 0000803213 0000828382 0000856461 0000977519 0001171997 0000650689 0000695724 0000739439 0000778675 0000803622 0000829857 0000878369 0000988075 0001178624 0000654974 0000696014 0000741833 0000779991 0000806427 0000831660 0000882363 0001000210 0001181619
Apr 15, 2026
View details →Medline industries, lp
High PriorityActive
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000073035; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000075896; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000078648; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082387; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082384; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000087087; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093180; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093741; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000095735; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102248; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102694; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000105537; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000107947; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000113756; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000117610; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000118566; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000122251; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000124476; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000126969; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000131544; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000134543; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000139258; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000140972; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000141871; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000148316; Medline SKU # 60010034, UDI/DI each 10193489087246, UDI/DI case 20193489087243, Lot Number: 0000071568; Medline SKU # 60010034, UDI/DI each 10193489087246, UDI/DI case 20193489087243, Lot Number: 0000081594; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000078094; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000090667; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000100891; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000102756; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000106009; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000070691; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000074251; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000076643; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000079468; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000083282; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000086207; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000087266; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000090244; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000093925; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000096371; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000098671; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000104426; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000109080; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000112855; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000116425; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000116426; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000119589; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000126646; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000128838; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000130953; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000132140; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000133876; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000135397; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000139982; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000140796; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000148434; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000153838; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000157175; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000070753; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000072331; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000075946; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000080752; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000083175; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000085929; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000091637; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000091667; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000092995; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000095615; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000097091; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000102177; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000104282; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000108922; Medline SKU # 60010195, UDI/DI each 10193489040234, UDI/DI case 20193489040217, Lot Number: 0000110250; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000085433; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000089290; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000091926; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000098742; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000100867; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000103336; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000112524; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000120251; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000123676; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000126203; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000133960; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000135744; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000140099; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000142801; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000144713; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000146930; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000149252; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000152505; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000155032; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000159209; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000163547; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000168371; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000173236; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000173695; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000177889; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000180765; Medline SKU # 60010468, UDI/DI each 10193489040319, UDI/DI case 20193489040231, Lot Number: 0000185246; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000072395; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000073901; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000076691; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000077496; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000081475; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000088337; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000088765; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000101624; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000102812; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000103066; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000103067; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000115029; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000115033; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000118177; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000119095; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000120197; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000123747; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000125425; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000128384; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000129206; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000139424; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000146703; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000151616; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000152848; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000153236; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000156113; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000160838; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000166550; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000169399; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000174037; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000174009; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000183683; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000183682; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000183681; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000186609; Medline SKU # 60010493, UDI/DI each 10193489040333, UDI/DI case 20193489040316, Lot Number: 0000186610; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000073135; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000074662; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000074664; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000075865; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000101553; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000103798; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 20193489040330, Lot Number: 0000122264; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000070837; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000077023; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000093083; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000101551; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000105041; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000111469; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000123748; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000131345; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000138685; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000144169; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000149803; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000156861; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000160435; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000165962; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000170641; Medline SKU # 60010535, UDI/DI each 10193489040388, UDI/DI case 30193489040382, Lot Number: 0000177104; Medline SKU # 60011044, UDI/DI each 10193489040449, UDI/DI case 20193489040385, Lot Number: 0000104443; Medline SKU # 60011044, UDI/DI each 10193489040449, UDI/DI case 20193489040385, Lot Number: 0000106377; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000070619; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000076571; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000080522; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000087199; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000093127; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000096425; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000097857; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000113192; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000120761; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000132347; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000138672; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000148332; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000150592; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000181532; Medline SKU # 60011045, UDI/DI each 10193489040456, UDI/DI case 20193489040453, Lot Number: 0000183035; Medline SKU # 60011433, UDI/DI each 10193489040470, UDI/DI case 30193489040474, Lot Number: 0000084227; Medline SKU # 60011433, UDI/DI each 10193489040470, UDI/DI case 30193489040474, Lot Number: 0000101486; Medline SKU # 60012101, UDI/DI each 10193489040579, UDI/DI case 30193489040573, Lot Number: 0000082991; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000077557; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000086285; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000094509; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000113316; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000127192; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000135691; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000145671; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000152031; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000160880; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000165579; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000173427; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000177927; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000183390; Medline SKU # 60012141, UDI/DI each 10193489040593, UDI/DI case 30193489040597, Lot Number: 0000188216; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000070185; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000073240; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000076727; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000079069; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000082697; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000086202; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000086434; Medline SKU # 60012315, UDI/DI each 10193489089219, UDI/DI case 30193489089213, Lot Number: 0000090649; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000072816; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000077173; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000079794; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000091220; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000091833; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000095789; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000097737; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000104805; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000106258; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000114948; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000115856; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000129215; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000129501; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000131536; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000138730; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000143661; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000144820; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000145579; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000148112; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000150651; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000176144; Medline SKU # 60012911, UDI/DI each 10193489040685, UDI/DI case 20193489089216, Lot Number: 0000188261; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000070073; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000073128; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000076474; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000078282; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000081428; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000086197; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000093782; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000096363; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000097380; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000098743; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000105137; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000106046; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000111206; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000114190; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000115831; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000118695; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000123787; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000128251; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000133072; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000138228; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000140367; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000144535; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000149547; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000152488; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000155300; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000162783; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000166461; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000168363; Medline SKU # 60013001, UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 0000168433; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000078052; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000081986; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000096424; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000140482; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000154034; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000158778; Medline SKU # 60013042, UDI/DI each 10193489040739, UDI/DI case 20193489040712, Lot Number: 0000172894; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000079144; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000081487; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000088809; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000093807; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000098370; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000102015; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000104687; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000107324; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000109984; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000116869; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000124230; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000129398; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000133867; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000156445; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000156915; Medline SKU # 60013101, UDI/DI each 10193489040746, UDI/DI case 20193489040736, Lot Number: 0000160817; Medline SKU # 60013112, UDI/DI each 10193489040753, UDI/DI case 20193489040743, Lot Number: 0000110228; Medline SKU # 60013112, UDI/DI each 10193489040753, UDI/DI case 20193489040743, Lot Number: 0000112533; Medline SKU # 60013112, UDI/DI each 10193489040753, UDI/DI case 20193489040743, Lot Number: 0000161094; Medline SKU # 60018523, UDI/DI each 10193489040869, UDI/DI case 20193489040750, Lot Number: 0000112984; Medline SKU # 60018651, UDI/DI each 10193489040876, UDI/DI case 20193489040866, Lot Number: 0000073841; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000073746; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000077471; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000083091; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000083747; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000087523; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000090213; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000091658; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000095413; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000096109; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000099022; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000099532; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000115874; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000119624; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000125077; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000128639; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000131692; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000137761; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000141735; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000144496; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000151526; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000155679; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 20193489040873, Lot Number: 0000157736; Medline SKU # 60020201, UDI/DI each 10193489040944, UDI/DI case 201934890
Apr 15, 2026
View details →Mentor texas, lp.
High PriorityActive
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722003; UDI: N/A; System Serial Number: 445, 1555, 1084, 1411, 1232, 1259, 1023, 1947, 392, 1133, 1135, 1627, 746, 98, 1078, 367, 1584, 1599, 1153, 1154, 1032, 1694, 259, 1471, 1474, 684, 657, 385, 1551, 947, 1360, 1482, 1489, 177, 1634, 1663, 1704, 1214, 546, 1089, 305, 2936, 92, 1092, 1869, 119, 928, 1449, 1805, 998, 501, 503, 1114, 345, 1443, 1444, 8198, 63, 1189, 1954, 1575, 1728, 1430, 147, 1326, 700, 1446, 401, 1615, 939, 527, 1067, 1787, 1529, 104, 342, 390, 1353, 159, 160, 472, 197, 1349, 1271, 653, 917, 997616, 1072, 1594, 574, 892, 1138, 1001, 1950, 447, 1043, 994, 995, 1514, 1525, 1311, 8091, 1472, 1621, 1622, 72, 1187, 1222, 1948, 963, 1700, 1343, 619915, 1667, 463, 959, 1031, 912, 913, 1647, 521, 590, 591, 855, 328A, 696, 1807, 690, 1714, 37, 1799, 1286, 257, 1188, 940, 1512, 1891, 1223, 640, 103, 24, 406, 467, 285, 1637, 453, 833, 1738, 1749, 430, 1491, 1605, 1130, 5, 674, 639, 797, 1033, 1357, 1632, 1631, 391, 281, 1535, 1038, 1045, 1536, 350, 452, 629, 732, 754, 1056, 810, 1610, 1611, 1804, 1122, 1413, 644, 1059, 513, 1163, 1193, 1549, 418, 1778, 1199, 2933, 517, 1597, 1585, 1063, 1596, 337, 1746, 1747, 1619, 288, 988, 535, 1717, 1641, 1395, 411, 412, 413, 414, 415, 1338, 319, 1706, 1572, 1916, 1282, 789, 614, 763, 728, 605, 622, 492, 1612, 1648, 1613, 1568, 1569, 1685, 948, 505, 566, 1297, 895619, 1277, 321, 239, 1216, 328, 329, 190, 1586, 1492, 863, 1616, 359, 1169, 1118, 230, 1421, 1416, 1260, 1609, 115, 1337, 519, 370, 1155, 13, 162, 1478, 1090, 1662, 1818, 1730, 1463, 1752, 1215, 1558, 1578, 1083, 1014, 1378, 985, 1231, 356, 307, 308, 309, 310, 777, 778, 780, 1127, 1167, 1186, 1638, 898, 82, 136, 1646, 1689, 715, 423, 1571, 1101, 1399, 1931, 1149, 753, 1255, 424, 1733, 606, 1247, 751, 1293, 548, 813, 1524, 1457, 1906, 1979, 249, 1509, 937, 1016, 116, 1857, 676, 875, 373, 1774, 1923, 313, 314, 1161, 1919, 1723, 374, 1328, 1664, 750, 1396, 1582, 1445, 1511, 1576, 1680, 1104, 560, 1735, 4516100000005820, 1064, 1458, 949, 1592, 1708, 1709, 265, 1119, 1176, 369, 1230, 1925, 1246, 1755, 1756, 339, 861, 1606, 1649, 1823, 1325, 1633, 596, 1527, 1784, 1834, 464, 1456, 796, 1273, 1110, 1751, 1928, 468, 839, 1025, 272, 1593, 1743, 538, 1684, 1198, 292, 1669, 1630, 1697, 1022, 770, 708, 1, 744, 1125, 1661, 344, 1760, 1567, 1495, 782, 1132, 1483, 1452, 1603, 1207, 1409, 1412, 1500, 1501, 39, 1748, 1414, 1692, 1595, 1203, 1764, 245, 1058, 1027, 346, 961, 1172, 255, 1469, 1112, 1278, 354, 416, 363, 582, 1518, 1666, 1352, 205, 899, 883, 161, 1280, 569, 922, 547, 1691, 1329, 241, 667, 578; (2) System Code: 722010; UDI: 00884838059030; System Serial Number: 1123, 932, 239, 42, 360, 209, 500, 794, 921, 939, 286, 1440, 160, 1144, 521, 33, 107, 1025, 656, 668, 1261, 1170, 585, 364, 1128, 882, 499, 1230, 280, 488, 787, 968, 890, 780, 190, 1181, 694, 1279, 344, 1149, 423, 1176, 1173, 1040, 67, 1309, 763, 931, 306, 478, 240, 1298, 970, 1226, 290, 365, 651, 1275, 1292, 755, 671, 677, 1336, 477, 1078, 467, 65, 1369, 792, 679, 485, 395, 592, 1312, 1302, 505, 229, 414, 714, 785, 647, 1283, 119, 662, 1233, 1234, 1235, 1236, 690, 698, 158, 1009, 992, 1214, 1064, 979, 764, 920, 788, 1396, 902, 1344, 1183, 453, 296, 1118, 411, 1209, 1210, 1041, 1042, 1432, 308, 833, 1310, 728, 791, 480, 1263, 986, 987, 422, 905, 218, 1005, 1425, 1397, 1398, 1132, 468, 127, 1442, 1048, 646, 648, 1126, 252, 873, 1011, 343, 1370, 69, 1391, 838, 999, 175, 285, 636, 624, 241, 1084, 896, 673, 683, 1441, 914, 342, 531, 818, 1395, 637, 917, 214, 1043, 1365, 1109, 1297, 572, 1436, 638, 1112, 1373, 946, 878, 1108, 809, 830, 839, 1069, 1287, 1308, 169, 1424, 604, 605, 777, 666, 1122, 654, 301, 601, 426, 924, 265, 1198, 577, 332, 1047, 1187, 447, 1250, 1147, 1034, 1421, 1258, 193, 652, 1015, 1016, 1017, 1018, 1423, 1332, 1106, 980, 1169, 1438, 322, 251, 278, 868, 383, 782, 125, 52, 697, 523, 707, 708, 1146, 1267, 566, 594, 891, 861, 1321, 1096, 906, 1366, 374, 1363, 243, 524, 382, 1428, 225, 812, 813, 857, 409, 733, 555, 598, 844, 95, 1285, 212, 396, 139, 1055, 1202, 928, 1185, 368, 1374, 772, 410, 58, 786, 126, 1050, 37, 1361, 1153, 1166, 915, 951, 197, 494, 884, 273, 544, 146, 299, 121, 62, 1113, 802, 803, 769, 540, 1385, 192, 1278, 529, 1007, 1305, 1306, 612, 1077, 1093, 1203, 1216, 620, 300, 1058, 1334, 351, 528, 559, 1006, 141, 740, 828, 1192, 715, 635, 520, 570, 384, 90, 811, 53, 901, 223, 1095, 552, 1326, 973, 596, 45, 712, 1148, 1349, 323, 825, 402, 713, 312, 195, 900, 277, 176, 806, 907, 967, 795, 1272, 816, 1154, 1439, 1404, 1431, 63, 346, 157, 1427, 692, 270, 600, 655, 610, 762, 888, 936, 50, 990, 665, 315, 1444, 1003, 1617, 220, 1200, 1152, 819, 613, 614, 634, 136, 944, 255, 817, 1140, 793, 393, 518, 568, 563, 330, 367, 473, 515, 1315, 415, 952, 866, 1002, 1429, 1430, 418, 778, 954, 781, 720, 911, 354, 186, 719, 978, 46, 831, 1067, 1129, 789, 940, 83, 123, 586, 1193, 501, 166, 758, 64, 1056, 1004, 1403, 1141, 86, 111, 1241, 1171, 909, 548, 1371, 1393, 267, 1036, 597, 653, 1086, 88, 1180, 381, 776, 115, 219, 959, 349, 533, 386, 801, 498, 1402, 1053, 997, 116, 579, 211, 404, 428, 503, 493, 1120, 1121, 406, 753, 606, 226, 387, 1452, 495, 1244, 945, 1088, 1245, 996, 137, 297, 1265, 72, 1177, 1178, 128, 525, 625, 1221, 607, 744, 700, 701, 400, 71, 20, 1434, 1392, 984, 1105, 1266, 615, 130, 923, 1208, 1051, 1206, 975, 1168, 253, 398, 1211, 233, 320, 1039, 97, 703, 526, 1237, 650, 98, 427, 496, 1286, 680, 1232, 649, 401, 1194, 774, 963, 876, 275, 660, 885, 800, 264, 228, 699, 1356, 475, 1331, 369, 759, 722, 1384, 1352, 350, 1357, 1098, 1099, 748, 1220, 657, 658, 659, 854, 1325, 565, 506, 734, 735, 736, 737, 642, 1255, 1360, 1054, 391, 425, 513, 1381, 1163, 1164, 1342, 898, 1364, 424, 1368, 105, 993, 732, 1256, 580, 704, 261, 695, 696, 1367, 1353, 1378, 1379, 238, 1389, 1254, 1390, 1394, 706, 1253, 1327, 1165, 1032, 319, 1223, 1252, 739, 1380, 1019, 1023, 541, 731, 1215, 247, 1191, 856, 1375, 1350, 971, 1345, 356, 877, 164, 1125, 960, 272, 1426, 989, 340, 34, 35, 1196, 249, 1294, 114, 80, 1445, 380, 1276, 935, 1242, 224, 106, 104, 1401, 622, 371, 162, 333, 927, 1022, 1000, 930, 1197, 1116, 903, 1435, 91, 1346, 602, 245, 535, 941, 230, 231, 232, 991, 248, 1111, 1029, 742, 222, 797, 254, 416, 1010, 92, 687, 1304, 187, 502, 1124, 174, 537, 1199, 302, 1339, 1001, 1351, 1307, 173, 134, 1137, 282, 483, 96, 847, 1068, 760, 1008, 1213, 1092, 1151, 1268, 955, 711, 1145, 514, 269, 1273, 66, 1157, 1119, 702, 860, 685, 686, 942, 181, 357, 1190, 961, 287, 948, 509, 619, 185, 1104, 887, 394, 304, 863, 799, 1224, 1225, 1021, 1422, 1033, 1136, 998, 154, 834, 1150, 1091, 832, 311, 142, 388, 599, 1188, 217, 235, 236, 1031, 1030, 956, 850, 250, 1097, 904, 199, 328, 182, 294, 103, 1066, 77, 122, 810, 184, 474, 471, 962, 138, 1182, 1090, 549, 1065, 1376, 1433, 1355, 689, 163, 631, 1303, 1155, 558, 804, 1044, 822, 852, 880, 476, 862, 1280, 1300, 858, 362, 1207, 1076, 874, 1218, 1130, 972, 1313, 710, 934, 645, 855, 583, 178, 94; (3) System Code: 722026; UDI: 00884838054189; System Serial Number: 683, 155, 1051, 1052, 618, 654, 786, 1132, 458, 1100, 770, 436, 1338, 1068, 233, 78, 432, 224, 1072, 796, 93, 543, 1248, 561, 1129, 781, 344, 374, 634, 908, 130, 370, 235, 190, 259, 323, 324, 969, 100, 98, 99, 142, 1246, 601, 877, 221, 204, 843, 1038, 1231, 114, 1287, 878, 558, 391, 633, 389, 1050, 1000, 909, 600, 841, 185, 394, 713, 731, 75, 646, 728, 223, 765, 192, 959, 825, 942, 1192, 990, 381, 774, 368, 245, 484, 485, 648, 966, 1268, 109, 110, 116, 604, 319, 627, 716, 396, 531, 156, 253, 965, 1189, 444, 1126, 1210, 1239, 102, 1215, 696, 562, 297, 560, 11, 832, 335, 664, 845, 778, 215, 935, 782, 614, 222, 205, 115, 284, 694, 74, 838, 244, 973, 985, 101, 855, 287, 378, 612, 725, 914, 805, 622, 234, 1293, 121, 512, 1205, 559, 79, 617, 1101, 738, 957, 431, 201, 1340, 122, 653, 663, 688, 563, 704, 462, 191, 931, 967, 265, 826, 998, 534, 807, 961, 962, 986, 1049, 707, 1115, 759, 866, 638, 830, 271, 813, 775, 1316, 343, 406, 252, 748, 616, 1278, 1104, 446, 557, 1368, 358, 310, 497, 977, 471, 334, 65, 461, 1001, 806, 769, 143, 711, 257, 881, 581, 576, 1127, 1128, 1258, 1307, 311, 90, 1092, 276, 722, 1188, 1326, 809, 1067, 404, 729, 894, 477, 18, 1018, 1201, 1202, 126, 164, 455, 542, 566, 978, 326, 1204, 564, 541, 1227, 1349, 231, 77, 1220, 1221, 746, 448, 650, 401, 794, 146, 69, 681, 690, 545, 1228, 1321, 1071, 188, 189, 174, 387, 1341, 897, 619, 1107, 302, 1033, 804, 677, 678, 424, 1271, 587, 1347, 332, 584, 578, 454, 1037, 354, 355, 709, 1203, 356, 930, 172, 911, 134, 294, 346, 609, 569, 141, 596, 177, 979, 452, 1054, 1093, 1313, 161, 182, 717, 924, 928, 960, 1233, 388, 720, 721, 1117, 96, 1146, 510, 858, 744, 745, 420, 1272, 508, 1249, 494, 459, 193, 423, 590, 364, 1091, 1064, 863, 7, 697, 159, 535, 536, 692, 756, 628, 237, 197, 749, 385, 968, 586, 768, 611, 249, 1148, 1121, 17, 273, 43, 203, 1108, 1264, 1265, 40, 132, 217, 662, 754, 478, 1031, 997, 1026, 1029, 1113, 1123, 1199, 1305, 1329, 1355, 1356, 1360, 1361, 1362, 1363, 1364, 1366, 228, 269, 270, 372, 375, 425, 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710, 524, 290, 1151, 706, 532, 442, 443, 547, 417, 1357, 38, 870, 1365, 889, 412, 862, 1369, 1090, 305, 163, 411, 466, 105, 1273, 788, 419, 1035, 170, 384, 1344, 1345, 247, 481, 827, 212, 317, 318, 316, 1030, 1178, 1131, 675, 1358, 256, 336, 1322, 623, 1130, 1172, 892, 588, 291, 1257, 743, 408, 286, 1H071046, 1162, 70, 1323, 1325, 260, 106, 83, 876, 211, 655, 568, 198, 268, 495, 974, 793, 160, 907, 486, 1251, 469, 669;
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722067; UDI: 00884838085350; System Serial Number: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225, 69, 214, 41, 98, 81, 123, 278, 46, 277, 115, 150, 163, 131, 71, 104, 132, 147, 208, 244, 75, 36, 234, 141, 70, 26, 148, 133, 57, 128, 188, 151, 68, 233, 111, 255, 43, 33, 22, 146, 256, 270, 238, 187, 74, 154, 157, 251, 237, 222, 95, 53, 262, 29, 59, 209, 260, 191, 274, 52, 107, 218, 169, 231, 142, 143, 144, 275, 127, 210, 211, 212, 213, 206, 30, 23, 265, 190, 268, 203, 138, 34, 113, 254, 140, 266, 60, 97, 45, 112, 134, 100, 101, 168, 235, 272, 58, 47, 273, 176, 64, 156, 276, 232, 54, 55, 165, 25, 271, 35, 202, 149, 243, 32, 224, 207, 76, 108, 226, 48, 264, 102, 84, 105, 99, 21, 159, 49, 185, 51, 239, 40, 94, 63, 96, 129, 245, 186, 130, 252, 161, 120, 170, 195, 196, 197, 171, 200, 193, 80, 28, 229, 145, 79, 93, 137, 50, 44, 38, 175, 227, 167, 78, 86, 91, 189, 198, 37, 72, 199, 88, 27, 121, 179, 183, 117, 118, 85, 89, 90, 119, 87, 31, 110, 178, 73, 194, 39, 56, 139, 61; (2) System Code: 722225; UDI: 00884838099265; System Serial Number: 104, 153, 46, 28, 72, 208, 41, 122, 147, 376, 262, 331, 112, 110, 207, 375, 404, 405, 68, 177, 291, 299, 400, 29, 141, 216, 217, 71, 37, 175, 205, 228, 229, 157, 340, 453, 53, 259, 260, 300, 268, 55, 235, 298, 233, 354, 289, 148, 249, 434, 435, 409, 84, 111, 227, 455, 365, 284, 362, 468, 56, 232, 230, 269, 345, 296, 462, 374, 246, 324, 128, 241, 180, 367, 431, 287, 450, 460, 152, 292, 145, 124, 475, 306, 469, 470, 437, 248, 338, 140, 465, 413, 457, 314, 83, 414, 433, 461, 426, 420, 421, 422, 168, 158, 290, 267, 454, 418, 386, 309, 310, 438, 257, 223, 366, 173, 43, 8, 146, 276, 301, 109, 5, 189, 200, 387, 451, 452, 364, 65, 66, 398, 196, 372, 293, 315, 254, 312, 343, 201, 320, 392, 38, 423, 14, 350, 243, 393, 373, 99, 206, 456, 4, 442, 327, 447, 96, 47, 48, 52, 446, 302, 195, 186, 448, 242, 167, 187, 255, 256, 385, 30, 384, 321, 459, 169, 134, 135, 79, 103, 214, 395, 427, 116, 439, 107, 477, 133, 313, 346, 476, 471, 472, 251, 253, 441, 326, 411, 368, 333, 252, 351, 283, 87, 349, 1, 123, 220, 184, 258, 237, 234, 218, 149, 231, 342, 396, 7, 159, 142, 144, 274, 178, 348, 17, 31, 226, 330, 114, 266, 219, 20, 32, 155, 121, 192, 117, 164, 82, 85, 194, 131, 132, 355, 222, 40, 353, 212, 106, 445, 370, 44, 317, 13, 430, 213, 54, 244, 245, 69, 319, 64, 165, 166, 224, 334, 18, 19, 77, 76, 280, 236, 161, 311, 10, 316, 150, 119, 88, 125, 190, 151, 281, 75, 211, 39, 127, 369, 60, 272, 193, 118, 341, 210, 86, 170, 171, 61, 332, 361, 115, 307, 221, 198, 35, 59, 36, 363, 154, 15, 62, 57, 335, 279, 191, 160, 275, 94, 95, 23, 139, 197, 402, 11, 391, 120, 58, 34, 21, 329, 322, 67, 278, 162, 89, 90, 92, 337, 91, 137, 108, 73, 93, 371, 179, 360, 143, 359, 303, 163, 286, 432, 379, 138, 325, 100, 247, 98, 16, 27, 80, 282, 42, 105, 377, 424, 74, 277, 63, 323, 240, 70, 12, 9, 204, 238; (3) System Code: 722235; UDI: 00884838116788; System Serial Number: 77, 127, 76, 88, 12, 43, 102, 59, 71, 11, 55, 57, 89, 13, 74, 105, 118, 125, 135, 41, 94, 70, 54, 72, 47, 4, 92, 139, 79, 93, 27, 78, 14, 20, 109, 108, 56, 106, 30, 31, 142, 107, 10, 3, 99, 137, 131, 82, 83, 84, 100, 126, 66, 67, 96, 63, 34, 28, 17, 18, 65, 40, 45, 44, 42, 52, 49, 101, 53, 48, 81, 103, 25, 24, 6, 38, 39, 7, 5, 22, 8, 110, 58, 111, 98, 138, 64, 9, 35, 19, 23, 21, 33;
Apr 8, 2026
View details →Cardinal health 200, llc
High PriorityActive
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X
Apr 8, 2026
View details →Synthes (usa) products llc
High PriorityActive
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Allura Xper FD10C; System Code: 722001;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
System Code: 722001; UDI: N/A; System Serial Number: 19, 249, 21, 18661014, 77, 82, 195, 216, 337, 37, 258, 283, 15, 256, 305;
Apr 8, 2026
View details →Recor medical inc.
High PriorityActive
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 700G Insulin pump: 763000552541, 763000541323, 763000854737, 763000854720: MINIMEDTM 700 INSULIN PUMP USER GUIDE mmol/L(M984972A021 1); MINIMED 700 INSULIN PUMP USER GUIDE mg/dL(M015850C001 1).
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722079; UDI: 00884838085268; System Serial Number: 1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307, 703904, 1048, 1137, 401, 1010, 1054, 266, 534, 535, 536, 818, 412, 617, 246, 488, 53, 57, 905, 55, 691, 992, 809, 848, 1033, 836, 891, 1155, 466, 1157, 1395, 703559, 263, 420, 703391, 673, 297, 298, 299, 564, 838, 1032, 1117, 987, 1310, 1211, 1213, 47, 1365, 1408, 881, 774, 856, 922, 58, 471, 1012, 755, 633, 703540, 296, 703558, 574, 703336, 842, 884, 991, 753, 703493, 1086, 790, 840, 407, 408, 481, 703350, 877, 703395, 703323, 703775, 590, 709, 710, 711, 713, 716, 1216, 483, 1098, 1392, 241, 703408, 1108, 1363, 1355, 1414, 703387, 703404, 863, 350, 528, 703465, 1380, 908, 1238, 1378, 262, 598, 858, 859, 275, 703861, 520, 335, 1018, 593, 911, 480, 1410, 703329, 213, 325, 496, 887, 903, 703413, 1432, 594, 1309, 1312, 999, 1424, 465, 674, 1084, 353, 499, 1230, 813, 703508, 33, 1346, 1189, 1401, 361, 267, 403, 439, 526, 1021, 736, 1370, 608, 68, 703324, 611, 413, 414, 415, 453, 703306, 895, 703615, 587, 1297, 1399, 428, 883, 1267, 422, 758, 1040, 634, 573, 714, 274, 525, 843, 885, 1276, 1102, 703478, 1142, 792, 919, 703528, 754, 599, 1171, 1096, 1097, 766, 817, 78, 703419, 1322, 878, 1170, 1107, 703435, 703310, 944, 654, 703521, 273, 703305, 715, 703495, 1285, 854, 19, 904, 1005, 804, 703497, 730, 1400, 954, 375, 957, 697, 703332, 658, 423, 1022, 896, 897, 1411, 1430, 621, 703426, 628, 795, 272, 1007, 940, 250, 46, 1289, 605, 65, 360, 468, 472, 469, 828, 737, 925, 32, 857, 703416, 703327, 34, 1222, 1268, 1063, 703335, 769, 938, 655, 229, 738, 1204, 1311, 572, 776, 538, 797, 989, 946, 888, 393, 394, 1062, 52, 703396, 703420, 281, 939, 703407, 1219, 955, 402, 1042, 867, 868, 909, 931, 703425, 374, 459, 1282, 841, 703532, 1436, 703344, 1358, 1359, 1360, 1391, 703389, 50, 1006, 1352, 580, 581, 703309, 703383, 703510, 974, 1245, 396, 860, 326, 741, 584, 721, 216, 899, 703, 927, 928, 923, 981, 865, 1163, 416, 268, 689, 717, 497, 900, 1369, 424, 1258, 1323, 959, 447, 448, 1385, 1386, 852, 1252, 802, 915, 703379, 703402, 751, 704281, 436, 703311, 1402, 910, 866, 703418, 1242, 354, 708, 251, 703501, 1064, 1156, 1049, 342, 343, 344, 345, 1271, 631, 18, 479, 1103, 1361, 577, 1041, 1423, 29, 1043, 1270, 1250, 805, 930, 1200, 228, 30, 366, 543, 588, 355, 356, 357, 358, 359, 1090, 445, 703314, 945, 1226, 1232, 1236, 1237, 853, 801, 1187, 222, 247, 474, 62, 70, 703450, 537, 48, 351, 777, 41, 898, 703317, 653, 684, 703334, 912, 746, 703368, 703562, 54, 1231, 731, 540, 998, 618, 1179, 703360, 1283, 668, 1431, 607, 706, 847, 879, 703308, 837, 1251, 703575, 387, 417, 1316, 45, 1393, 1290, 334, 320, 429, 212, 290, 703409, 239, 669, 703390, 629, 1078, 800, 56, 703584, 470, 595, 64, 671, 793, 1059, 1381, 1382, 747, 585, 1246, 663, 1212, 703333, 1274, 255, 455, 637, 862, 1379, 1235, 810, 1164, 227, 437, 438, 703345, 990, 314, 613, 427, 60, 1100, 703486, 602, 318, 937, 703515, 703455, 703456, 703457, 942, 948, 1201, 1247, 702, 333, 703388, 644, 845, 846, 1415, 1000, 814, 284, 352, 703356, 703380, 703381, 265, 679, 328, 329, 330, 331, 332, 1017, 1039, 1374, 750, 1016, 783, 703550, 703685, 703551, 703813, 704301, 780, 703719, 217, 476, 815, 816, 214, 703565, 1280, 704304, 561, 59, 703338, 719, 894, 744, 745, 704059, 729, 943, 302, 31, 337, 703552, 703613, 704240, 704242, 703662, 1340, 549, 703838, 1037, 703823, 703670, 1026, 377, 379, 380, 1405, 258, 259, 260, 395, 433, 451, 662, 703355, 703449, 703654, 703699, 703870, 703612, 704299, 704300, 703899, 1306, 970, 1248, 822, 449, 1047, 1019, 1241, 557, 1143, 752, 704129, 558, 947, 1190, 1196, 1172, 1319, 703712, 1397, 1398, 289, 704295, 994, 703326, 703655, 703702, 703939, 531, 703802, 703897, 704203, 704266, 1389, 703953, 703986, 703600, 570, 703769, 458, 962, 703374, 703710, 704026, 703592, 215, 703384, 703392, 545, 703753, 703967, 704112, 984, 703992, 703807, 1036, 1351, 703463, 703818, 871, 703529, 1073, 704154, 778, 548, 798, 704037, 933, 316, 703669, 704290, 234, 1429, 313, 49, 704209, 722, 703619, 704142, 378, 418, 1053, 600, 825, 452, 969, 1020, 1265, 763, 703545, 703358, 1095, 703487, 704092, 461, 1239, 703867, 786, 578, 703572, 559, 560, 982, 703462, 464, 703583, 1106, 1044, 703855, 704127, 1205, 1206, 1214, 450, 703348, 252, 703872, 430, 997, 271, 312, 1338, 855, 1169, 1030, 1120, 339, 1121, 934, 1168, 1150, 699, 704199, 703489, 703959, 913, 563, 304, 1191, 567, 566, 916, 388, 707, 1195, 1193, 301, 554, 555, 704282, 704284, 1083, 703966, 303, 305, 704101, 1194, 785, 703961, 1337, 993, 688, 347, 772, 74, 632, 383, 735, 39, 1074, 230, 1182, 1341, 293, 936, 703944, 704258, 295, 675, 949, 411, 701, 287, 286, 232, 760, 421, 726, 1109, 1144, 434, 591, 61, 961, 1072, 1185, 703477, 257, 661, 704146, 703982, 1440, 1441, 1442, 389, 703438, 703783, 704211, 703812, 1122, 725, 703423, 341, 367, 37, 1317, 1192, 1264, 575, 1202, 36, 309, 67, 703824, 1278, 703313, 703544, 703393, 703428, 703713, 703815, 1372, 703330, 1347, 958, 703472, 951, 1009, 482, 1254, 300, 620, 986, 703740, 493, 484, 988, 1082, 704171, 542, 703470, 589, 552, 704277, 235, 486, 700, 348, 565, 322, 1123, 819, 703749, 782, 25, 1154, 703965, 703993, 704239, 703877, 703542, 1001, 704173, 71, 703445, 551, 550, 703526, 1186, 1104, 740, 704085, 704079, 703485, 547, 703500, 703935, 371, 835, 703436, 1203, 485, 703405, 704289, 596, 803, 703806, 1052, 703804, 703906, 703596, 1181, 224, 703937, 703972, 1288, 703954, 1183, 1217, 368, 1314, 703650, 704262, 703948, 703556, 687, 902, 1422, 571, 278, 457, 703754, 704081, 703854, 704103, 1116, 478, 682, 704019, 703995, 1119, 960, 824, 1257, 522, 523, 839, 703424, 704023, 704119, 1015, 703614, 1089, 1175, 748, 781, 1076, 1129, 532, 703347, 1166, 704030, 704126, 489, 956, 569, 432, 874, 703819, 704036, 889, 446, 914, 703690, 703597, 703866, 703611, 1080, 703375, 704269, 703648, 703709, 787, 703586, 704207, 703728, 703826, 381, 630, 638, 826, 901, 703607, 703574, 1165, 762, 703743, 703632, 703913, 703889, 703700, 704246, 704054, 703606, 703473, 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487, 703363, 500, 980, 703452, 463, 26, 541, 893, 1145, 373, 294, 703999, 635, 768, 929, 609; (2) System Code: 722224; UDI: 00884838099258; System Serial Number: 1229, 450, 1576, 1577, 1578, 750, 409, 261, 262, 272, 275, 277, 295, 630, 1003, 1315, 2744, 3526, 381, 959, 232, 1019, 1371, 260, 1049, 1484, 2258, 3044, 3045, 3107, 2573, 1083, 3514, 3314, 2184, 2436, 246, 475, 1810, 762, 3153, 526, 2241, 588, 469, 962, 539, 421, 288, 90, 1635, 2784, 50, 239, 2520, 589, 91, 1556, 2945, 840, 362, 43, 1869, 1564, 1692, 2778, 210, 44, 2421, 2432, 287, 2882, 3291, 3155, 3211, 904, 403, 1356, 1955, 1808, 2800, 2801, 1838, 2368, 951, 723, 216, 3697, 1874, 1150, 3062, 3063, 226, 2881, 790, 3042, 2434, 3374, 1266, 365, 266, 512, 954, 301, 1046, 1081, 1103, 993, 994, 958, 901, 3067, 514, 553, 2390, 832, 1569, 1636, 617, 618, 82, 753, 754, 40, 2227, 2280, 2879, 369, 1781, 1929, 3642, 2376, 527, 2972, 1025, 110, 1938, 297, 3244, 1300, 2765, 2786, 3393, 3336, 584, 1362, 1255, 1259, 859, 2971, 957, 425, 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3362, 105, 2901, 291, 444, 817, 2058, 640, 298, 2980, 240, 1516, 876, 94, 564, 33, 856, 1245, 385, 2524, 2532, 2503, 3376, 715, 1047, 461, 2135, 41, 577, 129, 2969, 432, 439, 603, 2449, 1038, 595, 792, 2979, 3007, 713, 741, 401, 2595, 400, 3373, 415, 1317, 3398, 963, 965, 1228, 2308, 1265, 2995, 3120, 3123, 3179, 1510, 178, 494, 1662, 2316, 571, 2619, 2620, 151, 554, 1574, 892, 1174, 657, 115, 274, 3145, 3146, 1357, 215, 674, 1086, 1093, 1279, 1329, 3038, 342, 282, 1554, 865, 138, 478, 516, 770, 187, 871, 873, 49, 154, 1482, 1783, 2229, 2246, 2247, 2248, 278, 2764, 433, 1168, 2727, 3525, 2522, 2523, 1175, 1395, 552, 964, 1571, 624, 354, 885, 189, 1994, 1100, 217, 2839, 192, 3130, 2502, 755, 3210, 3486, 3603, 108, 1278, 373, 2154, 339, 471, 103, 947, 1140, 825, 1519, 234, 47, 1615, 1637, 1651, 1657, 1925, 665, 637, 2846, 1264, 3341, 1606, 1612, 1613, 3219, 3337, 338, 3541, 1490, 2569, 128, 1101, 1118, 2974, 3588, 1012, 1467, 2913, 265, 1158, 2435, 1960, 2045, 119, 446, 483, 484, 696, 2860, 1252, 869, 1376, 1377, 1514, 1550, 2185, 3023, 2900, 587, 1985, 3178, 1839, 2740, 436, 438, 608, 2140, 2141, 112, 2548, 1257, 1037, 1739, 464, 335, 841, 326, 134, 3515, 453, 893, 1540, 507, 2675, 147, 148, 1565, 447, 107, 2754, 1018, 2377, 1879, 1004, 1214, 417, 374, 396, 482, 730, 1486, 3016, 2572, 1405, 163, 1230, 492, 233, 1935, 2226, 3492, 2567, 2332, 2533, 3132, 3147, 583, 3269, 662, 836, 78, 1663, 267, 268, 346, 1555, 2239, 1276, 3384, 443, 1782, 2439, 2452, 252, 3224, 2281, 3090, 1436, 1653, 2609, 1525, 2718, 1246, 1256, 414, 797, 1014, 2370, 1866, 953, 763, 1563, 45, 2326, 543, 1244, 2195, 2196, 3085, 651, 1459, 285, 308, 540, 351, 1024, 2221, 1394, 1381, 2717, 1111, 2453, 2501, 3509, 300, 100, 591, 140, 1309, 1310, 2172, 2720, 952, 479, 2647, 735, 2279, 616, 2132, 1079, 2220, 594, 857, 973, 2579, 1526, 3165, 370, 437, 599, 1702, 3328, 3333, 3274, 251, 2859, 3615, 2228, 3172, 1956, 2869, 2939, 1299, 124, 125, 120, 183, 2222, 366, 2737, 1041, 131, 3258, 839, 2278, 39, 999, 785, 2072, 982, 1221, 2617, 945, 3207, 1798, 3039, 1873, 1142, 88, 1215, 466, 101, 1147, 1954, 462, 2729, 3303, 99, 3516, 2143, 3176, 2963, 592, 3101, 3415, 2970, 2655, 188, 986, 106, 472, 2663, 3577, 2369, 1483, 36, 626, 2301, 312, 2130, 165, 1551, 3037, 1793, 1363, 1364, 3078, 72, 2139, 141, 956, 2152, 2876, 3539, 1383, 3026, 2965, 2967, 1999, 2000, 2001, 2425, 28, 3444, 1872, 2199, 2144, 2148, 46, 777, 177, 440, 1460, 1611, 1274, 1301, 884, 2564, 364, 746, 2340, 3161, 2403, 80, 574, 2198, 3270, 113, 644, 169, 2328, 1797, 2138, 250, 1507, 1509, 1458, 3052, 3053, 435, 3087, 1403, 194, 53, 1828, 1829, 1830, 2961, 606, 2417, 900, 332, 2636, 3414, 2427, 517, 2219, 1354, 845, 847, 2131, 254, 102, 843, 3579, 1061, 1499, 1250, 3205, 3690, 960, 290, 1336, 404, 1444, 1517, 2903, 2907, 485, 621, 622, 2288, 331, 467, 468, 3106, 974, 465, 1233, 1240, 1235, 328, 329, 139, 159, 1461, 1508, 1511, 1512, 490, 593, 3593, 2325, 2327, 1455, 2957, 279, 955, 2027, 3614, 253, 1161, 1243, 905, 3419, 3448, 2367, 1324, 2374, 307, 1959, 888, 3483, 1493, 64, 130, 1112, 1650, 3352, 2682, 116, 1689, 2669, 3157, 1251, 3454, 3527, 3668, 3489, 607, 2437, 2928, 844, 975, 1060, 2426, 327, 1775, 1776, 3189, 2018, 740, 747, 851, 852, 1547, 979, 862, 897, 3471, 3528, 3530, 3531, 787, 2919, 176, 2149, 2197, 418, 219, 1998, 1091, 1491, 1409, 582, 441, 84, 3664, 798, 823, 824, 2506, 949, 174, 2926, 350, 1468, 3673, 940, 271, 76, 1170, 3573, 761, 109, 1288, 1982, 160, 34, 786, 2494, 2699, 1000, 2557, 793, 1353, 3388, 581, 1827, 2150, 220, 2681, 225, 235, 714, 2518, 2519, 452, 1213, 1126, 2156, 766, 1254, 518, 522, 523, 726, 1311, 1314, 3299, 2770, 3401, 3049, 2030, 1316, 343, 1410, 2733, 643, 3369, 3082, 3164, 1527, 104, 1201, 503, 659, 1015, 1335, 185, 1231, 196, 944, 2752, 1247, 833, 1029, 258, 2843, 330, 172, 372, 2955, 1477, 379, 666, 585, 722, 1156, 3650, 3661, 3662, 3692, 649, 874, 875, 3596, 1787, 480, 495, 2242, 173, 2667, 1478, 2029, 3505, 3459, 2772, 2937, 1863, 780, 1622, 1089, 1341, 257, 352, 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1232, 3142, 1332, 236, 1105, 416, 2460, 2530, 1205, 1355, 1676, 2845, 1761, 1360, 1180, 2468, 1633, 3554, 3234, 85, 2983, 872, 985, 59, 898, 2446, 371, 1864, 3268, 3141, 647, 3366, 2589, 156, 1182, 1017, 1809, 2678, 347, 2345, 1420, 1948, 1590, 2017, 2590, 1660, 2844, 2710, 3540, 3558, 1523, 1434, 991, 569, 2816, 2312, 3563, 4, 533, 270, 3667, 3557, 2296, 2204, 2402, 3424, 1673, 2351, 2356, 2357, 3523, 1986, 1665, 1824, 1655, 3263, 3716, 3317, 2887, 3612, 3586, 2061, 1927, 2904, 1553, 3109, 2380, 1413, 1127, 2123, 3437, 1732, 1193, 1771, 3240, 3241, 3737, 2791, 1788, 2632, 1500, 3436, 2334, 3583, 2956, 3226, 3633, 3635, 1198, 2660, 3517, 1819, 1440, 1285, 1178, 2650, 1607, 1418, 2471, 3115, 1631, 2115, 2875, 2666, 2212, 1599, 2634, 1389, 2274, 1457, 1489, 1624, 2085, 1497, 1946, 3551, 1971, 1990, 3687, 3002, 1445, 2796, 2024, 3056, 3645, 2225, 2702, 1674, 2282, 2408, 3102, 3140, 2822, 1941, 2607, 1825, 3128, 1520, 2387, 2388, 1696, 1708, 2894, 3626, 2019, 2020, 3103, 3054, 1729, 3599, 3080, 2821, 3601, 2407, 1548, 2116, 1979, 2491, 2492, 2773, 2774, 2664, 1202, 2372, 1836, 2213, 3041, 1416, 1754, 2333, 2040, 1658, 2169, 1756, 1152, 3430, 3611, 3058, 2726, 3421, 3663, 3254, 3434, 2761, 2762, 2763, 2807, 2808, 1384, 2173, 1641, 1822, 3110, 1291, 1442, 3186, 3683, 1532, 2695, 2118, 2337, 2338, 2823, 2825, 1749, 1439, 2639, 1130, 2766, 1992, 1790, 3773, 1195, 2249, 2890, 2469, 2065, 2067, 1752, 1755, 2826, 2677, 2382, 2785, 1438, 3689, 1996, 1844, 1848, 1989, 1841, 2059, 1121, 3625, 3731, 772, 773, 1950, 2295, 2381, 3432, 2683, 3703, 3710, 2092, 2023, 2053, 1166, 1070, 2114, 3743, 3744, 2200, 3686, 1849, 2428, 1503, 3695, 1846, 1847, 3024, 3585, 2497, 2313, 2470, 1983, 2379, 2934, 3780, 1448, 2066, 1972, 2755, 3494, 1630, 2543, 2292, 1746, 2992, 3566, 3402, 3114, 1675, 2256, 1843, 2158, 2798, 1135, 1415, 2113, 1293, 2117, 1390, 2824, 2701, 3702, 1123, 2236, 2815, 2794, 3427, 3693, 1744, 3243, 2461, 2110, 2610, 1818, 2041, 2304, 2393, 3609, 2694, 1833, 2090, 2463, 2601, 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570, 918, 1951, 535, 536, 1928, 457, 2022, 213, 3097, 2366, 2232, 2475, 1023, 976, 2214, 1767, 3349, 2537, 928, 2054, 1592, 2167, 2833, 2161, 749, 2612, 1751, 3221, 1501, 1845, 1528, 2455, 2553, 984, 2078, 863, 3746, 2698, 712, 549, 1765, 2323, 3327, 70, 2849, 405, 3394, 2554, 2290, 1290, 2422, 3368, 781, 1683, 1741, 2935, 3139, 2757, 1823, 3730, 3222, 389, 390, 1131, 2008, 1852, 2207, 382, 3739, 2112, 1859, 1412, 2371, 855, 853, 1722, 724, 810, 2886, 1431, 1373, 1480, 3749, 688, 1227, 1022, 697, 2006, 699, 2440, 992, 1428, 700, 2100, 2209, 701, 1242, 2517, 3491, 2342, 743, 3763, 751, 2389, 689, 2909, 1207, 3396, 705, 1021, 1176, 1465, 759, 2119, 698, 760, 1087, 703, 704, 1068, 1407, 3682, 1496, 1552, 2622, 1792, 691, 3709, 477, 2991, 556, 721, 677, 2083, 2068, 1157, 769, 3242, 280, 646, 168, 384, 3185, 917, 1505, 61, 392, 654, 568, 676, 562, 487, 1973, 96, 142, 397, 1718, 914, 3239, 2642, 3719, 137, 3679, 2075, 388, 969, 1430, 2988, 2834, 1134, 3620, 473, 1471, 794, 197, 143, 2614, 2042, 1211, 692, 2413, 1065, 1177, 1006, 2896, 1582, 2062, 150, 557, 2558, 1723, 3451, 1400, 764, 2035, 2036, 910, 3765, 2521, 1187, 2657, 1421, 2626, 2832, 83, 157, 170, 1515, 718, 455, 2973, 2315, 1646, 731, 879, 889, 3217, 809, 3589, 118, 2802, 212, 144, 538; (3) System Code: 722234; UDI: 00884838116771; System Serial Number: 163, 327, 780, 362, 502, 222, 803, 347, 161, 84, 352, 287, 212, 322, 88, 716, 185, 426, 292, 43, 252, 59, 60, 332, 97, 359, 346, 383, 300, 804, 340, 711, 186, 99, 413, 547, 449, 335, 437, 813, 447, 358, 510, 511, 404, 484, 626, 216, 207, 248, 175, 87, 333, 395, 55, 68, 655, 459, 71, 465, 274, 330, 501, 535, 463, 320, 218, 817, 483, 516, 616, 461, 475, 270, 762, 617, 178, 171, 198, 331, 123, 124, 726, 162, 774, 85, 284, 67, 94, 469, 696, 471, 607, 606, 758, 260, 619, 267, 269, 489, 255, 628, 629, 730, 637, 639, 640, 633, 92, 345, 874, 257, 101, 493, 772, 560, 168, 79, 155, 372, 714, 797, 794, 565, 225, 286, 657, 585, 638, 779, 233, 620, 432, 433, 208, 435, 309, 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544, 504, 468, 645, 448, 399, 523, 51, 612, 181, 182, 579, 96, 235, 236, 237, 953, 1022, 506, 933, 310, 634, 414, 487, 495, 400, 876, 95, 754, 481, 313, 277, 278, 983, 497, 498, 508, 782, 792, 826, 39, 337, 250, 281, 195, 491, 21, 776, 341, 614, 763, 631, 589, 692, 775, 242, 820, 658, 759, 627, 490, 687, 137, 138, 314, 635, 308, 41, 245, 149, 65, 665, 721, 38, 145, 1017, 651, 445, 650, 17, 743, 355, 881, 305, 148, 572, 727, 443, 12, 13, 819, 452, 254, 49, 328, 649, 105, 73, 23, 596, 611, 446, 731, 677, 837, 115, 338, 571, 439, 219, 384, 44, 132, 713, 478, 479, 480, 378, 406, 19, 724, 604, 241, 57, 742, 135, 374, 505, 303, 387, 388, 142, 802, 58, 474, 339, 239, 247, 531, 249, 364, 365, 127, 569, 47, 229, 360, 361, 425, 950, 52, 294, 840, 766, 844, 189, 18, 312, 156, 301, 152, 279, 197, 33, 871, 184, 32, 20, 31, 909, 26, 563, 29, 870, 272, 553, 746, 736, 856; (4) System Code: 722282; UDI: 00884838110571; System Serial Number: 57, 54, 66, 73, 32, 7, 87, 55, 36, 110, 111, 112, 45, 116, 59, 81, 89, 42, 47, 48, 31, 26, 63, 83, 99, 46, 91, 39, 40, 34, 84, 114, 43, 44, 76, 28, 95, 115, 131, 9, 101, 16, 17, 51, 79, 56, 30, 121, 97, 41, 20, 33, 77, 68, 65, 98, 70, 11, 88, 126, 71, 94, 105, 24, 29, 38, 122, 25, 10, 93, 75, 113, 18, 104, 72, 21, 35, 85, 64, 69, 8, 62, 80, 82, 124, 23, 52, 53, 15, 100, 50;
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
MEDLINE ANTERIOR HIP PACK DYNJ64672B
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
UDI-DI 10195327377496 (EA) 40195327377497 (CS) LOT 23LMD300
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Vue Motion V12. Product Number: 1017979.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
Product Number: 1017979, Software Version: v12.2.0 - v12.2.8.500. UDI Numbers: (01)00884838100367(11)200221(10)12.2.5, (01)00884838100367(11)230223(10)12.2.8.300, (01)00884838100343(11)200423(10)12.2.5.0, (01)00884838100367(11)230615(10)12.2.8.310, (01)00884838100367(11)200903(10)12.2.5.1, (01)00884838100367(11)230720(10)12.2.8.400, (01)00884838100343(11)201125(10)12.2.5.100, (01)00884838100367(11)230921(10)12.2.8.410, (01)00884838100343(11)210217(10)12.2.5.200, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100367(11)210628(10)12.2.5.300, (01)00884838100350(11)240116(10)12.2.8.421, (01)00884838100367(11)210628(10)12.2.5.300, (01)00884838100350(11)240204(10)12.2.8.422, (01)00884838100343(11)220525(10)12.2.5.400, (01)00884838100350(11)240226(10)12.2.8.424, (01)00884838100367(11)230223(10)12.2.5.405, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100336(11)230301(10)12.2.5.406, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100367(11)230320(10)12.2.5.407, (01)00884838100336(11)231221(10)12.2.8.420, (01)00884838100367(11)230403(10)12.2.5.408, (01)00884838100367#(11)231223(10)12.2.8.435, (01)00884838100343(11)240211(10)12.2.5.413,(01)00884838100367#(11)231228(10)12.2.8.435A, (01)00884838100343(11)20240923(10)12.2.5.414, (01)00884838100343(11)240917(10)12.2.8.436, (01)00884838100343(11)250728(10)12.2.5.416, (01)00884838100367(11)241014(10)12.2.8.437, (01)00884838100367(11)210308(10)12.2.8.0, (01)00884838100343(11)241128(10)12.2.8.438, (01)00884838100367(11)220127(10)12.2.8.100, (01)00884838100367(11)250122(10)12.2.8.439, (01)00884838100343(11)220417(10)12.2.8.130, (01)00884838100350(11)240407(10)12.2.8.440, (01)00884838100350(11)221213(10)12.2.8.200, (01)00884838100367(11)210308(10)12.2.8.0, (01)00884838100350(11)230301(10)12.2.8.210, (01)00884838100367(11)240616(10)12.2.8.500. Equipment Number: 86183662, 118470289, 115532146, 115483951, 117699552, 86093591, 98297412, 86093647, 86241626, 86093616, 119288183, 86241420, 86326303, 86325905, 86325795, 86325794, 86325747, 86325221, 86093571, 108816071, 86093582, 86093358, 86093539, 86241707, 86241692, 86093595, 86241861, 86241751, 86241678, 86324616, 116468394, 106682968, 86241742, 87750382, 108664430, 118757545, 87751135, 87750882, 86325445, 86241699, 86241684, 86241669, 86241750, 86093376, 89412152, 86093502, 86369383, 86093605, 120505331, 86093623, 86093339, 86093663, 86093678, 86367969, 104418433, 86325612, 86093588, 86093356, 86324563, 86093674, 86093646, 86093566, 86093685, 86093659, 118007768, 107808460, 119061786, 86093547, 88168079, 86326302, 86325187, 86325123, 86093545, 86093435, 86093427, 95752135, 94477265, 92029774, 92029787, 87771660, 117645555, 117645550, 86241704, 86241689, 86241674, 107639091, 112190786, 112190691, 86093283, 106771488, 110432369, 110432367, 106771482, 119091432, 119091431, 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Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: BATB; UDI-DI (Product Code): 00197513011941 (BATC18-R8BATB-2XF ), 00197513011941 (BATC18-R8BATB-3XF ), 00197513011941 (BATC8-R8BATB-LF ), 00197513011941 (BATC8-R8BATB-LM ), 00197513011941 (BATC8-R8BATB-MF ), 00197513011941 (BATC8-R8BATB-MM ), 00197513011941 (BATC8-R8BATB-PLUS ), 00197513011941 (BATC8-R8BATB-SF ), 00197513011941 (BATC8-R8BATB-XLF ), 00197513011941 (BATC8-R8BATB-XLM ), 00197513011941 (BATC8-R8BATB-XSF ). 2. Model Number: BATH; UDI-DI (Product Code): 00197513011934 (BATC18-R8BATH-2XF ), 00197513011934 (BATC18-R8BATH-2XM ), 00197513011934 (BATC18-R8BATH-3XF ), 00197513011934 (BATC18-R8BATH-3XM ), 00197513011934 (BATC8-R8BATH-LF ), 00197513011934 (BATC8-R8BATH-LM ), 00197513011934 (BATC8-R8BATH-MF ), 00197513011934 (BATC8-R8BATH-MM ), 00197513011934 (BATC8-R8BATH-PLUS ), 00197513011934 (BATC8-R8BATH-SF ), 00197513011934 (BATC8-R8BATH-SM ), 00197513011934 (BATC8-R8BATH-XLF ), 00197513011934 (BATC8-R8BATH-XLM ), 00197513011934 (BATC8-R8BATH-XSF ), 00197513011934 (BATC8-R8BATH-XLF ). 3. Model Number: BATM; UDI-DI (Product Code): 00197513011927 (BATC18-R8BATM-2XF ), 00197513011927 (BATC18-R8BATM-2XM ), 00197513011927 (BATC18-R8BATM-3XF ), 00197513011927 (BATC18-R8BATM-3XM ), 00197513011927 (BATC8-R8BATM-LF ), 00197513011927 (BATC8-R8BATM-LM ), 00197513011927 (BATC8-R8BATM-MF ), 00197513011927 (BATC8-R8BATM-MM ), 00197513011927 (BATC8-R8BATM-PLUS ), 00197513011927 (BATC8-R8BATM-SF ), 00197513011927 (BATC8-R8BATM-SM ), 00197513011927 (BATC8-R8BATM-XLF ), 00197513011927 (BATC8-R8BATM-XLM ), 00197513011927 (BATC8-R8BATM-XSF ), 00197513011927 (BATC8-R8BATM-XSM ).
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722006; UDI: N/A; System Serial Number: 1706, 1730, 1936, 2250, 518, 1260, 1831, 1095, 1096, 1370, 1564, 2269, 471, 1293, 1762, 1764, 225, 1832, 204, 1818, 778, 2587, 1092, 1273, 2274, 2569, 1425, 1496, 707, 1448, 1466, 2183, 1502, 2201, 920, 1654, 1707, 1206, 637, 1326, 2152, 637220, 2536, 861, 172, 529, 1711, 1201, 1363, 2027, 2187, 730, 616, 550, 2336, 1407, 1259, 1913, 674, 1477, 2454, 1081, 272, 2021, 1118, 2126, 771, 2574, 1740, CV.514, 283, 1323, 1604, 1366, 2606, 268, 2366, 1256, 1755, 2140, 599, 2161, 2612, 683, 1942, 1352, 1780, 2062, 852, 853, 95, 188, 968, 2577, 2585, 722008-358, 1932, 2066, 1139, 285, 1433, 822, 823, 1744, 1747, 1752, 1341, 1601, 269, 2548, 1420, 1328, 1922, 797, 2122, 929, 1827, 316, 1648, 2070, S01H006016/000001, 1439, 1659, 1093, 1886, 1854, 1888, 1587, 705, 2537, 121, 1237, 1490, 1441, 1518, 658, 1896, 141, 90, 384, 1523, 327, 606, 849, 2571, 215, 848, 904, 551, 1469, 1830, 289, 186, 2217, 1629, 1865, 588, 1391, 161, 2568, 886, 1346, 587, 2200, 2522, 535, 2323, 435, 1583, 1585, 1536, 1911, 1174, 1914, 826, 2296, 2608, 1560, 1761, 1550, 1844, 1848, 2045, 1589, 91, 2430, 753, 127, 2297, 1185, 504, 1843, 664, 2199, 1868, 1120, 1941, 2610, 595, 638, 1085, 18268, 723, 893, 2347, 1790, CV.740, 1209, 149, 2523, 1364, 2268, 211, 972, 661, 774, 1729, 1612, 1588, 2530, 1351, 1723, 2002, 1710, 2058, S4F621389A000001, 1872, 2042, 24, 992, 2380, 2525, 828, 91A, 2272, 353, 680, 1169, 1641, 37, 1627, 1338, 2562, 317, 331, 1807, 1476, 469, 1534, 889, 287, 1833, 1733, 2159, 1609, 679, 1731, 633056, 2088, 468, 2564, 187, 1661, 1578, 843, 1987, 2054, 702, 1235, 2143, 2051, 265, 1000, 1653, 167, 314, 2324, 1766, 1473, 2390, 1480, 1881, 2533, 1380, 2198, 168, 1318, 2823014, 2203, 1575, 2283, 1750, 1443, 2256, 780, 1507, 2009, 2195, 810, 1856, 1239, 372, 800, 1050, 1511, 1168, 1631, 1956, 722, 347, 2565, 1147, 553, 2135, 1774, 1446, 1908, 691, 2181, 1977, 1594, 2326, 2110, 1603, 166, 135, 2131, 731, 2425, 2106, 2111, 2112, 308, 2573, 2003, 226, 1978, 72246F, 1696, 52, 1242, 1211, 140, 1177, 1754, 521, 2382, 1890, 2281, 2097, 1600, 2427, 1274, 2147, 2607, 1611, 75289, 1900, 612, 2524, 295, CV.271, 913, 2184, 1637, 1582, 1921, 301, 1615, 1007, 1104, 1845, 641, 1927, 1928, 159, 2570, 1107, 2028, 1621, 1640, 1670, 1114, 1115, 1116, 1127, 1H041985, 1387, 1445, 120, 2462, 43074, 1939, 2301, 1734, 1383, 1046, 1361, 47, 1875, 1276, 234, 878, 315, 655, 914, 1277, 2456, 1302, 376, 767, 221, 1955, 1639, 207, 1727, 804, 2561, 781, 1227, 860, 830, 1289, 1306, 425, 343, 2158, 530, 2155, 2013, 1373, 1983, 2286, 1100, 1270, 1591, 2318, 1022, 1838, 1125, 1089, 511, 1307, 833, 1712, 1198, 812, 2392, 594, 794, 1741, 1349, 1454, 1455, 1456, 1751, 2053, 424, 1917, 1667, 2038, 1460, STOR_DEMO_17391651, 1401, 33, 1965, 2416, 1819, 902, 609, 492, 2104, 2348, 2423, 1925, 346, 1552, 1999, 1704, 2488, 1117, 1295, 2247, 1424, 717, 2137, 2278, 1222, 1253, 1947, 2293, 2079, 2124, 1687, 1129, 2529, 1791, 8, 2584, 2049, 2173, 808, 1158, 590, 2043, 1350, 1213, 994, 1859, 2304, 1692, 1264, 1524, 2528, 740, NA, 31, 2086, 941, 958, 2531, 2046, 2371, 1468, 1801, 2514, 768, 1316, 1075, 2551, 460, 2368, 1193, 1605, 2145, 2176, 1753, 1851, 578, 1708, 2175, 2129, 1317, 589, 1180, 1517, 2580, 687, 1652, 2154, 1203, 2342, 1557, 2527, 2550, 1884, 100079164-1971, 1580, 519, 600, 2373, 417, 2031, 1504, 491, 2179, 1784, 2061, 2538, 2428, 1602, 1542, NL94, 2214, 971, 1997, 1824, 859, 1021, 1802, 2085, 2103, 1452, 1808, 1533, 820, 2541, 462, 63, 2023, 2465, 2182, 2343, 2206, 2411, 1246, 1003, 1509, 659, 2526, 614, 2015, 1969, 866, 2194, 336, 2553, 880, 2555, 922, 1598, 1549, 2034, 689, 2114, 1494, 819, 2040, 2069, 2171, 1062, 1759, 585, 2219, 2228, 2259, 2063, 1823, 608, 1554, 1916, 2279, 2192, 1233, 1793, 1919, 2399, 854, 516, 2039, 1967, 867, 1513, 1031, 1817, 1505, 2288, 1991, 1347, 2292, 1948, 951, 2150, 2434, 1892, 1130, 1617, 955, 1961, 2144, 1344, 1988, 2064, 1284, 1529, 1814, 1515, 284, 1678, 428, 1815, 1463, 2244, 1891, 2305, 1336, 1004, 1106, 1787, 946, 952, 482, 455, 1763, 1985, 1899, 1777, 1968, 2438, 1650, 887, 1992, 2094, 811, 2041, 1840, 2360, 837, 2325, 856, 2022, 408, 2369, 1537, 1893, 1538, 380, 2115, 1715, 925, 2101, 1998, 2109, 1714, 2245, 2314, 2291, 1880, 1561, 873, 1746, 102, 2080, 2255, 2307, 2162, 1530, 2095, 1232, 1343, 1506, 2093, 1348, 704, 1849, 2361, 477, 2611, 1595, 164, 1492, 565, 2532, 1568, 2248, 2552, 2117, 125, , 1397, 1618, 1224, 636, 1949, 1192, 891, 1204, 885, 2010, 374, 1794, 724, 2231, 1876, 1686, 2393, 2334, 1858, 352, 2225, 1392, 1149, 89, 940, 931, 2310, 696, 233, 1658, 151, 963, 1749, 2275, 1408, 2353, 1551, 549, 2067, 2163, 1668, 2547, 1525, 2237, 2230, 259, PSO.6002064, 688, 831, 1690, 1250, 520, 1738, 1281, 1488, 2290, 617, 1056, 936, 581, 1540, 2379, 890, 1330, 2367, 2598, 457, 602, 2493, 1556, 640, 2209; (2) System Code: 722012; UDI: 00884838059054; System Serial Number: 481, 423, 1506, 1713, 1396, 2821, 828, 383, 2942, 2308, 1271, 613, 1945, 1281, 1188, 2323, 369, 160, 124, 848, 2265, 459, 469, 1120, 814, 815, 2610, 278, 297, 352, 511, 856, 560, 2522, 2735, 1645, 1407, 2924, 1608, 2707, 570, 1293, 424, 1047, 274, 2933, 135, 150, 2740, 336, 741, 1649, 2687, 655, 1192, 577, 578, 2203, 1036, 1063, 1209, 2254, 1357, 2835, 2843, 1854, 1084, 1027, 518, 888, 1672, 760, 859, 187, 1908, 1848, 735, 2149, 1923, 277, 1743, 1961, 731, 1724, 174, 1306, 1210, 1545, 1692, 1117, 651, 192, 923, 925, 2150, 2937, 1277, 2855, 2856, 2712, 1478, 1561, 2696, 1430, 1519, 2068, 2138, 2234, 1326, 1943, 1549, 1613, 2006, 2454, 606, 1126, 2721, 377, 758, 1868, 2313, 2658, 1335, 1461, 959, 1455, 2085, 1477, 695, 1336, 2171, 1542, 430, 115, 89, 213, 1119, 2161, 1723, 865, 531, 2202, 2828, 1515, 1285, 2219, 1118, 2269, 767, 1014, 601, 1035, 2286, 2293, 1034, 768, 1948, 670, 1207, 2898, 321, 990, 334, 893, 243, 974, 1656, 1108, 2607, 1166, 2134, 1599, 2929, 1141, 1218, 132, 1683, 684, 2288, 2920, 1002, 244, 319, 1975, 1735, 1408, 483, 484, 615, 1686, 505, 1583, 2305, 2302, 590, 756, 691, 1508, 616, 2896, 1305, 1406, 75, 733, 2722, 2726, 2086, 451, 625, 2883, 1032, 1746, 976, 2518, 1919, 205, 2755, 1714, 1798, 2741, 1104, 1560, 1327, 1301, 1003, 1610, 490, 1083, 310, 611, 1195, 208, 943, 1630, 2201, 1733, 1734, 1054, 1189, 2736, 790, 782, 562, 104, 1594, 971, 476, 1871, 2506, 1726, 2890, 579, 1249, 498, 2057, 2829, 610, 2512, 1586, 1265, 1446, 1344, 513, 67, 1625, 1675, 1307, 2307, 1316, 70, 1593, 2151, 924, 1732, 455, 1113, 66, 68, 2135, 855, 2656, 2292, 412, 1001, 963, 2629, 480, 2496, 320, 1224, 858, 2645, 107, 1447, 1688, 1091, 1254, 1405, 1832, 453, 99, 1456, 1993, 2014, 2022, 640, 2289, 2222, 444, 1212, 1964, 1354, 1918, 852, 442, 1345, 404, 649, 650, 1328, 302, 114, 86, 624, 1664, 1219, 2156, 1607, 76, 325, 1016, 224, 935, 2889, 2092, 1793, 1797, 2509, 1279, 1116, 1359, 2145, 2146, 2148, 2713, 2516, 2899, 2227, 2046, 2166, 464, 2221, 1317, 103, 2063, 2285, 1422, 1616, 1660, 399, 1869, 2857, 197, 2215, 2693, 1805, 234, 323, 2886, 100, 2609, 440, 1077, 2311, 589, 1595, 2939, 2469, 1657, 1537, 2875, 2888, 543, 123, 126, 136, 2614, 1078, 71, 2697, 1807, 1924, 1053, 418, 1148, 1181, 492, 1596, 2484, 948, 1673, 1329, 1803, 2873, 1075, 950, 1512, 1716, 2655, 639, 669, 671, 1922, 568, 2065, 326, 2840, 2841, 2849, 2842, 1947, 1950, 1216, 2901, 2310, 72, 2657, 740, 1652, 1099, 1804, 335, 1092, 597, 446, 2054, 85, 643, 920, 1533, 2774, 1033, 894, 88, 1441, 2723, 1992, 517, 1858, 1559, 566, 2900, 1611, 574, 316, 1796, 2508, 2511, 2892, 1250, 1356, 2015, 2207, 489, 766, 406, 1017, 1020, 1823, 527, 1115, 248, 846, 101, 1661, 952, 953, 954, 2514, 1211, 2309, 878, 1827, 851, 2515, 1037, 823, 1334, 2013, 986, 1960, 2677, 1516, 488, 1097, 1404, 2876, 2653, 676, 1852, 1906, 233, 239, 2881, 1044, 1022, 1023, 2264, 796, 1904, 2926, 2283, 525, 159, 2943, 1806, 1558, 1941, 2319, 594, 926, 1989, 2844, 666, 276, 1440, 1550, 2081, 2692, 2003, 2004, 1842, 331, 1712, 1073, 685, 2760, 542, 1690, 69, 533, 473, 2869, 2868, 1467, 1337, 1282, 718, 1662, 576, 595, 2521, 1570, 1946, 1026, 520, 1269, 2912, 1598, 1038, 1058, 1177, 1062, 1731, 787, 1294, 1324, 2276, 389, 732, 751, 1895, 1900, 1665, 1811, 1255, 797, 1894, 504, 757, 494, 1532, 1098, 580, 1270, 499, 961, 2935, 2951, 1399, 452, 1622, 172, 964, 1513, 1280, 1715, 1167, 93, 470, 1045, 1531, 2133, 2874, 500, 892, 110, 337, 1581, 919, 314, 298, 2353, 1260, 2108, 1655, 1433, 1132, 1909, 1094, 1361, 1492, 1815, 2047, 837, 922, 1681, 2282, 1333, 229, 1504, 328, 781, 774, 962, 1902, 2249, 1708, 674, 1495, 2287, 140, 2891, 1363, 482, 2438, 2466, 2517, 1696, 1448, 678, 546, 806, 1289, 2764, 454, 2294, 1046, 1973, 2637, 994, 1284, 1144, 1145, 223, 1081, 1966, 2037, 2630, 1436, 780, 2502, 632, 863, 2297, 726, 1700, 2880, 1853, 2089, 2045, 2575, 246, 1171, 1341, 2098, 1292, 2476, 2666, 648, 545, 526, 1391, 1972, 271, 629, 125, 2380, 432, 966, 1640, 2568, 1921, 1579, 1248, 1623, 2838, 1290, 1702, 916, 2316, 2887, 2444, 1637, 34, 1082, 762, 2112, 510, 1576, 2123, 769, 119, 2567, 2118, 2919, 2030, 98, 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219, 1825, 1839, 2384, 652, 2364, 1556, 2638, 1008, 2782, 2766, 2299, 2776, 2102, 1435, 2127, 1834, 2372, 2373, 1875, 2659, 829, 1434, 2488, 2826, 755, 2493, 2494, 665, 742, 2376, 1127, 1360, 1349, 391, 2507, 730, 1967, 1996, 2587, 2738, 332, 2180, 867, 2526, 2139, 902, 917, 1366, 2363, 2851, 2777, 2096, 2739, 2594, 2340, 1201, 2556, 587, 2847, 1061, 2072, 1691, 2433, 1861, 1653, 407, 1741, 833, 2725, 2326, 554, 2549, 2429, 214, 779, 2650, 2813, 799, 2101, 2071, 2076, 534, 2617, 1348, 1740, 2471, 813, 1530, 998, 2744, 1266, 2539, 2451, 2530, 2378, 2797, 987, 2228, 2229, 2781, 441, 2442, 60, 2853, 2716, 2546, 2252, 2195, 2808, 895, 509, 1381, 2837, 2593, 112, 2124, 478, 2558, 785, 291, 2387, 2768, 185, 2342, 2673, 1450, 1976, 2016, 1591, 443, 2674, 106, 127, 2461, 382, 661, 1157, 727, 2541, 2803, 1137, 2685, 2732, 2615, 1795, 2689, 59, 1128, 1377, 392, 1134, 2552, 2622, 2798, 1130, 2441, 2786, 296, 2578, 2631, 2778, 1074, 376, 2067, 1978, 1263, 2424, 663, 2459, 215, 871, 1678, 1196, 2330, 2492, 2482, 569, 1481, 2365, 2349, 2396, 2351, 2386, 436, 2462, 2608, 1654, 2160, 2301, 2559, 287, 944, 2399, 2683, 2176, 2412, 2746, 2770, 188, 2140, 2576, 2691, 1998, 635, 2762, 2619, 1089, 2421, 1256, 660, 1671, 743, 2729, 2524, 2750, 2804, 1287, 2751, 1079, 61, 2640, 2481, 2173, 2174, 2379, 2730, 693, 2398, 2562, 1388, 2440, 2532, 2795, 184, 2205, 2718, 1479, 1801, 2074, 1342, 2540, 405, 2585, 2577, 1535, 2393, 2682, 2385, 1882, 1860, 2574, 2058, 980, 2662, 1705, 260, 2389, 539, 2278, 748, 528, 2643, 2612, 1885, 1926, 2073, 2634, 2779, 2651, 572, 903, 2531, 2584, 410, 901, 728, 91, 218, 2375, 419, 2711, 2758, 2405, 2836, 2479, 2733, 275, 830, 540, 2475, 2094, 1411, 2824, 2715, 2704, 1222, 2728, 1244, 1397, 272, 2734, 2153, 1711, 1965, 1480, 2434, 1937, 2793, 1298, 2473, 2336, 2792, 338, 1237, 2566, 1151, 1152, 1347, 1977, 1836, 2422, 1131, 166, 746, 2590, 2757, 1739, 2765, 2348, 1484, 2884, 2325, 117, 2082, 1695, 2668, 817, 2632, 1536, 630, 2026, 1698, 593, 773, 2785, 2537, 2633, 2343, 2767, 936, 1830, 679, 1816, 1968, 2401, 544, 2519, 210, 1959, 777, 241, 242, 672, 2794, 2602, 403, 2168, 1168, 1562, 967, 1837, 118, 2010, 163, 2256, 1987, 2303, 2114, 1666, 2639, 1974, 2350, 240, 428, 1332, 1991, 2611, 2033, 2719, 1296, 2543, 26, 497, 1286, 838, 1291, 2244, 602, 523, 1051, 1951, 2366, 2017, 623, 1971, 664, 2144, 1320, 1855, 2708, 2944, 1238, 180, 2107, 2882, 139, 583, 350, 628, 1865, 1240, 550, 2169, 2406, 1464, 1494, 491, 167, 2921, 385, 2646, 2220, 1930, 2477, 1551, 1794, 2091, 1233, 2554, 1463, 2854, 514, 294, 921, 2665, 1227, 955, 2832, 2122, 2007, 1706, 609, 2087, 2298, 2802, 1064, 2128, 1958, 1068, 1703, 2761, 2347, 1907, 2544, 1737, 1135, 2053, 2870, 621, 266, 2799, 1748, 1490, 1870, 658, 604, 1828, 1574, 603, 910, 1425, 1988, 557, 138, 1452, 262, 2627, 1620, 2754, 2652, 1180, 354, 1813, 2918, 2011, 373, 1121, 421, 1844, 1385, 834, 2000, 2388, 2591, 1364, 2743, 2790, 148, 890, 236, 870, 1835, 2391, 2748, 2356, 2344, 2182, 1223, 2911, 1288, 2121, 2008, 2714, 850, 965, 2688, 2604, 662, 868, 2501, 1483, 1489, 2780, 2439, 1528, 647, 1820, 2618, 1232, 2675, 426, 2583, 2175, 2491, 1984, 2695, 2791, 393, 592, 1371, 1125, 1031, 1085, 1864, 645, 1565, 179, 1372, 945, 1449, 1186, 2078, 1557, 1318, 1264, 1351, 1821, 2077, 1867, 1198, 1812, 2066, 212, 933, 1676, 1634, 536, 1541, 1338, 1520, 1955, 178, 249, 2497, 1418, 1251, 1176, 1417, 2625, 1899, 1454, 1055, 1962, 1015, 1124, 1547, 2663, 2266, 1230, 2772, 1543, 956, 1744, 2110, 1553, 2498, 2505, 2922, 2090, 982, 1639, 657, 2499, 2141, 1619, 143, 1368, 1149, 292, 113, 2458, 105, 1742, 1949, 1850, 1901, 845, 2100, 273; (3) System Code: 722028; UDI: 00884838054202; System Serial Number: 1756, 1569, 1956, 129, 1233, 2206, 1690, 928, 1774, 2502, 317, 869, 668, 1017, 406, 540, 548, 590, 596, 1957, 110, 2261, 173, 1310, 866, 1043, 466, 1077, 877, 896, 987, 995, 1343, 1439, 895, 265, 305, 1154, 1000, 1909, 121, 1716, 1983, 2061, 784, 729, 1393, 1948, 525, 1656, 1461, 209, 825, 408, 570, 218, 734, 1050, 1751, 454, 1428, 666, 1094, 169, 2173, 1214, 52, 66, 493, 994, 373, 1213, 339, 234, 1836, 364, 982, 190, 1394, 1396, 1646, 818, 1650, 2275, 1058, 1353, 1466, 71, 910, 751, 1340, 1978, 254, 326, 166, 431, 1211, 318, 11, 543, 1651, 131, 133, 138, 547, 550, 2710, 1326, 267, 759, 821, 1232, 925, 127, 132, 141, 145, 180, 160, 468, 961, 1736, 1619, 2933, 1567, 282, 1130, 1100, 1570, 529, 1385, 1267, 2103, 464, 1395, 526, 1408, 280, 741, 211, 261, 1269, 1837, 601, 1051, 1988, 854, 744, 956, 2020, 2601, 1261, 1835, 559, 967, 1483, 2846, 2745, 2249, 1103, 1311, 880, 946, 949, 518, 519, 2645, 731, 678, 1116, 1880, 911, 118, 2192, 142, 376, 67, 1171, 273, 1498, 1156, 1279, 522, 564, 158, 1708, 1710, 558, 521, 906, 1155, 1085, 811, 462, 677, 1946, 316, 184, 185, 1834, 675, 1652, 1011, 203, 204, 1508, 2615, 346, 1890, 2293, 618, 262, 580, 654, 1149, 1484, 1995, 1397, 1456, 274, 1288, 402, 1556, 1201, 1129, 976, 2348, 2641, 479, 447, 805, 922, 1068, 1069, 973, 371, 23040202, 167, 485, 1095, 1870, 2253, 892, 130, 2295, 2071, 1327, 1099, 903, 1407, 620, 176, 1920, 257, 205, 2707, 2709, 2174, 819, 151, 539, 1275, 656, 361, 1142, 721, 1111, 779, 463, 1122, 481, 806, 310, 491, 2151, 1352, 888, 697, 1755, 1855, 445, 80, 840, 842, 2310, 2506, 655, 379, 553, 377, 632, 638, 2007, 2008, 968, 781, 154, 774, 1850, 1522, 451, 140, 1413, 1448, 1538, 1930, 743, 340, 535, 938, 206, 31, 1081, 990, 808, 1633, 1634, 315, 1387, 1630, 143, 586, 989, 1824, 236, 237, 238, 356, 1481, 717, 887, 1202, 541, 565, 416, 336, 303, 476, 2407, 189, 2635, 1809, 538, 904, 785, 350, 473, 329, 549, 874, 1049, 669, 1333, 684, 582, 224, 1264, 281, 475, 981, 1447, 1188, 1189, 696, 966, 333, 1875, 128, 1405, 1482, 930, 932, 498, 1001, 1041, 647, 674, 864, 1054, 1032, 698, 2252, 260, 630, 275, 419, 1266, 1472, 917, 2070, 971, 1014, 1200, 1374, 1499, 1222, 426, 459, 1705, 592, 1514, 531, 456, 571, 2110, 891, 867, 625, 452, 453, 672, 136, 137, 530, 2200, 1783, 48, 1350, 1723, 1454, 2922, 324, 1098, 256, 983, 1856, 978, 1132, 1187, 363, 1889, 1076, 952, 499, 1441, 210, 720, 556, 768, 2843, 560, 194, 195, 197, 227, 229, 627, 1457, 139, 552, 2284, 228, 122, 1424, 2647, 893, 879, 1854, 924, 934, 313, 1004, 528, 1373, 159, 1846, 962, 1984, 2422, 494, 1949, 918, 998, 1463, 1191, 1212, 1370, 1002, 2834, 490, 382, 2760, 1600, 1244, 1030, 207, 208, 1869, 2196, 1446, 1828, 636, 901, 1349, 1351, 561, 1074, 680, 1677, 908, 1629, 1, 272, 449, 516, 533, 991, 422, 1034, 889, 1822, 306, 900, 914, 671, 882, 372, 695, 945, 125, 368, 1639, 1136, 215, 279, 631, 637, 2083, 161, 534, 242, 284, 375, 365, 579, 1820, 1331, 809, 1566, 1598, 407, 1826, 489, 1368, 155, 1649, 1549, 496, 1568, 1845, 1980, 710, 793, 213, 692, 929, 861, 1035, 1024, 1256, 222, 394, 428, 1022, 343, 424, 435, 437, 1811, 251, 1168, 1657, 940, 878, 1572, 663, 231, 742, 905, 758, 1039, 942, 763, 1056, 2347, 1271, 1363, 2317, 760, 2322, 2589, 1193, 1873, 1915, 1280, 1255, 1814, 1830, 546, 36, 575, 816, 149, 2818, 713, 1583, 659, 660, 183, 1709, 1718, 1928, 2194, 2273, 1914, 770, 1687, 935, 49, 2545, 2958, 801, 2048, 856, 335, 2418, 824, 277, 1362, 883, 884, 1400, 1021, 1235, 1329, 1462, 2314, 767, 800, 826, 1416, 588, 2475, 1295, 2021, 1844, 2155, 2708, 1810, 1635, 1636, 10, 2178, 2002, 2758, 1726, 2421, 616, 748, 658, 505, 524, 232, 777, 1332, 2233, 443, 972, 370, 1911, 413, 2659, 2172, 2663, 2093, 2608, 480, 2350, 788, 870, 235, 2778, 2352, 2927, 2701, 381, 2098, 433, 1786, 2568, 2924, 1165, 1785, 244, 2482, 438, 2797, 1321, 1877, 792, 32, 1559, 1601, 2671, 2897, 460, 1571, 1551, 168, 178, 1604, 812, 1287, 1979, 35, 1247, 1857, 730, 2489, 511, 1061, 964, 187, 302, 2578, 862, 287, 1006, 2572, 545, 997, 1242, 830, 1682, 780, 1060, 1059, 2427, 91, 1325, 360, 1173, 330, 247, 182, 2839, 188, 1314, 504, 2915, 1157, 2538, 2090, 193, 1831, 852, 611, 2547, 79, 2887, 2594, 1924, 753, 1603, 2850, 1821, 2230, 2232, 412, 551, 665, 2025, 266, 2107, 170, 171, 790, 1558, 1621, 1540, 835, 1120, 1679, 2212, 2532, 2086, 2587, 2877, 2814, 1789, 2364, 1688, 963, 157, 1878, 1866, 322, 1562, 527, 937, 1613, 1421, 1713, 1389, 2099, 980, 1669, 765, 986, 754, 1893, 2217, 881, 1378, 2372, 2373, 1112, 523, 2751, 2351, 2481, 2483, 1328, 278, 2095, 689, 135, 434, 766, 1695, 1694, 64, 1007, 1704, 432, 635, 501, 794, 200, 405, 423, 1148, 1675, 1293, 965, 2334, 1460, 1775, 348, 153, 1819, 1865, 396, 984, 1952, 1815, 642, 912, 738, 993, 1386, 1259, 1925, 436, 827, 1186, 1730, 894, 506, 2066, 2676, 2953, 685, 1895, 2612, 617, 1458, 2079, 510, 1493, 1382, 233, 514, 813, 621, 1529, 2918, 2901, 670, 2028, 2755, 687, 2041, 1218, 38, 1700, 1067, 1313, 1254, 536, 1205, 441, 2408, 1517, 2833, 1419, 2024, 201, 555, 853, 439, 1178, 612, 323, 248, 1151, 1152, 319, 309, 362, 2168, 578, 2143, 1079, 126, 1082, 694, 1172, 2451, 1527, 2668, 2921, 264, 77, 2759, 2821, 2874, 2810, 2187, 2379, 2152, 2911, 2912, 1347, 589, 718, 1046, 430, 388, 2609, 2463, 725, 2478, 2570, 2618, 2621, 327, 2255, 1719, 2658, 803, 2374, 2820, 2555, 1437, 2362, 338, 773, 2605, 2700, 2258, 1008, 1843, 728, 469, 775, 1578, 1579, 1947, 2400, 1702, 367, 2713, 1881, 2455, 2320, 2690, 2527, 1812, 2222, 2873, 2336, 2019, 1686, 1632, 2513, 2424, 2425, 2889, 2673, 2732, 181, 221, 374, 164, 112, 2929, 782, 939, 2328, 2824, 1391, 442, 2126, 562, 1953, 2764, 1070, 1781, 2867, 1089, 2383, 119, 2000, 492, 411, 1693, 899, 1797, 2765, 198, 640, 863, 1863, 2939, 2500, 1066, 2302, 23, 1587, 1128, 2132, 2112, 783, 1018, 2490, 1113, 1734, 1994, 1769, 1813, 341, 290, 2259, 810, 1418, 795, 1545, 2344, 328, 2262, 933, 465, 955, 1940, 2838, 1506, 2702, 214, 99, 1364, 1219, 1285, 776, 2559, 1766, 1354, 1699, 2304, 2305, 2306, 2461, 1586, 2417, 2245, 607, 1959, 2954, 2625, 2774, 2115, 2140, 2298, 1449, 2569, 711, 2089, 2827, 192, 1776, 1932, 2085, 602, 472, 954, 1125, 115, 600, 1317, 2798, 2237, 1459, 2195, 1894, 2456, 414, 1337, 1433, 1515, 2292, 1612, 2058, 2614, 249, 2038, 1597, 1246, 2391, 2311, 2087, 2001, 2706, 1294, 2045, 2501, 1848, 2553, 1477, 2721, 2511, 2720, 2697, 2698, 37, 2177, 2837, 270, 1605, 1616, 1141, 1231, 609, 1610, 1618, 1417, 1479, 1626, 544, 970, 1582, 1092, 1617, 921, 1404, 2426, 1525, 1399, 1608, 81, 2059, 2603, 297, 944, 1743, 212, 855, 628, 2790, 701, 2825, 114, 165, 2623, 574, 295, 745, 985, 1210, 199, 2153, 1487, 1488, 13, 219, 676, 1584, 1071, 1075, 1063, 1040, 444, 2105, 230, 1907, 2617, 2430, 2675, 123, 1207, 1307, 1308, 87, 2145, 724, 1735, 2246, 502, 1038, 1228, 2250, 389, 799, 585, 651, 2934, 2952, 2666, 2639, 733, 1180, 1369, 1383, 661, 2133, 2135, 54, 857, 2951, 1411, 1717, 2677, 2714, 2444, 1181, 1029, 2248, 1384, 29, 2324, 1042, 1898, 2355, 1388, 875, 714, 2534, 2460, 1027, 1622, 2945, 2121, 2416, 1576, 2433, 1580, 2826, 1047, 1902, 1577, 2215, 1301, 843, 712, 2491, 286, 820, 2575, 1065, 1623, 1624, 1425, 2084, 2218, 1772, 2043, 931, 2602, 2522, 2576, 1117, 1724, 1534, 2388, 2484, 2438, 2033, 1768, 2157, 1300, 2197, 2319, 2097, 2139, 2012, 2731, 2851, 838, 1511, 2630, 2291, 1969, 2312, 2747, 2788, 837, 1251, 2525, 708, 603, 604, 2081, 2646, 2111, 1341, 2016, 2034, 2186, 1357, 1520, 2746, 2415, 1422, 2361, 2470, 2828, 1887, 2908, 2243, 2069, 2204, 2205, 2479, 1489, 2080, 1166, 2734, 1127, 2345, 2849, 2743, 2803, 1832, 2368, 2733, 507, 508, 2403, 2404, 2779, 1324, 1728, 1490, 2113, 2655, 1163, 2473, 2349, 2528, 1588, 2209, 2723, 2318, 1107, 2091, 2327, 2332, 1516, 988, 1316, 2221, 1732, 2719, 2669, 2891, 1662, 915, 2792, 2763, 948, 2940, 2858, 2606, 186, 1970, 1496, 1026, 1973, 2487, 2229, 1252, 2515, 2063, 2741, 2624, 487, 2480, 2591, 2213, 1900, 1753, 2296, 2910, 1376, 2051, 2736, 1805, 2619, 2616, 2120, 1939, 1891, 1745, 2183, 2560, 1478, 2518, 1543, 2129, 2216, 2767, 1410, 876, 2535, 2626, 2914, 1747, 2339, 2036, 2100, 1431, 2771, 2044, 2405, 1185, 1647, 735, 736, 737, 2631, 2680, 2643, 1470, 2804, 2271, 2381, 1537, 2459, 2784, 2832, 2892, 2193, 1839, 1497, 2227, 1208, 2130, 2750, 2712, 2777, 2476, 2477, 2661, 1987, 1892, 2860, 2018, 2127, 2223, 1194, 2529, 2656, 2064, 1760, 2894, 2780, 1298, 1564, 1589, 1471, 2279, 2822, 2188, 2881, 2042, 2556, 2466, 1806, 1055, 2366, 2367, 2627, 2696, 1474, 2220, 1096, 1581, 2387, 2536, 1336, 2896, 2340, 2685, 2359, 2363, 2565, 1561, 2516, 2717, 2032, 1057, 2125, 2863, 2464, 2931, 1770, 1048, 2321, 1315, 848, 2072, 2845, 1885, 2201, 2744, 1933, 1167, 2521, 1512, 1777, 2137, 2644, 2369, 2432, 2358, 2693, 2542, 2147, 2031, 1531, 2816, 2210, 2566, 2649, 2396, 1106, 1767, 1121, 1941, 2159, 2287, 2323, 2756, 1790, 2162, 2783, 1377, 1681, 1780, 2812, 1289, 1906, 2705, 2517, 2504, 2660, 2592, 2505, 2166, 2441, 1131, 2942, 2428, 2040, 2600, 2094, 2571, 1974, 2389, 2552, 2300, 2540, 2131, 2411, 2882, 1804, 1674, 1245, 2950, 2886, 1867, 2684, 1711, 2439, 2254, 1696, 2947, 2795, 2557, 2730, 2512, 2138, 2393, 1536, 2257, 1541, 1240, 1402, 815, 1990, 2757, 1138, 2793, 1801, 2167, 1229, 2392, 2728, 1903, 2265, 2836, 2234, 1882, 2285, 2880, 1803, 2796, 2397, 2114, 2297, 2856, 1916, 2068, 2588, 2737, 2738, 1998, 1764, 831, 1217, 2436, 936, 2613, 2458, 2346, 2409, 1778, 2802, 2904, 2567, 2465, 2859, 2775, 2670, 1455, 1921, 2488, 1468, 1871, 1091, 2161, 2468, 2075, 2182, 2715, 2165, 2333, 2735, 2023, 1360, 2228, 1908, 1196, 1752, 2509, 2370, 1427, 2214, 2303, 1962, 2523, 2184, 2628, 2027, 2175, 2956, 2749, 1250, 1942, 2868, 2941, 2888, 1899, 2648, 2762, 2794, 2633, 2283, 2454, 1862, 1574, 2301, 2857, 2146, 2117, 1929, 2092, 2208, 1876, 2679, 2634, 907, 1664, 2691, 2704, 2378, 1599, 2148, 2930, 2854, 2492, 1765, 1739, 2742, 2651, 1725, 2607, 2022, 2203, 1290, 2586, 2776, 2899, 2142, 2549, 2913, 503, 162, 2457, 2202, 2440, 2574, 2748, 1935, 2185, 1415, 1912, 2687, 2688, 2872, 2288, 2141, 2640, 1542, 2593, 2486, 1991, 2264, 1528, 1744, 2164, 2326, 2844, 2835, 2325, 1594, 2469, 2419, 2420, 1888, 2453, 2309, 1976, 2497, 1192, 2564, 2548, 2584, 1905, 2870, 2650, 2282, 2841, 2154, 1742, 2251, 2672, 2329, 2629, 1796, 2394, 943, 1793, 2902, 2903, 2014, 2343, 2013, 2498, 1678, 796, 1161, 2909, 2773, 1504, 2109, 2128, 2307, 2499, 2526, 2096, 1910, 2923, 2769, 2242, 2878, 1841, 1643, 2052, 1944, 2937, 2406, 1727, 2337, 1465, 2382, 2313, 2768, 2754, 1923, 2766, 1216, 2596, 1642, 1573, 2462, 1575, 2160, 1761, 1680, 1665, 755, 715, 2448, 1530, 2530, 1965, 2554, 2597, 1904, 2599, 2781, 2782, 2116, 1552, 1469, 1683, 2524, 1019, 2611, 2118, 2365, 1473, 1544, 1253, 1808, 1963, 2360, 2943, 1153, 2864, 1795, 2925, 2852, 2412, 2067, 1762, 1738, 2561, 1958, 1355, 1593, 2341, 1223, 2260, 1158, 2722, 1661, 1849, 2119, 1663, 1521, 2562, 2800, 1847, 2449, 2829, 2395, 2595, 1464, 2270, 1992, 2219, 2580, 999, 1518, 2740, 1997, 2225, 2683, 2136, 2871, 2399, 1981, 2919, 1773, 1659, 1401, 2884, 1409, 2801, 2866, 1276, 2890, 2686, 2272, 2437, 2739, 2474, 2278, 2062, 2808, 2268, 1510, 2156, 2817, 2263, 2543, 2948, 2865, 2653, 2875, 1961, 2520, 2003, 1943, 2452, 2401, 2932, 2787, 1502, 2144, 2848, 2331, 2078, 2380, 2011, 1653, 2689, 1954, 1763, 1697, 1162, 1398, 2582, 1746, 2289, 2508, 2442, 2269, 2861, 1670, 1671, 2226, 2308, 1227, 2431, 2678, 2544, 2299, 624, 2716, 2944, 2563, 1668, 2807, 337, 2869, 1443, 2471, 690, 1097, 797, 747, 1720, 573, 844, 845, 846, 1258, 802, 104, 1555, 1292, 817, 778, 764, 369, 2667, 1302, 150, 941, 380, 2830, 1044, 1451, 2102, 320, 353, 1159, 1025, 762, 1638, 839, 1645, 814, 1088, 63, 116, 1312, 2207, 1403, 484, 2632, 1134, 1135, 850, 1359, 1802, 2485, 1342, 2938, 1535, 2900, 1146, 639, 2847, 1703, 179, 2077, 398, 2495, 1539, 2390, 1206, 1986, 1438, 1086, 1087, 851, 2770, 1937, 9, 2831, 105, 111, 2076, 951, 2035, 2256, 2519, 1816, 1817, 652, 467, 2169, 1945, 1818, 2104, 709, 926, 440, 2398, 823, 1532, 822, 2445, 2163, 1184, 2726, 392, 2037, 1442, 1596, 568, 1972, 2410, 2772, 2450, 1123, 1124, 2809, 101, 2353, 1879, 1977, 2692, 107, 124, 225, 1660, 1968, 1654, 113, 832, 415, 727, 387, 2108, 1851, 608, 1554, 576, 577, 30, 1105, 1346, 1309, 716, 14, 726, 723, 722, 2585, 1361, 613, 1689, 1792, 191, 1209, 1500, 298, 299, 300, 1221, 614, 1884, 1825, 2503, 2546, 2681, 2853, 1913, 2236, 2238, 1064, 1320, 2895, 2531, 2840, 2928, 1960, 2472, 2879, 2015, 1595, 1901, 1692, 650, 662, 175, 2356, 2357, 1073, 2274, 1602, 1390, 1372, 702, 834, 606, 1045, 2101, 1037, 557, 593, 594, 301, 732, 98, 156, 1548, 2598, 1426, 919, 2467, 2620, 1265, 1268, 2622, 43, 2496, 2082, 1546, 1547, 395, 1432, 2294, 679, 1858, 483, 1304, 1429, 1101, 2898, 1553, 1971, 1926, 641, 1145, 2957, 2694, 2695, 2823, 1791, 975, 2006, 2558, 41, 1757, 40, 163, 1367, 27, 2907, 1356, 1358, 2514, 615, 2049, 2198, 2682, 2004, 2936, 2267, 1886, 2386, 2799, 1627, 2413, 2122, 1164, 2423, 1503, 2338, 2158, 2657, 1838, 2354, 2429, 2811, 791, 969, 1784, 1874, 2149, 1585, 2946, 1615, 2935, 1934, 2046, 2718, 2577, 1868, 2893, 1896, 2434, 2330, 1104, 868, 455, 1712, 259, 1982, 314, 355, 847, 269, 643, 705, 34, 860, 1118, 1183, 756, 2189, 1918, 1625, 623, 1715, 2150, 2029, 703, 1684, 2074, 296, 226, 1788, 2073, 704, 429, 707, 1685, 1731, 1799, 458, 311, 2170, 291, 1102, 1557, 974, 2171, 1170, 2026, 1740, 597, 1241, 2190, 1297, 103, 120, 512, 482, 693, 599, 947, 1996, 673, 2065, 74, 2949, 633, 648, 657, 2199, 1550, 1453, 276, 403, 517, 1975, 1714, 245, 1090, 2785, 2786, 649, 334, 898, 285, 605, 427, 752, 622, 1257, 354, 653, 366;
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Kilt
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8K303; UDI-DI (Product Code): 00840331297638 (FKILTC18-C8K303-2XM, FKILTC8-C8K303-LF, FKILTC8-C8K303-LM, FKILTC8-C8K303-MF, FKILTC8-C8K303-MM, FKILTC8-C8K303-PLUS, FKILTC8-C8K303-SF, FKILTC8-C8K303-SM, FKILTC8-C8K303-XLF, FKILTC8-C8K303-XLM, FKILTC8-C8K303-XSF, FKILTT18-C8K303-LM, FKILTT18-C8K303-MM, FKILTT18-C8K303-PLUS, FKILTT18-C8K303-SM, FKILTT18-C8K303-XLM, FKILTT18-C8K303-XSM, FKILTT28-C8K303-2XM, FKILTT28-C8K303-4XM, FKILTT28-C8K303-5XM). 2. Model Number: R8K303; UDI-DI (Product Code): 00197513003618 (FKILTC18-R8K303-2XF ), 00197513003618 (FKILTC18-R8K303-3XF ), 00197513002932 (FKILTC8-R8K303-LF ), 00197513002925 (FKILTC8-R8K303-LM ), 00197513002918 (FKILTC8-R8K303-MF ), 00197513002901 (FKILTC8-R8K303-MM ), 00197513002888 (FKILTC8-R8K303-SF ), 00197513002871 (FKILTC8-R8K303-SM ), 00197513002864 (FKILTC8-R8K303-XLF ), 00197513000068 (FKILTT18-R8K303-LF ), 00197513000198 (FKILTT18-R8K303-LM ), 00197513000068 (FKILTT18-R8K303-MF ), 00197513000198 (FKILTT18-R8K303-MM ), 00197513000068 (FKILTT18-R8K303-PLUS ), 00197513000068 (FKILTT18-R8K303-SF ), 00197513000198 (FKILTT18-R8K303-SM ), 00197513000068 (FKILTT18-R8K303-XLF ), 00197513000198 (FKILTT18-R8K303-XLM ), 00197513000198 (FKILTT18-R8K303-XSM ), 00197513000068 (FKILTT28-R8K303-2XF ), 00197513000068 (FKILTT28-R8K303-3XF ), 00197513000198 (FKILTT28-R8K303-3XM ), 00197513000068 (FKILTT28-R8K303-4XF ), 00197513000068 (FKILTT38-R8K303-6XF ). 3. Model Number: R8KILT; UDI-DI (Product Code): None (IKILTC8-R8KILT-LMR ), None (IKILTC8-R8KILT-SMR ), 00840331259681 (KILTC18-R8KILT-2XF ), 00840331259698 (KILTC18-R8KILT-2XM ), 00840331259704 (KILTC18-R8KILT-3XF ), 00840331259711 (KILTC18-R8KILT-3XM ), 00840331259728 (KILTC8-R8KILT-LF ), 00840331259735 (KILTC8-R8KILT-LM ), 00840331259735 (KILTC8-R8KILT-MF ), 00840331259759 (KILTC8-R8KILT-MM ), 00840331259766 (KILTC8-R8KILT-PLUS ), 00840331259773 (KILTC8-R8KILT-SF ), 00840331259780 (KILTC8-R8KILT-SM ), 00840331259797 (KILTC8-R8KILT-XLF ), 00840331259803 (KILTC8-R8KILT-XLM ), 00840331259810 (KILTC8-R8KILT-XSF ), 00840331259827 (KILTC8-R8KILT-XSM ), 00840331259728 (KILTS8-R8KILT-LF ), 00840331259735 (KILTS8-R8KILT-LM ), 00840331259742 (KILTS8-R8KILT-MF ), 00840331259759 (KILTS8-R8KILT-MM ), 00840331259766 (KILTS8-R8KILT-PLUS ), 00840331259773 (KILTS8-R8KILT-SF ), 00840331259780 (KILTS8-R8KILT-SM ), 00840331259797 (KILTS8-R8KILT-XLF ), 00840331259803 (KILTS8-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-LF ), 00840331269932 (KILTT18-R8KILT-LM ), 00840331269925 (KILTT18-R8KILT-MF ), 00840331269932 (KILTT18-R8KILT-MM ), 00840331269925 (KILTT18-R8KILT-PLUS ), 00840331269925 (KILTT18-R8KILT-SF ), 00840331269932 (KILTT18-R8KILT-SM ), 00840331269925 (KILTT18-R8KILT-XLF ), 00840331269932 (KILTT18-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-XSF ), 00840331269932 (KILTT18-R8KILT-XSM ), 00840331269925 (KILTT28-R8KILT-2XF ), 00840331269932 (KILTT28-R8KILT-2XM ), 00840331269925 (KILTT28-R8KILT-3XF ), 00840331269932 (KILTT28-R8KILT-3XM ), 00840331269925 (KILTT28-R8KILT-4XF ), 00840331269932 (KILTT28-R8KILT-4XM ), 00840331269925 (KILTT28-R8KILT-5XF ), 00840331269932 (KILTT28-R8KILT-5XM ), 00840331269925 (KILTT38-R8KILT-6XF ), 00840331269932 (KILTT38-R8KILT-6XM ), 00840331269925 (KILTT38-R8KILT-7XF ), 00840331269932 (KILTT38-R8KILT-7XM ), 00840331269925 (KILTT38-R8KILT-8XF ), 00840331269932 (KILTT38-R8KILT-8XM ), None (IKILTC8-R8KILT-LFL ), None (IKILTC8-R8KILT-LFR ), None (IKILTC8-R8KILT-MFL ), None (IKILTC8-R8KILT-MFR ), None (IKILTC8-R8KILT-MFXL ), None (IKILTC8-R8KILT-MML ), None (IKILTC8-R8KILT-MMR ), None (IKILTC8-R8KILT-SFL ), None (IKILTC8-R8KILT-SML ), None (IKILTC8-R8KILT-XSFR ), None (IKILTC8-R8KILT-2XFL ), None (IKILTC8-R8KILT-2XFR ), None (IKILTC8-R8KILT-3XFR ), None (IKILTC8-R8KILT-LFS ), None (IKILTC8-R8KILT-LML ), None (IKILTC8-R8KILT-LMXL ), None (IKILTC8-R8KILT-MFS ), None (IKILTC8-R8KILT-SFS ), None (IKILTC8-R8KILT-XLMR ), None (IKILTC8-R8KILT-2XMXL ), None (IKILTC8-R8KILT-PLUSL ), None (IKILTC8-R8KILT-SFR ), None (IKILTC8-R8KILT-XLML ), None (IKILTC8-R8KILT-XSFS ), None (IKILTC8-R8KILT-MMXL ), None (IKILTC8-R8KILT-XLMXL ), None (IKILTC8-R8KILT-2XMR ), None (IKILTC8-R8KILT-XSML ), None (IKILTC8-R8KILT-XSMR ), None (IKILTC8-R8KILT-XSMXL ), None (IFKILTC8-R8K303-LFR), None (IFKILTC8-R8K303-MMR). 4. Model Number: R8S302; UDI-DI (Product Code): 00197513004950 (SKIRTWBC8-R8S302-LF ), 00197513004943 (SKIRTWBC8-R8S302-LM ), 00197513004936 (SKIRTWBC8-R8S302-MF ), 00197513004929 (SKIRTWBC8-R8S302-MM ), 00197513004912 (SKIRTWBC8-R8S302-PLUS ), 00197513004905 (SKIRTWBC8-R8S302-SF ), 00197513004899 (SKIRTWBC8-R8S302-SM ), 00197513004875 (SKIRTWBC8-R8S302-XLM ), 00197513000327 (SKIRTWBT18-R8S302-LF ), 00197513000457 (SKIRTWBT18-R8S302-LM ), 00197513000327 (SKIRTWBT18-R8S302-MF ), 00197513000457 (SKIRTWBT18-R8S302-MM ), 00197513000327 (SKIRTWBT18-R8S302-PLUS ), 00197513000457 (SKIRTWBT18-R8S302-SM ), 00197513000327 (SKIRTWBT18-R8S302-XLF ), 00197513000457 (SKIRTWBT18-R8S302-XLM ), 00197513000457 (SKIRTWBT28-R8S302-2XM ), 00197513000327 (SKIRTWBT28-R8S302-3XF ), 00197513000457 (SKIRTWBT28-R8S302-3XM ), 00197513000457 (SKIRTWBT28-R8S302-4XM ), 00197513000327 (SKIRTWBT28-R8S302-5XF ), 00197513000457 (SKIRTWBT28-R8S302-5XM ), 00197513000327 (SKIRTWBT38-R8S302-6XF ), 00197513000457 (SKIRTWBT38-R8S302-6XM ), 00197513000327 (SKIRTWBT38-R8S302-8XF ), 00197513000457 (SKIRTWBT38-R8S302-8XM ), None (ISKIRTWBC8-R8S302-MFL ), None (ISKIRTWBC8-R8S302-MFR ), None (ISKIRTWBC8-R8S302-MML ), None (ISKIRTWBC8-R8S302-MMR ), None (ISKIRTWBC8-R8S302-MMXL ), None (ISKIRTWBC8-R8S302-PLUSL ), None (ISKIRTWBC8-R8S302-SFL ), None (ISKIRTWBC8-R8S302-SML ). 5. Model Number: R8SKIRT; UDI-DI (Product Code): 00840331260182 (SKIRTC8-R8SKIRT-LM ), 00840331260205 (SKIRTC8-R8SKIRT-MM ), 00840331260250 (SKIRTC8-R8SKIRT-XLM ), 00840331269987 (SKIRTT18-R8SKIRT-LF ), 00840331269994 (SKIRTT18-R8SKIRT-LM ), 00840331269987 (SKIRTT18-R8SKIRT-MF ), 00840331269994 (SKIRTT18-R8SKIRT-MM ), 00840331269987 (SKIRTT18-R8SKIRT-PLUS ), 00840331269994 (SKIRTT18-R8SKIRT-SM ), 00840331269987 (SKIRTT18-R8SKIRT-XLF ), 00840331269994 (SKIRTT18-R8SKIRT-XLM ), 00840331269994 (SKIRTT18-R8SKIRT-XSM ), 00840331269987 (SKIRTT28-R8SKIRT-2XF ), 00840331269994 (SKIRTT28-R8SKIRT-2XM ), 00840331269994 (SKIRTT28-R8SKIRT-3XM ), 00840331269994 (SKIRTT28-R8SKIRT-4XM ), 00840331270013 (SKIRTT38-R8SKIRT-6XM ). 6. Model Number: S8K303; UDI-DI (Product Code): 00197513002802 (FKILTC8-S8K303-LM ), 00197513002796 (FKILTC8-S8K303-MF ), 00197513002789 (FKILTC8-S8K303-MM ), 00197513002734 (FKILTC8-S8K303-XLM ), 00197513002727 (FKILTC8-S8K303-XSF ), 00197513000051 (FKILTT18-S8K303-MF ), 00197513000181 (FKILTT18-S8K303-MM ), 00197513000051 (FKILTT18-S8K303-PLUS ), 00197513000181 (FKILTT18-S8K303-SM ), 00197513000181 (FKILTT18-S8K303-XSM ), 00197513000181 (FKILTT28-S8K303-2XM ), 00197513000051 (FKILTT28-S8K303-3XF ), 00197513000181 (FKILTT28-S8K303-3XM ), 00197513000181 (FKILTT28-S8K303-4XM ). 7. Model Number: S8KILT; UDI-DI (Product Code): 00840331263435 (KILTC18-S8KILT-2XF ), 00840331263442 (KILTC18-S8KILT-2XM ), 00840331263459 (KILTC18-S8KILT-3XF ), 00840331263466 (KILTC18-S8KILT-3XM ), 00840331263473 (KILTC8-S8KILT-LF ), 00840331263480 (KILTC8-S8KILT-LM ), 00840331263497 (KILTC8-S8KILT-MF ), 00840331263503 (KILTC8-S8KILT-MM ), 00840331263510 (KILTC8-S8KILT-PLUS ), 00840331263527 (KILTC8-S8KILT-SF ), 00840331263534 (KILTC8-S8KILT-SM ), 00840331263541 (KILTC8-S8KILT-XLF ), 00840331263558 (KILTC8-S8KILT-XLM ), 00840331263565 (KILTC8-S8KILT-XSF ), 00840331263565 (KILTC8-S8KILT-XSM ), 00840331263473 (KILTS8-S8KILT-LF ), 00840331263480 (KILTS8-S8KILT-LM ), 00840331263497 (KILTS8-S8KILT-MF ), 00840331263503 (KILTS8-S8KILT-MM ), 00840331263527 (KILTS8-S8KILT-SF ), 00840331263534 (KILTS8-S8KILT-SM ), 00840331263541 (KILTS8-S8KILT-XLF ), 00840331263558 (KILTS8-S8KILT-XLM ), 00840331269949 (KILTT18-S8KILT-LF ), 00840331269956 (KILTT18-S8KILT-LM ), 00840331269949 (KILTT18-S8KILT-MF ), 00840331269956 (KILTT18-S8KILT-MM ), 00840331269949 (KILTT18-S8KILT-PLUS ), 00840331269949 (KILTT18-S8KILT-SF ), 00840331269956 (KILTT18-S8KILT-SM ), 00840331269949 (KILTT18-S8KILT-XLF ), 00840331269956 (KILTT18-S8KILT-XLM ), 00840331269949 (KILTT18-S8KILT-XSF ), 00840331269956 (KILTT18-S8KILT-XSM ), 00840331269949 (KILTT28-S8KILT-2XF ), 00840331269956 (KILTT28-S8KILT-2XM ), 00840331269949 (KILTT28-S8KILT-3XF ), 00840331269956 (KILTT28-S8KILT-3XM ), 00840331269949 (KILTT28-S8KILT-4XF ), 00840331269956 (KILTT28-S8KILT-4XM ), 00840331269949 (KILTT28-S8KILT-5XF ), 00840331269956 (KILTT28-S8KILT-5XM ), 00840331269949 (KILTT38-S8KILT-6XF ), 00840331269956 (KILTT38-S8KILT-6XM ), 00840331269949 (KILTT38-S8KILT-7XF ), 00840331269956 (KILTT38-S8KILT-7XM ), 00840331269949 (KILTT38-S8KILT-8XF ), 00840331269956 (KILTT38-S8KILT-8XM ), None (IKILTC8-S8KILT-LMR ), None (IKILTC8-S8KILT-MMR ). 8. Model Number: S8S302; UDI-DI (Product Code): 00197513004837 (SKIRTWBC8-S8S302-LF ), 00197513004820 (SKIRTWBC8-S8S302-LM ), 00197513004813 (SKIRTWBC8-S8S302-MF), 00197513004806 (SKIRTWBC8-S8S302-MM ), 00197513004790 (SKIRTWBC8-S8S302-PLUS), 00197513000310 (SKIRTWBT18-S8S302-LF ), 00197513000440 (SKIRTWBT18-S8S302-LM), 00197513000310 (SKIRTWBT18-S8S302-MF ), 00197513000440 (SKIRTWBT18-S8S302-MM), 00197513000310 (SKIRTWBT18-S8S302-PLUS ), 00197513000440 (SKIRTWBT18-S8S302-SM ), 00197513000310 (SKIRTWBT18-S8S302-XLF ), 00197513000440 (SKIRTWBT18-S8S302-XLM ), 00197513000440 (SKIRTWBT18-S8S302-XSM ), 00197513000310 (SKIRTWBT28-S8S302-3XF ), 00197513000440 (SKIRTWBT28-S8S302-3XM), 00197513000440 (SKIRTWBT28-S8S302-4XM ), 00197513000440 (SKIRTWBT28-S8S302-5XM ). 9. Model Number: S8SKIRT; UDI-DI (Product Code): 00840331270006 (SKIRTT18-S8SKIRT-LF ), 00840331270013 (SKIRTT18-S8SKIRT-LM ), 00840331270006 (SKIRTT18-S8SKIRT-MF ), 00840331270006 (SKIRTT18-S8SKIRT-PLUS ), 00840331270013 (SKIRTT18-S8SKIRT-SM ), 00840331270006 (SKIRTT18-S8SKIRT-XLF ), 00840331270006 (SKIRTT28-S8SKIRT-3XF ), 00840331270013 (SKIRTT28-S8SKIRT-4XM ). 10. Model Number: U8K303; UDI-DI (Product Code): 00197513002680 (FKILTC8-U8K303-LM), 00197513002673 (FKILTC8-U8K303-MF ), 00197513002666 (FKILTC8-U8K303-MM ), 00197513002642 (FKILTC8-U8K303-SF ), 00197513002635 (FKILTC8-U8K303-SM ), 00197513000174 (FKILTT18-U8K303-LM ), 00197513000044 (FKILTT18-U8K303-MF ), 00197513000174 (FKILTT18-U8K303-MM ), 00197513000044 (FKILTT18-U8K303-PLUS ), 00197513000174 (FKILTT18-U8K303-SM ), 00197513000174 (FKILTT28-U8K303-2XM ), 00197513000044 (FKILTT28-U8K303-4XF ), 00197513000174 (FKILTT28-U8K303-4XM ), 00197513000044 (FKILTT28-U8K303-5XF ), 00197513000174 (FKILTT28-U8K303-5XM ), None (IFKILTC8-U8K303-2XMR ), None (IFKILTC8-U8K303-LMR ), None (IFKILTC8-U8K303-MMR ), None (IFKILTC8-U8K303-SFR ), None (IFKILTC8-U8K303-SMR ), None (IFKILTC8-U8K303-XLMR ). 11. Model Number: U8KILT; UDI-DI (Product Code): 00840331267167 (KILTC18-U8KILT-2XF ), 00840331267174 (KILTC18-U8KILT-2XM ), 00840331267181 (KILTC18-U8KILT-3XF ), 00840331267204 (KILTC8-U8KILT-LF ), 00840331267211 (KILTC8-U8KILT-LM ), 00840331267228 (KILTC8-U8KILT-MF ), 00840331267235 (KILTC8-U8KILT-MM ), 00840331267242 (KILTC8-U8KILT-PLUS ), 00840331267259 (KILTC8-U8KILT-SF ), 00840331267266 (KILTC8-U8KILT-SM ), 00840331267273 (KILTC8-U8KILT-XLF ), 00840331267280 (KILTC8-U8KILT-XLM ), 00840331267297 (KILTC8-U8KILT-XSF ), 00840331267303 (KILTC8-U8KILT-XSM ), 00840331267204 (KILTS8-U8KILT-LF ), 00840331267211 (KILTS8-U8KILT-LM ), 00840331267228 (KILTS8-U8KILT-MF ), 00840331269963 (KILTT18-U8KILT-LF ), 00840331269970 (KILTT18-U8KILT-LM ), 00840331269963 (KILTT18-U8KILT-MF ), 00840331269970 (KILTT18-U8KILT-MM ), 00840331269963 (KILTT18-U8KILT-PLUS ), 00840331269963 (KILTT18-U8KILT-SF ), 00840331269970 (KILTT18-U8KILT-SM ), 00840331269963 (KILTT18-U8KILT-XLF ), 00840331269970 (KILTT18-U8KILT-XLM ), 00840331269970 (KILTT18-U8KILT-XSM ), 00840331269963 (KILTT28-U8KILT-2XF ), 00840331269970 (KILTT28-U8KILT-2XM ), 00840331269963 (KILTT28-U8KILT-3XF ), 00840331269970 (KILTT28-U8KILT-3XM ), 00840331269963 (KILTT28-U8KILT-4XF ), 00840331269970 (KILTT28-U8KILT-4XM ), 00840331269963 (KILTT28-U8KILT-5XF ), 00840331269970 (KILTT28-U8KILT-5XM ), 00840331269963 (KILTT38-U8KILT-6XF ), 00840331269970 (KILTT38-U8KILT-6XM ), 00840331269963 (KILTT38-U8KILT-7XF ), 00840331269970 (KILTT38-U8KILT-7XM ), 00840331269963 (KILTT38-U8KILT-8XF ), 00840331269970 (KILTT38-U8KILT-8XM ), None (IKILTC8-U8KILT-2XMR ), None (IKILTC8-U8KILT-LFR ), None (IKILTC8-U8KILT-LMR ), None (IKILTC8-U8KILT-LMXL ), None (IKILTC8-U8KILT-MFR ), None (IKILTC8-U8KILT-MMR ), None (IKILTC8-U8KILT-SFR ), None (IKILTC8-U8KILT-SMR ), None (IKILTC8-U8KILT-XLMR ), None (IKILTC8-U8KILT-XLMXL ), None (IKILTC8-U8KILT-XSFR ). 12. Model Number: U8S302; UDI-DI (Product Code): 00197513004714 (SKIRTWBC8-U8S302-LF ), 00197513004691 (SKIRTWBC8-U8S302-MF ), 00197513004684 (SKIRTWBC8-U8S302-MM ), 00197513004677 (SKIRTWBC8-U8S302-PLUS ), 00197513004660 (SKIRTWBC8-U8S302-SF ), 00197513004622 (SKIRTWBC8-U8S302-XSF ), 00197513000303 (SKIRTWBT18-U8S302-PLUS ).
Apr 8, 2026
View details →Intuitive surgical, inc.
High PriorityActive
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Lot Code: 420207: Tenaculum Forceps Instrument GTIN: 00886874111659 FDA Medical Number: D088920 Material Number: 420207-06 da Vinci System Numbers: SH1378 SH0935 SH0935 SH0935 USG294 SH0761 SH0729 SH1182 SH1378 USG022 SH1378 SH1368 SH0059 SH1015 SH1182 SH0825 USG294 SH1390 USG022 SH0495 SH0495 SH1076 SH1390 SH1390 SH1390 SH1276 SH1385 USG022 SH0547 SH1385 SH1391 SH2144 SH0059 SH1279 SH0059 SH1390 SH1570 SH0059 SH1391 SG704 SH1570 SH0729 SH1385 SH1378 USG518 SH1385 SH1837 USG294 SH1368 SH1390 SH1385 SH1368 SG2026 SH1557 SH2144 SH1385 USG518 SH1279 USG294 SH1391 Material Number: 420207-07 da Vinci System Numbers: SH1391 SH1385 SH1385 SH1279 SH2125 SH0729 SH1368 USG721 SH1385 SH1997 SH2125 USG294 SH1378 SH1997 SH0035 SG704 SH1385 SH1279 SH1279 SH2125 SH1378 SH1378 SH0495 SH1390 SH1390 SH1385 SH2125 SH1378 SH1385 SH1279 USG721 SH1279 SH1837 USG518 SH1385 SH1378 USG022 SH1378 SH1570 SH1385 SH1385 SH0935 SH0935 SG704 SG704 SH1378 USG022 SH1385 SH1279 USG721 SH1279 USG518 SH1837 SH1279 USG022 SH1385 SH1385 SH1964 SH1385 SH1390 SH1279 SH1964 SH1385 SH1570 USG294 SH1182 SH1279 SH1279 USG022 SH1385 SH0825 USG294 SH0035 SH1276 SH2125 SH1279 RSH0152 USG518 SH1557 SH1837 SH1385 SH1390 SH1279 SH1390 SH1390 USG294 SH1385 SH1279 SH1385 SH1279 SH2125 USG721 SH1837 SH0035 SH1964 SH1837 SH1385 SH1385 SH1279 SH1279 RSH0152 SH1378 SH0495 Material Number: 420207-09 da Vinci System Numbers: RSH0152 SH1378 SH1385 SH1279 USG721 SH1279 SH1378 SH1385 USG721 SH1279 SH1182 SH1390 SH1076 USG721 SH1279 SH1182 SH1385 SH1837 SH1279 SH1837 SH1279 Material Number: 420207-10 da Vinci System Numbers: SH1279 SH1385 SH1390 SH1279 SH1385 SH1182 SH1368 SH1997 SH1279 USG721 SH1822 SH1557 SH1822 SH1964 SH1279 SH0495 SH1390 SH1279 SH1964 USG022 SH1822 SH1378 SH1182 SH1837 SH1279 SH1279 SH1279 SH1279 SH1997 SH1964 SH1964 SH1997 SH0761 SH1279 SH1837 SH1279 SH1279 SH1279 SH1390 SH1279 SH1997
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Allura Xper FD20/15; System Code: 722058;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
System Code: 722058; UDI: 00884838059115; System Serial Number: 100, 239, 305, 259, 203, 373, 111, 38, 23, 290, 124, 274, 340, 366, 162, 186, 4, 196, 156, 285, 277, 65, 168, 56, 178, 138, 212, 249, 257, 337, 265, 109, 134, 71, 238, 190, 219, 197, 325, 24, 123, 319, 378, 61, 205, 149, 264, 167, 365, 199, 278, 215, 288, 254, 94, 304, 279, 171, 82, 85, 202, 99, 182, 22, 200, 129, 59, 172, 110, 399, 72, 332, 92, 142, 67, 106, 335, 415, 11, 114, 151, 93, 232, 395, 292, 380, 183, 349, 261, 15, 375, 161, 78, 368, 9, 372, 252, 320, 213, 293, 389, 169, 97, 336, 25, 143, 133, 192, 49, 412, 201, 101, 89, 66, 163, 170, 77, 273, 35, 222, 229, 248, 334, 384, 40, 268, 240, 258, 289, 269, 226, 244, 141, 391, 241, 164, 381, 281, 154, 246, 127, 315, 256, 233, 348, 204, 396, 7, 185, 95, 131, 377, 60, 68, 206, 150, 333, 84, 398, 313, 3, 39, 344, 376, 382, 408, 360, 370, 400, 387, 356, 419, 394, 407, 413, 392, 411, 358, 409, 385, 416, 367, 331, 379, 418, 421, 369, 420, 397, 357, 393, 388, 108, 211, 125, 126, 301, 30, 354, 355, 159, 139, 128, 81, 58, 96, 343, 177, 115, 18, 19, 311, 386, 291, 327, 220, 214, 145, 223, 137, 136, 119, 103, 404, 27, 32, 350, 422, 423, 347, 73, 43, 55, 194, 189, 237, 230, 221, 247, 116, 242, 29, 37, 276, 345, 166, 179, 53, 87, 303, 90, 112, 245, 148, 41, 234, 208, 117, 193, 76, 236, 266, 130, 235, 251, 86, 31, 195, 144, 330, 63, 295, 70, 187, 79, 10, 33, 75, 361, 153, 284, 102, 21, 64, 45, 36, 181, 351, 272, 210, 243, 20, 98, 34, 16, 218;
Apr 8, 2026
View details →Philips respironics, inc.
High PriorityActive
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
All Model No.; All UDI; All Serial No.
Apr 8, 2026
View details →Stryker communications
High PriorityActive
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Surgical light assembly may not adequate support the weight of the ceiling cover.
UDI: 07613327296167; All Lots
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Allura Xper FD20/20; System Code: 722038;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
System Code: 722038; UDI: 00884838054226; System Serial Number: 71, 115, 42, 108, 173, 119, 60, 37, 38, 99, 130, 48, 157, 41, 141, 137, 49, 63, 35, 167, 55, 70, 39, 62, 46, 118, 67, 78, 120, 7, 106, 102, 169, 11, 89, 117, 40, 105, 113, 110, 5, 134, 88, 64, 112, 143, 94, 109, 73, 166, 147, 31, 3, 127, 92, 135, 32, 69, 121, 123, 98, 129, 79, 14, 148, 153, 122, 164, 111, 160, 171, 172, 159, 155, 144, 163, 152, 168, 161, 158, 156, 138, 162, 132, 95, 116, 45, 9, 150, 146, 90, 27, 91, 154, 104, 124, 30, 136, 72, 93, 66, 140, 75, 50, 68, 58, 54, 47, 36, 170, 29;
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Caps.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8CAP; UDI-DI (Product Code): 00840331272185 (CAP8-R8CAP-LG_XL), 00840331272178 (CAP8-R8CAP-SM_MD). 2. Model Number: S8CAP; UDI-DI (Product Code): 00840331272208 (CAP8-S8CAP-LG_XL), 00840331272192 (CAP8-S8CAP-SM_MD). 3.Model Number: U8CAP; UDI-DI (Product Code): 00840331272222 (CAP8-U8CAP-LG_XL), 00840331272215 (CAP8-U8CAP-SM_MD).
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722022; UDI: 00884838059078; System Serial Number: 6; (2) System Code: 722033; UDI: 00884838054233; System Serial Number: 1;
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
1. UDI-DI 10195327501259 (EA) 40195327501250 (CS) LOTS 24DBW065 24EBV301 24HBB492 24JBW143 25ABG413 25CBH359 25DBD213 25GBP569 25HBQ088 25KBF725 26ABE643 2. UDI-DI 10195327371029 (EA) 40195327371020 (CS) LOTS 24FBM018 24GBL319
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Thyroid Shield.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8COPEH; UDI-DI (Product Code): 00840331299052 (COPE-R8COPEH-LG). 2. Model Number: R8TSBBB; UDI-DI (Product Code): 00840331260311 (THYROIDSHIELDO8-R8TSBBB-SM). 3. Model Number: R8TSBBN; UDI-DI: 00840331260328; Codes: THYROIDSHIELDO8-R8TSBBN-LG, THYROIDSHIELDO8-R8TSBBN-MD, THYROIDSHIELDO8-R8TSBBN-SM. 4. Model Number: R8TSBBR; UDI-DI (Product Code): 00840331260359 (THYROIDSHIELDO8-R8TSBBR-LG), 00840331260366 (THYROIDSHIELDO8-R8TSBBR-MD), 00840331260373 (THYROIDSHIELDO8-R8TSBBR-SM). 5. Model Number: R8TSBBT; UDI-DI (Product Code): 00840331260397 (THYROIDSHIELDO8-R8TSBBT-MD), 00840331260403 (THYROIDSHIELDO8-R8TSBBT-SM). 6. Model Number: R8TSBHB; UDI-DI (Product Code): 00840331295948 (THYROIDSHIELDO8-R8TSBHB-MD), 00840331295955 (THYROIDSHIELDO8-R8TSBHB-SM). 7. Model Number: R8TSBHN; UDI-DI (Product Code): 00840331260427 (THYROIDSHIELDO8-R8TSBHN-MD ), 00840331260434 (THYROIDSHIELDO8-R8TSBHN-SM ). 8. Model Number: R8TSBHR; UDI-DI (Product Code): 00840331260465 (THYROIDSHIELDO8-R8TSBHR-SM ), 00840331260458 (THYROIDSHIELDO8-R8TSBHR-MD ), 00840331260441 (THYROIDSHIELDO8-R8TSBHR-LG ). 9. Model Number: R8TSBHT; UDI-DI (Product Code): 00840331260489 (THYROIDSHIELDO8-R8TSBHT-MD ), 00840331260496 (THYROIDSHIELDO8-R8TSBHT-SM ). 10. Model Number: R8TSBMB; UDI-DI (Product Code): 00840331295979 (THYROIDSHIELDOM8-R8TSBMB-MD ), 00840331295986 (THYROIDSHIELDOM8-R8TSBMB-SM ). 11. Model Number: R8TSBMN; UDI-DI (Product Code): 00840331260519 (THYROIDSHIELDOM8-R8TSBMN-MD ). 12. Model Number: R8TSBMR; UDI-DI (Product Code): 00840331260533 (THYROIDSHIELDOM8-R8TSBMR-LG ), 00840331260540 (THYROIDSHIELDOM8-R8TSBMR-MD ), 00840331260557 (THYROIDSHIELDOM8-R8TSBMR-SM ). 13. Model Number: R8TSBMT; UDI-DI (Product Code): 00840331260571 (THYROIDSHIELDOM8-R8TSBMT-MD ). 14. Model Number: R8TSCBB; UDI-DI (Product Code): 00840331270525 (THYROIDSHIELD8-R8TSCBB-LG ), 00840331270532 (THYROIDSHIELD8-R8TSCBB-MD ), 00840331270549 (THYROIDSHIELD8-R8TSCBB-SM ). 15. Model Number: R8TSCBN; UDI-DI (Product Code): 00840331260595 (THYROIDSHIELD8-R8TSCBN-LG ), 00840331260601 (THYROIDSHIELD8-R8TSCBN-MD ), 00840331260618 (THYROIDSHIELD8-R8TSCBN-SM ). 16. Model Number: R8TSCBR; UDI-DI (Product Code): 00840331260625 (THYROIDSHIELD8-R8TSCBR-LG ), 00840331260632 (THYROIDSHIELD8-R8TSCBR-MD ), 00840331260649 (THYROIDSHIELD8-R8TSCBR-SM ). 17. Model Number: R8TSCBS; UDI-DI (Product Code): 00840331270594 (THYROIDSHIELD8-R8TSCBS-MD ), 00840331270587 (THYROIDSHIELD8-R8TSCBS-SM ). 18. Model Number: R8TSCBT; UDI-DI (Product Code): 00840331260656 (THYROIDSHIELD8-R8TSCBT-LG ), 00840331260663 (THYROIDSHIELD8-R8TSCBT-MD ), 00840331260670 (THYROIDSHIELD8-R8TSCBT-SM ). 19. Model Number: R8TSCHB; UDI-DI (Product Code): 00840331270495 (THYROIDSHIELD8-R8TSCHB-LG ), 00840331270501 (THYROIDSHIELD8-R8TSCHB-MD ), 00840331270518 (THYROIDSHIELD8-R8TSCHB-SM ). 20. Model Number: R8TSCHN; UDI-DI (Product Code): 00840331260687 (THYROIDSHIELD8-R8TSCHN-LG ), 00840331260694 (THYROIDSHIELD8-R8TSCHN-MD ), 00840331260700 (THYROIDSHIELD8-R8TSCHN-SM ). 21. Model Number: R8TSCHR; UDI-DI (Product Code): 00840331260717 (THYROIDSHIELD8-R8TSCHR-LG ), 00840331260724 (THYROIDSHIELD8-R8TSCHR-MD ), 00840331260731 (THYROIDSHIELD8-R8TSCHR-SM ). 22. Model Number: R8TSCHS; UDI-DI (Product Code): 00840331270563 (THYROIDSHIELD8-R8TSCHS-MD ), 00840331270556 (THYROIDSHIELD8-R8TSCHS-SM ). 23. Model Number: R8TSCHT; UDI-DI (Product Code): 00840331260748 (THYROIDSHIELD8-R8TSCHT-LG ), 00840331260755 (THYROIDSHIELD8-R8TSCHT-MD ), 00840331260762 (THYROIDSHIELD8-R8TSCHT-SM ). 24. Model Number: R8TSCMB; UDI-DI (Product Code): 00840331270464 (THYROIDSHIELDM8-R8TSCMB-LG ), 00840331270471 (THYROIDSHIELDM8-R8TSCMB-MD ), 00840331270488 (THYROIDSHIELDM8-R8TSCMB-SM ). 25. Model Number: R8TSCMN; UDI-DI (Product Code): 00840331260786 (THYROIDSHIELDM8-R8TSCMN-MD ), 00840331260793 (THYROIDSHIELDM8-R8TSCMN-SM ). 26. Model Number: R8TSCMR; UDI-DI (Product Code): 00840331260809 (THYROIDSHIELDM8-R8TSCMR-LG ), 00840331260816 (THYROIDSHIELDM8-R8TSCMR-MD ), 00840331260823 (THYROIDSHIELDM8-R8TSCMR-SM ). 27. Model Number: R8TSCMS; UDI-DI (Product Code): 00840331260830 (THYROIDSHIELDM8-R8TSCMS-MD ), 00840331260847 (THYROIDSHIELDM8-R8TSCMS-SM ). 28. Model Number: R8TSCMT; UDI-DI (Product Code): 00840331260854 (THYROIDSHIELDM8-R8TSCMT-LG ), 00840331260861 (THYROIDSHIELDM8-R8TSCMT-MD ), 00840331260878 (THYROIDSHIELDM8-R8TSCMT-SM ). 29. Model Number: R8TSOBB; UDI-DI (Product Code): 00840331271430 (THYROIDSHIELDO8-R8TSOBB-MD ). 30. Model Number: R8TSOBN; UDI-DI (Product Code): 00840331260892 (THYROIDSHIELDO8-R8TSOBN-MD ). 31. Model Number: R8TSOBR; UDI-DI (Product Code): 00840331260922 (THYROIDSHIELDO8-R8TSOBR-MD ), 00840331260939 (THYROIDSHIELDO8-R8TSOBR-SM ). 32. Model Number: R8TSOHB; UDI-DI (Product Code): 00840331260939 (THYROIDSHIELDO8-R8TSOHB-MD, THYROIDSHIELDO8-R8TSOHB-SM ). 33. Model Number: R8TSOHR; UDI-DI (Product Code): 00840331261011 (THYROIDSHIELDO8-R8TSOHR-MD ), 00840331261028 (THYROIDSHIELDO8-R8TSOHR-SM ). 34. Model Number: R8TSOHT; UDI-DI (Product Code): 00840331261035 (THYROIDSHIELDO8-R8TSOHT-LG ). 35. Model Number: R8TSOMN; UDI-DI (Product Code): 00840331261080 (THYROIDSHIELDOM8-R8TSOMN-SM ). 36. Model Number: R8TSOMR; UDI-DI (Product Code): 00840331261097 (THYROIDSHIELDOM8-R8TSOMR-LG ), 00840331261103 (THYROIDSHIELDOM8-R8TSOMR-MD ), 00840331261110 (THYROIDSHIELDOM8-R8TSOMR-SM ). 37. Model Number: R8TSOMT; UDI-DI (Product Code): 00840331261141 (THYROIDSHIELDOM8-R8TSOMT-SM ). 38. Model Number: R8TSSBB; UDI-DI (Product Code): 00840331270976 (THYROIDSHIELD8-R8TSSBB-LG ), 00840331270983 (THYROIDSHIELD8-R8TSSBB-MD ), 00840331270990 (THYROIDSHIELD8-R8TSSBB-SM ). 39. Model Number: R8TSSBN ; UDI-DI (Product Code): 00840331261165 (THYROIDSHIELD8-R8TSSBN-MD ), 00840331261172 (THYROIDSHIELD8-R8TSSBN-SM ), None (THYROIDSHIELDP8-R8TSSBN-PD ). 40. Model Number: R8TSSBR; UDI-DI (Product Code): 00840331261189 (THYROIDSHIELD8-R8TSSBR-LG ), 00840331261196 (THYROIDSHIELD8-R8TSSBR-MD ), 00840331261202 (THYROIDSHIELD8-R8TSSBR-SM ). 41. Model Number: R8TSSBS; UDI-DI (Product Code): 00840331271041 (THYROIDSHIELD8-R8TSSBS-MD ), 00840331271034 (THYROIDSHIELD8-R8TSSBS-SM ). 42. Model Number: R8TSSBT; UDI-DI (Product Code): 00840331261226 (THYROIDSHIELD8-R8TSSBT-MD ). 43. Model Number: R8TSSHB; UDI-DI (Product Code): 00840331270952 (THYROIDSHIELD8-R8TSSHB-MD ), 00840331270969 (THYROIDSHIELD8-R8TSSHB-SM ). 44. Model Number: R8TSSHN; UDI-DI (Product Code): 00840331261257 (THYROIDSHIELD8-R8TSSHN-MD ), 00840331261264 (THYROIDSHIELD8-R8TSSHN-SM ). 45. Model Number: R8TSSHR; UDI-DI (Product Code): 00840331261271 (THYROIDSHIELD8-R8TSSHR-LG ), 00840331261288 (THYROIDSHIELD8-R8TSSHR-MD ), 00840331261295 (THYROIDSHIELD8-R8TSSHR-SM ). 46. Model Number: R8TSSHS; UDI-DI (Product Code): 00840331271010 (THYROIDSHIELD8-R8TSSHS-MD ), 00840331271003 (THYROIDSHIELD8-R8TSSHS-SM ). 47. Model Number: R8TSSHT; UDI-DI (Product Code): 00840331261318 (THYROIDSHIELD8-R8TSSHT-MD ), 00840331261325 (THYROIDSHIELD8-R8TSSHT-SM ). 48. Model Number: R8TSSMB; UDI-DI (Product Code): 00840331270921 (THYROIDSHIELDM8-R8TSSMB-MD ), 00840331270938 (THYROIDSHIELDM8-R8TSSMB-SM ). 49. Model Number: R8TSSMN; UDI-DI (Product Code): 00840331261349 (THYROIDSHIELDM8-R8TSSMN-MD ), 00840331261356 (THYROIDSHIELDM8-R8TSSMN-SM ). 50. Model Number: R8TSSMR; UDI-DI (Product Code): 00840331261363 (THYROIDSHIELDM8-R8TSSMR-LG ), 00840331261370 (THYROIDSHIELDM8-R8TSSMR-MD ), 00840331261387 (THYROIDSHIELDM8-R8TSSMR-SM ). 51. Model Number: R8TSSMS; UDI-DI (Product Code): (THYROIDSHIELDM8-R8TSSMS-MD ), (THYROIDSHIELDM8-R8TSSMS-SM ). 52. Model Number: R8TSSMT; UDI-DI (Product Code): 00840331261400 (THYROIDSHIELDM8-R8TSSMT-MD ), 00840331261417 (THYROIDSHIELDM8-R8TSSMT-SM ). 53. Model Number: R8TSVBN; UDI-DI (Product Code): 00840331261431 (THYROIDSHIELD8-R8TSVBN-MD ). 54. Model Number: R8TSVBR; UDI-DI (Product Code): 00840331261462 (THYROIDSHIELD8-R8TSVBR-MD ), 00840331261479 (THYROIDSHIELD8-R8TSVBR-SM ). 55. Model Number: R8TSVHR; UDI-DI (Product Code): 00840331261547 (THYROIDSHIELD8-R8TSVHR-LG ), 00840331261554 (THYROIDSHIELD8-R8TSVHR-MD ), 00840331261561 (THYROIDSHIELD8-R8TSVHR-SM ). 56. Model Number: R8TSVHT; UDI-DI (Product Code): 00840331261561 (THYROIDSHIELD8-R8TSVHT-MD ), 00840331261622 (THYROIDSHIELD8-R8TSVHT-SM ). 57. Model Number: R8TSVMN; UDI-DI (Product Code): 00840331261646 (THYROIDSHIELDM8-R8TSVMN-MD ), 00840331261653 (THYROIDSHIELDM8-R8TSVMN-SM ). 58. Model Number: R8TSVMR; UDI-DI (Product Code): 00840331261660 (THYROIDSHIELDM8-R8TSVMR-LG ), 00840331261677 (THYROIDSHIELDM8-R8TSVMR-MD ), 00840331261684 (THYROIDSHIELDM8-R8TSVMR-SM ). 59. Model Number: R8TSVMT; UDI-DI (Product Code): 00840331261738 (THYROIDSHIELDM8-R8TSVMT-MD ), 00840331261745 (THYROIDSHIELDM8-R8TSVMT-SM ). 60. Model Number: S8TSBHR; UDI-DI (Product Code): 00840331296006 (THYROIDSHIELDO8-S8TSBHR-MD ). 61. Model Number: S8TSBHT; UDI-DI (Product Code): 00840331264197 (THYROIDSHIELDO8-S8TSBHT-LG ). 62. Model Number: S8TSBMB; UDI-DI (Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMB-MD ). 63. Model Number: S8TSBMR; UDI-DI (Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMR-MD ), 00840331264272 (THYROIDSHIELDOM8-S8TSBMR-SM ). 64. Model Number: S8TSCBB; UDI-DI (Product Code): 00840331270693 (THYROIDSHIELD8-S8TSCBB-SM ). 65. Model Number: S8TSCBN; UDI-DI (Product Code): 00840331264326 (THYROIDSHIELD8-S8TSCBN-MD ). 66. Model Number: S8TSCBR; UDI-DI (Product Code): 00840331264340 (THYROIDSHIELD8-S8TSCBR-LG ), 00840331264357 (THYROIDSHIELD8-S8TSCBR-MD ), 00840331264364 (THYROIDSHIELD8-S8TSCBR-SM ). 67. Model Number: S8TSCBT; UDI-DI (Product Code): 00840331264388 (THYROIDSHIELD8-S8TSCBT-MD ), 00840331264395 (THYROIDSHIELD8-S8TSCBT-SM ). 68. Model Number: S8TSCHN; UDI-DI (Product Code): 00840331264401 (THYROIDSHIELD8-S8TSCHN-LG ), 00840331264418 (THYROIDSHIELD8-S8TSCHN-MD ). 69. Model Number: S8TSCHR; UDI-DI (Product Code): 00840331264432 (THYROIDSHIELD8-S8TSCHR-LG ), 00840331264449 (THYROIDSHIELD8-S8TSCHR-MD ), 00840331264456 (THYROIDSHIELD8-S8TSCHR-SM ). 70. Model Number: S8TSCHT; UDI-DI (Product Code): 00840331264470 (THYROIDSHIELD8-S8TSCHT-MD ). 71. Model Number: S8TSCMB; UDI-DI (Product Code): 00840331270617 (THYROIDSHIELDM8-S8TSCMB-LG ). 72. Model Number: S8TSCMN; UDI-DI (Product Code): 00840331264517 (THYROIDSHIELDM8-S8TSCMN-SM ). 73. Model Number: S8TSCMR; UDI-DI (Product Code): 00840331264524 (THYROIDSHIELDM8-S8TSCMR-LG ), 00840331264531 (THYROIDSHIELDM8-S8TSCMR-MD ), 00840331264548 (THYROIDSHIELDM8-S8TSCMR-SM ). 74. Model Number: S8TSCMS; UDI-DI (Product Code): 00840331264555 (THYROIDSHIELDM8-S8TSCMS-MD ), 00840331264562 (THYROIDSHIELDM8-S8TSCMS-SM ). 75. Model Number: S8TSCMT; UDI-DI (Product Code): 00840331264579 (THYROIDSHIELDM8-S8TSCMT-LG ), 00840331264586 (THYROIDSHIELDM8-S8TSCMT-MD ), 00840331264593 (THYROIDSHIELDM8-S8TSCMT-SM ). 76. Model Number: S8TSOBR; UDI-DI (Product Code): 00840331264807 (THYROIDSHIELDO8-S8TSOBR-LG ), 00840331264784 (THYROIDSHIELDO8-S8TSOBR-SM ). 77. Model Number: S8TSSBN; UDI-DI (Product Code): 00840331264883 (THYROIDSHIELD8-S8TSSBN-MD ). 78. Model Number: S8TSSBR; UDI-DI (Product Code): 00840331264906 (THYROIDSHIELD8-S8TSSBR-LG ), 00840331264913 (THYROIDSHIELD8-S8TSSBR-MD ), 00840331264920 (THYROIDSHIELD8-S8TSSBR-SM ). 79. Model Number: S8TSSBT; UDI-DI (Product Code): 00840331264944 (THYROIDSHIELD8-S8TSSBT-MD ). 80. Model Number: S8TSSHR; UDI-DI (Product Code): 00840331264999 (THYROIDSHIELD8-S8TSSHR-LG ), 00840331265002 (THYROIDSHIELD8-S8TSSHR-MD ), 00840331265019 (THYROIDSHIELD8-S8TSSHR-SM ). 81. Model Number: S8TSSHS; UDI-DI (Product Code): 00840331271164 (THYROIDSHIELD8-S8TSSHS-MD ). 82. Model Number: S8TSSHT; UDI-DI (Product Code): 00840331265033 (THYROIDSHIELD8-S8TSSHT-MD ). 83. Model Number: S8TSSMN; UDI-DI (Product Code): 00840331265064 (THYROIDSHIELDM8-S8TSSMN-MD ). 84. Model Number: S8TSSMR; UDI-DI (Product Code): 00840331265088 (THYROIDSHIELDM8-S8TSSMR-LG ), 00840331265095 (THYROIDSHIELDM8-S8TSSMR-MD ), 00840331265101 (THYROIDSHIELDM8-S8TSSMR-SM ). 85. Model Number: S8TSSMS; UDI-DI (Product Code): (THYROIDSHIELDM8-S8TSSMS-MD ). 86. Model Number: S8TSSMT; UDI-DI (Product Code): 00840331265118 (THYROIDSHIELDM8-S8TSSMT-LG ), 00840331265132 (THYROIDSHIELDM8-S8TSSMT-SM ). 87. Model Number: S8TSVBB; UDI-DI (Product Code): 00840331271799 (THYROIDSHIELD8-S8TSVBB-MD ). 88. Model Number: S8TSVBR; UDI-DI (Product Code): 00840331265187 (THYROIDSHIELD8-S8TSVBR-MD ). 89. Model Number: S8TSVHR; UDI-DI (Product Code): 00840331265279 (THYROIDSHIELD8-S8TSVHR-MD ), 00840331265286 (THYROIDSHIELD8-S8TSVHR-SM ). 90. Model Number: S8TSVMR; UDI-DI (Product Code): 00840331265392 (THYROIDSHIELDM8-S8TSVMR-MD ), 00840331265408 (THYROIDSHIELDM8-S8TSVMR-SM ). 91. Model Number: U8TSBBR; UDI-DI (Product Code): 00840331267853 (THYROIDSHIELDO8-U8TSBBR-SM ). 92. Model Number: U8TSBMN; UDI-DI (Product Code): 00840331267990 (THYROIDSHIELDOM8-U8TSBMN-MD ). 93. Model Number: U8TSBMR; UDI-DI (Product Code): 00840331268010 (THYROIDSHIELDOM8-U8TSBMR-LG ), 00840331268027 (THYROIDSHIELDOM8-U8TSBMR-MD ). 94. Model Number: U8TSCBN; UDI-DI (Product Code): 00840331268089 (THYROIDSHIELD8-U8TSCBN-MD ). 95. Model Number: U8TSCBR; UDI-DI (Product Code): 00840331268102 (THYROIDSHIELD8-U8TSCBR-LG ), 00840331268119 (THYROIDSHIELD8-U8TSCBR-MD ), 00840331268126 (THYROIDSHIELD8-U8TSCBR-SM ). 96. Model Number: U8TSCBT; UDI-DI (Product Code): 00840331268140 (THYROIDSHIELD8-U8TSCBT-MD ). 97. Model Number: U8TSCHR; UDI-DI (Product Code): 00840331268201 (THYROIDSHIELD8-U8TSCHR-MD ), 00840331268218 (THYROIDSHIELD8-U8TSCHR-SM ). 98. Model Number: U8TSCMR; UDI-DI (Product Code): 00840331268294 (THYROIDSHIELDM8-U8TSCMR-MD ), 00840331268300 (THYROIDSHIELDM8-U8TSCMR-SM ). 99. Model Number: U8TSCMT; UDI-DI (Product Code): 00840331268324 (THYROIDSHIELDM8-U8TSCMT-MD ), 00840331268331 (THYROIDSHIELDM8-U8TSCMT-SM ). 100. Model Number: U8TSOMR; UDI-DI (Product Code): 00840331268560 (THYROIDSHIELDOM8-U8TSOMR-MD ). 101. Model Number: U8TSSBN; UDI-DI (Product Code): 00840331268621 (THYROIDSHIELD8-U8TSSBN-MD ). 102. Model Number: U8TSSBR; UDI-DI (Product Code): 00840331268652 (THYROIDSHIELD8-U8TSSBR-MD ). 103. Model Number: U8TSSHN; UDI-DI (Product Code): 00840331268713 (THYROIDSHIELD8-U8TSSHN-MD ). 104. Model Number: U8TSSHR; UDI-DI (Product Code): 00840331268737 (THYROIDSHIELD8-U8TSSHR-LG ), 00840331268744 (THYROIDSHIELD8-U8TSSHR-MD ). 105. Model Number: U8TSSMR; UDI-DI (Product Code): 00840331268829 (THYROIDSHIELDM8-U8TSSMR-LG ), 00840331268836 (THYROIDSHIELDM8-U8TSSMR-MD ), 00840331268843 (THYROIDSHIELDM8-U8TSSMR-SM ). 106. Model Number: U8TSSMS; UDI-DI (Product Code): None (THYROIDSHIELDM8-U8TSSMS-SM ). 107. Model Number: U8TSSMT; UDI-DI (Product Code): 00840331268867 (THYROIDSHIELDM8-U8TSSMT-MD ), 00840331268874 (THYROIDSHIELDM8-U8TSSMT-SM ). 108. Model Number: U8TSVMR; UDI-DI (Product Code): 00840331269130 (THYROIDSHIELDM8-U8TSVMR-MD ), 00840331269147 (THYROIDSHIELDM8-U8TSVMR-SM ).
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722005; UDI: N/A; System Serial Number: 321, 285, 490, 51, 298, 329, 49, 361, 323, 355, 456, 316, 169, 305, 565, 419, 269, 258, 346, 474, 497, 530, 261, 523, 384, 388, 271, 233, 367, 270, 427, 343, 399, 360, 212, 251, 112, 520, 70, 392, 128, 357, 485, 405, 306, 307, 467, 234, 287, 333, 533, 209, 369, 543, 332, 328, 366, 389, 538, 394, 378, 379, 237, 165, 238, 2724, 415, 482, 397, 53, 385, 52, 531, 58, 499, 229, 374, 25, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 511, 428, 500, 463, 464, 14, 459, 416, 359, 487, 74, 457, 564, 469, 72, 125, 494, 519, 373, 76; (2) System Code: 722011; UDI: 00884838059047; System Serial Number: 49, 137, 375, 332, 102, 103, 95, 107, 380, 132, 171, 157, 270, 362, 76, 79, 22, 234, 308, 34, 324, 177, 84, 82, 319, 17, 133, 168, 345, 344, 83, 59, 15, 170, 163, 101, 255, 173, 325, 87, 155, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 186, 300, 213, 372, 41, 55, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199, 194, 108, 74, 75, 301, 302, 303, 304, 305, 306, 307, 18, 293, 294, 184, 266, 146, 116, 68, 310, 88, 272, 238, 152, 286, 309, 43, 334, 338, 165, 80, 112, 233, 188, 139, 141, 99, 277, 313, 223, 27, 29, 26, 340, 69, 367, 374, 328, 228, 251, 231, 323, 224, 81, 145, 66, 117, 153, 6, 129, 355, 91, 227, 202, 114, 274, 21, 377, 376, 378, 257, 265, 127, 180, 259, 211, 206, 217, 314, 98, 201, 341, 347, 261, 178, 183, 271, 230, 317, 198, 321, 204, 94, 244, 287, 38, 176, 39, 282, 329, 246, 295, 337, 292, 125; (3) System Code: 722027; UDI: 00884838054196; System Serial Number: 351, 332, 1, 71, 319, 43, 101, 29, 50, 112, 240, 241, 175, 298, 280, 107, 183, 202, 164, 153, 335, 288, 342, 134, 156, 265, 306, 307, 152, 106, 169, 203, 234, 209, 267, 284, 263, 127, 116, 174, 39, 49, 56, 120, 123, 133, 305, 246, 255, 40, 178, 104, 42, 266, 187, 321, 328, 282, 184, 53, 146, 35, 337, 357, 213, 292, 293, 170, 346, 211, 95, 144, 238, 247, 154, 188, 347, 196, 159, 339, 343, 256, 167, 334, 338, 162, 273, 5, 160, 61, 36, 299, 294, 345, 76, 94, 348, 349, 350, 172, 323, 324, 151, 7, 44, 99, 189, 85, 102, 78, 212, 165, 81, 126, 268, 356, 244, 55, 86, 254, 6, 117, 362, 271, 186, 259, 236, 201, 275, 135, 277, 58, 249, 148, 149, 38, 47, 316, 27, 274, 80, 64, 205, 223, 270, 181, 221, 245, 46, 352, 358, 361, 60, 228, 142, 57, 100, 70, 145, 214, 30, 114, 115, 204, 225, 297, 182, 48, 110, 84, 132, 177, 300, 79, 130, 210, 82, 260, 261, 103, 322, 128, 360, 310, 125, 68, 291, 180, 287, 264, 272, 59, 155, 207, 122, 45, 166, 158, 239, 33, 31, 137, 308, 242, 243, 131, 218, 66, 147, 197, 168, 118, 73, 235, 278, 250, 227, 96, 119, 233, 329, 296, 193, 143, 219, 276, 326, 312, 304, 311, 199, 75, 121, 87, 91, 192, 289, 217, 355, 232, 67, 315, 69, 19, 34, 141, 18, 138, 309, 51, 171, 136, 191, 269, 62, 206, 330, 90, 195, 215, 88, 139, 220, 198, 150, 208, 28, 163, 286, 21, 23, 24, 65;
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 770G Insulin Pump: 763000456634, 763000414344, 763000413750, 763000545604, 763000586188, 763000642242, 763000926113, 763000482602, 763000416553, 763000439903, 763000416546, 763000439910, 763000629892, 763000629908, 00763000595906, 763000412685, 763000418151, 763000416546, 763000439903, 763000545499, 763000595906, 763000545505, 763000629892, 763000642235, 763000414344, 763000413750, 763000439866, 763000413750, 763000586195, 763000545604, 763000578640, 76300058618802, 76300058619501, 76300057864002, 76300054560402, 76300058619502, 763000926113: For MiniMed 770G System Users Ages 2-13(M010831C001 1); MiniMed 770G SYSTEM USER GUIDE(M984970A002 1, M978700A002 1, M030281C001 3, M030281C002 1, M811470A261 2, M984970A004 1, M020090C001 3, M020090C002 1, M020090C003 1, M998590A012 2, M998590A003 1, M998590A004 1); MiniMed 770G SYSTEM USER GUIDE mmol/L(M000039C021 1, M811470A021 2).
Apr 8, 2026
View details →Civco medical instruments co. inc.
High PriorityActive
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
UDI-DI: 00841436111034; Lot Number: A228672
Apr 8, 2026
View details →Intuitive surgical, inc.
High PriorityActive
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Lot Code: 420189, Double Fenestrated Grasper GTIN: 00886874111581 FDA Medical Listing Number: D088920 Material Number: 420189-07 Batch / System Numbers: M10120911 SH1182 M10130103 SH1182 M10130116 SH1182 M10130124 SH1182 M10130422 SH1182 M10130731 SH1182 M10130918 SH1182 M10110112 SG704 M10110202 SG704 M10110318 SG704 M10111028 SG704 M20111221 SG704 M10120220 SG704 M10120419 SG704 M10130110 SG704 M10130422 SG704 M10130726 SG704 M10130802 SG704 M10130802 SH0547 M10130918 SH0547 M10110808 SH0059 M10111027 SH0059 M10111104 SH0059 M10121123 SH0059 M10121213 SH0059 M10130103 SH0059 M10130815 SH1557 M10130625 SH1390 M10130731 SH1390 M10130802 SH1390 M10130603 USG721 M10120911 SH0825 M10120727 SH1378 M10121026 SH1378 M10121105 SH1378 M10130121 SH1378 M10130207 SH1378 M10130218 SH1378 M10130322 SH1378 M10130315 SH1378 M10130422 SH1378 M10130603 SH1378 M10130625 SH1378 M10130726 SH1378 M10131010 SH1378 M10110309 SH0729 M10110415 SH0729 M10110621 SH0729 M10110812 SH0729 M10121009 SH0729 M10130103 SH0729 M10130124 SH1622 M10120125 SH1076 M10121113 SH1076 M10130426 SH1604 M10120719 SH1385 M10120727 SH1385 M10120822 SH1385 M10120829 SH2144 M10111104 SH0761 M10120327 SH1276 M10120522 SH1276 M10121026 SH1276 M10130514 SH1276 M10130426 USG518 M10130829 USG518 Material Number: 420189-09 Batch / System Numbers: M10131104 SH1182 M10140228 SH1182 M10140414 SH1182 N10140508 SH1182 N10140619 SH1182 N10140703 SH1182 N10140812 SH1182 N10140902 SH1182 N10141204 SH1182 N10150430 SH1182 N10150814 SH1182 N10150916 SH1182 N10151106 SH1182 N10151119 SH1182 N10160429 SH1182 N10160520 SH1182 N10150825 SH1182 N10160617 SH1182 N10160914 SH1182 N10161012 SH1182 N10161222 SH1182 N10160908 SH1182 N10180105 SH1182 N10140521 SG704 N10140801 SG704 N10141017 SG704 N10150309 SG704 N10150526 SG704 N10150805 SG704 N10160106 SG704 N10160429 SG704 N10160425 SG704 N10160901 SG704 N10170330 SG704 N10171116 SG704 N10171121 SG704 N10150219 SH0547 N10160408 SH0547 M10140324 SH0059 N10140902 SH0059 N10141121 SH0059 N10150227 SH0059 N10150409 SH0059 N10150626 SH0059 N10160901 SH0059 N10160914 SH0059 N10161012 SH0059 N10161122 SH0059 N10171212 SH0059 N10150416 SH1557 N10150727 SH1557 N10160229 SH1557 N10151201 SH1557 N10160520 SH1557 N10160817 SH1557 N10161012 SH1557 N10161122 SH1557 N10170130 SH1557 N10170210 SH1557 N10160825 SH1557 N10170515 SH1557 N10170815 SH1557 N10171116 SH1557 N10171121 SH1557 N10180105 SH1557 M10131108 SH1390 N10141017 SH1390 N10170825 SH1368 N10160525 USG721 N10160808 USG721 M10140327 SH2186 N10140902 SH0825 N10141027 SH0825 N10160114 SH0825 N10161027 SH0825 N10171116 SH0825 M10131025 SH1378 M10131104 SH1378 M10140214 SH1378 M10140324 SH1378 N10140508 SH1378 N10140902 SH1378 N10141030 SH1378 N10141204 SH1378 N10160203 SH1378 N10170330 SH1378 M10140325 SH0729 N10140711 SH0729 N10150122 SH0729 N10150910 SH0729 N10151217 SH0729 N10160509 SH0729 N10160216 SH0035 N10170609 SH0035 M10140327 SH2125 N10140603 SH2125 N10160718 SH2125 N10161209 SH2125 N10171019 SH1604 N10171220 SH1604 N10170531 SH1279 N10170609 SH1279 N10170628 SH1279 N10140711 SH2144 N10150129 SH2144 N10150526 SH2144 N10150727 SH2144 N10151119 SH2144 N10160914 SH2144 N10161222 SH2144 N10171204 SH2144 M10140414 SH1276 N10140603 SH1276 N10150129 USG518 Material Number: 420189-10 Batch / System Numbers: N10180409 SH1182 N10180702 SH1182 N10180509 SG704 N10180223 SH1557 N10180712 SH1557 N12180123 SH0825 N10180409 SH1279 Material Number: 420189-11 Batch / System Numbers: N10190128 SH1182 N10190206 SH1182 N10180814 SH1557 N10181005 SH1557 N10180802 SH1557 N10180928 SH1557 N10190423 SH1557 N10190902 SH1557 N10180814 SH0825 N10190805 SH0825 N10190306 SH2180 N10190128 SH1604 N10180814 SH2144 Material Number: 420189-12 Batch / System Numbers: N10190715 SH1182 N10190502 SH1182 N10190513 SH1182 N10190513 SH1557 N10190408 SH1557 N10190715 SH1557 N10200217 SH1557 N10200803 SH1557 N10201005 SH1557 N10210419 SH1557 N10210210 SH1557 N10200217 SH1964 N10200720 SH1964 N10200427 SH1964 N10210419 SH1964 N10210308 SH1964 N10210713 SH1964 N10200427 SH1604 N10210104 SH1604 N10190502 SH1385 N10210913 SH2144 K10220925 SH2144 K10231026 SH2144
Apr 8, 2026
View details →Summa therapeutics, llc
High PriorityActive
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA
Potential for the balloon in the device to not meet burst specifications.
Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A;
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
Sterile Radiology Procedure Kits, Model Number DYNDH1491B
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
UDI-DI: (CS) 40198459071455, (EA) 10198459071454; Lot Number: 25GBB924
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
1. UDI-DI 10198459629334 (EA) 40198459629335 (CS) LOTS 26AMG895 2. UDI-DI 10198459545283 (EA) 40198459545284 (CS) LOTS 25LBJ366 26ABR365 3. UDI-DI 10195327471859 (EA) 40195327471850 (CS) LOTS 24EBA317 24EBV431 24IBD694 24JBQ783
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Allura Xper FD20/20 OR Table; System Code: 722039;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
System Code: 722039; UDI: 00884838054271; System Serial Number: 4, 2, 5, 8, 6;
Apr 8, 2026
View details →Olympus corporation of the americas
High PriorityActive
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Laser System: TFL-SLS; UDI: 00821925044135; Component Part: TFL-CSLU; UDI: 00821925044593; Serial #: MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456, MDUF230004, MDUF230005, MDUF230006, MDUF230007, MDUF230076, MDUF230140, MDUF230141, MDUF230163, MDUF230164, MDUF230166, MDUF230167, MDUF230234, MDUF230283, MDUF230284, MDUF230331, MDUF230332, MDUF230361, MDUF230362, MDUF230363, MDUF230364, MDUF230365, MDUF230366, MDUF230411, MDUF230412, MDUF230413;
Apr 8, 2026
View details →Philips respironics, inc.
High PriorityActive
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
All Model No.; All UDI; All Serial No.
Apr 8, 2026
View details →Baxter healthcare corporation
High PriorityActive
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
UDI/DI number 00887761984622
Apr 8, 2026
View details →Intuitive surgical, inc.
High PriorityActive
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Lot Code: 420179: Monopolar Curved Scissors (Hot Shears) GTIN: 00886874111505 FDA Medical Number: D088920 Material Number: 420179-10 Batch / System Numbers: M10101102 SH0935 M10101201 SH0935 M10101202 SH1279 M10101203 SH0059 M10101204 USG294 M10101206 USG294 M10101206 SH1378 M10101214 USG022 M10101214 SH0035 M10101214 SH0495 M10110104 SH1279 M10110111 SH1378 M10110112 USG294 M10110113 SH0075 M10110121 SG704 M10110121 SH1279 M10110124 SH0495 M10110126 USG721 M10110126 SH1391 M10110127 USG721 M10110127 SH1279 M10110127 SH2144 M10110202 USG294 M10110202 SH0495 M10110203 SH2144 M10110208 SG704 M10110210 SH1378 M10110216 SH1368 M10110216 USG294 M10110216 SH1391 M10110217 SH0495 M10110217 SH1279 M10110222 SH1279 M10110228 SH0547 M10110228 USG721 M10110228 USG022 M10110228 SH1378 M10110228 SH1279 M10110301 SH1279 M10110303 SH0495 M10110304 USG294 M10110304 SH0729 M10110304 SH0761 M10110307 USG294 M10110308 USG294 M10110308 SH0035 M10110308 SH0495 M10110308 SH1279 M10110311 USG294 M10110311 SH2144 M10110315 USG294 M10110318 USG294 M10110318 SH0935 M10110318 SH1279 M10110323 USG022 M10110324 SH0059 M10110324 USG022 M10110324 SH0495 M10110328 USG294 M10110328 SH0935 M10110328 SH1279 M10110329 USG294 M10110329 SH0935 M10110331 SH0935 M10110405 SH1378 M10110413 USG294 M10110413 SH1279 M10110414 SG704 M10110414 SH0495 M10110420 SH1279 M10110425 SH0035 M10110426 SH0059 M10110428 USG022 M10110429 SG2026 M10110429 SH0035 M10110504 USG294 M10110512 USG294 M10110512 USG022 M10110512 SH2144 M10110517 USG294 M10110517 SH0495 M10110518 SH0035 M10110524 USG294 M10110524 SH1279 M10110525 USG294 M10110526 USG294 M10110526 SH1378 M10110602 SH1279 M10110603 SH1378 M10110614 SH1279 M10110616 SH1368 M10110617 SH1182 M10110617 SH0495 M10110621 SH2144 M10110622 SH0935 M10110623 SH0729 M10110624 SH1378 M10110629 USG294 M10110630 SH1279 M10110630 SH2144 M10110701 SH1378 M10110705 SH0035 M10110711 USG294 M10110712 SH1378 M10110712 SH0495 M10110715 SH1279 M10110715 SH2144 M10110718 SH0761 M10110721 SH0935 M10110728 SH0729 M10110728 SH0761 M10110729 USG721 M10110801 SH1279 M10110802 SH0935 M10110803 USG294 M10110803 USG022 M10110803 SH2144 M10110805 SG704 M10110805 SH0495 M10110808 SH0035 M10110809 USG721 M10110810 SH1279 M10110811 USG022 M10110811 SH0729 M10110812 USG721 M10110812 SH0729 M10110815 SH0935 M10110815 SH1279 M10110816 SG704 M10110816 USG721 M10110816 SH0729 M10110819 USG294 M10110822 SG704 M10110822 USG294 M10110823 SH0729 M10110824 SH0059 M10110824 SH0729 M10110824 SH0495 M10110825 USG721 M10110826 USG721 M10110829 SH1279 M10110830 USG022 M10110902 SG704 M10110902 SH1279 M10110902 SH0761 M10110906 USG022 M10110908 USG721 M10110908 SH1378 M10110908 SH1279 M10110909 SH0495 M10110913 USG721 M10110922 SH2144 M10110923 USG294 M10110923 SH0729 M10110930 SH0935 M10110930 SH0495 M10111003 SG704 M10111004 USG294 M10111005 USG294 M10111006 SH0729 M10111007 SH1368 M10111007 SH0035 M10111007 SH2144 M10111010 SH0935 M10111011 SH0495 M10111011 SH1279 M10111013 SH1378 M10111015 USG022 M10111017 SH1015 M10111018 SH1368 M10111018 SH1279 M10111019 USG294 M10111020 SH0547 M10111020 SH1279 M10111021 USG022 M10111027 SG704 M10111027 SH1378 M10111028 SH0059 M10111028 USG294 M10111028 SH2144 M10111031 SH1015 M10111104 SH1182 M10111107 SH0059 M10111107 SH0729 M10111107 SH0761 M10111108 SH1279 M10111108 SH2144 M10111109 SH0495 M10111111 SH0935 M10111114 USG294 M10111114 SH0729 M10111114 SH1279 M10111115 SG704 M10111115 USG294 M10111115 USG022 M10111116 SH0825 M10111117 SH0729 M10111117 SH1391 M10111117 SH0761 M10111118 SH0935 M10111122 SH0495 M10111122 SH0761 M10111123 SH1390 M10111123 USG294 M10111123 SH0035 M10111124 USG294 M10111129 SH0935 M10111130 SH1378 M10111201 SH1368 M10111202 USG294 M10111202 SH0729 M10111208 USG294 M10111208 SH1279 M10111212 SH1378 M10111213 SG704 M10111213 SH1279 M10111214 USG294 M10111214 SH0729 M10111214 SH1015 M10111216 SH0495 M10111221 USG294 M10111221 SH1378 M10120104 SH1182 M10120104 USG022 M10120104 SH1279 M10120105 USG294 M10120109 USG022 M10120111 SH2144 M10120112 USG721 M10120113 SH0495 M10120117 SH0495 M10120117 SH1279 M10120127 USG294 M10120130 SG704 M10120130 SH1279 M10120131 SH0729 M10120201 SH1390 M10120201 SH0729 M10120203 SH0935 M10120208 SH0729 M10120208 SH1279 M10120208 SH2144 M10120209 SH1378 M10120213 SH0495 M10120214 SH1279 M10120216 SG704 M10120216 SH0495 M10120217 SH1182 M10120217 SH0761 M10120221 SH0729 M10120222 SH1391 M10120224 SH1390 M10120224 USG294 M10120224 SH0729 M10120228 SH1279 M10120301 SH1015 M10120305 SH1279 M10120308 SH0729 M10120309 SH0935 M10120312 USG022 M10120312 SH0935 M10120312 SH1015 M10120313 SH0825 M10120315 SH1279 M10120315 SH2144 M10120316 SH1390 M10120316 SH0729 M10120316 SH1279 M10120317 SH1276 M10120320 SG704 M10120320 SH1368 M10120320 SH1378 M10120320 SH0729 M10120321 SG2026 M10120326 SH1076 M10120327 SH0935 M10120330 SH0059 M10120330 USG294 M10120402 SH1279 M10120403 SH0729 M10120403 SH0495 M10120404 SH1279 M10120409 SH2144 M10120411 SG2026 M10120411 SH2144 M10120412 SH0935 M10120412 SH0761 M10120413 SH1276 M10120416 SH1276 M10120423 USG294 M10120424 USG294 M10120424 SH0035 M10120425 SH1015 M10120425 SH1279 M10120426 SH1390 M10120501 SG704 M10120501 USG721 M10120503 USG022 M10120503 SH0729 M10120503 SH2144 M10120503 SH1276 M10120507 SH1279 M10120515 SH1182 M10120515 SG704 M10120515 USG721 M10120516 SH2144 M10120518 SH1368 M10120521 SH0761 M10120522 USG294 M10120524 USG294 M10120524 SH0729 M10120528 USG294 M10120528 SH1279 M10120529 SH0935 M10120529 SH1276 M10120604 SH0495 M10120606 SH1378 M10120607 SH0547 M10120607 SH0825 M10120612 USG294 M10120612 SH0035 M10120612 SH1279 M10120612 SH0761 M10120614 SH1390 M10120614 SH1368 M10120615 SH0729 M10120622 SG704 M10120622 SH1378 M10120622 SH1015 M10120626 USG294 M10120626 SH1279 M10120627 SH2144 M10120629 USG022 M10120629 SH1378 M10120629 SH0935 M10120629 SH0495 M10120629 SH0761 M10120702 SH0729 M10120702 SH1015 M10120705 SH0059 M10120705 SH1368 M10120705 USG294 M10120705 SH0495 M10120705 SH0761 M10120706 SH0935 M10120706 SH1391 M10120709 SH1390 M10120711 USG294 M10120711 SH1076 M10120713 USG294 M10120713 SH0729 M10120713 SH1279 M10120713 SH2144 M10120713 SH0761 M10120719 USG294 M10120719 SH1279 M10120723 SG704 M10120726 USG721 M10120730 SH0729 M10120730 SH0035 M10120730 SH0761 M10120731 SH1385 M10120801 SH2144 M10120802 SH0059 M10120807 SH1378 M10120808 SH1076 M10120809 SH0729 M10120809 SH1276 M10120810 USG294 M10120813 USG721 M10120815 SH1378 M10120821 SH0935 M10120822 SH1378 M10120822 SH0935 M10120823 USG022 M10120823 SH0729 M10120823 SH0761 M10120827 USG294 M10120828 SH1279 M10120903 SG704 M10120903 SH1276 M10120904 SH0495 M10120906 USG022 M10120911 SH0825 M10120919 SH1276 M10120920 SH0729 M10120920 SH0035 M10120925 SH0495 M10120925 SH1015 M10120928 SH0729 M10121001 SH0059 M10121002 SH1015 M10121004 USG294 M10121004 SH0729 M10121004 SH0495 M10121004 SH1385 M10121006 SH1391 M10121008 SH1279 M10121008 SH0761 M10121010 USG294 M10121012 USG294 M10121015 SH1378 M10121016 SH0495 M10121017 SH2144 M10121019 SH1368 M10121019 SH0825 M10121019 SH0935 M10121023 SH0729 M10121025 USG022 M10121029 SH0729 M10121029 SH1391 M10121029 SH0761 M10121031 USG294 M10121031 SH0935 M10121102 SH1279 M10121106 USG294 M10121106 USG721 M10121112 USG721 M10121113 USG689 M10121114 SG704 M10121114 USG294 M10121115 SH1390 M10121115 USG721 M10121115 SH1391 M10121121 USG294 M10121123 SH0059 M10121123 SH1390 M10121123 SH0495 M10121126 SH0935 M10121128 SH0059 M10121128 SH0729 M10121129 SH1276 M10121204 USG022 M10121205 SH2144 M10121206 SH0059 M10121215 SH1378 M10121215 SH1391 M10121215 SH0495 M10121218 USG294 M10121219 SH0547 M10130102 SH0547 M10130102 SH0059 M10130102 SH1279 M10130104 USG294 M10130108 SH1390 M10130108 USG022 M10130108 SH1279 M10130109 SH1368 M10130110 SH1368 M10130110 SH0935 M10130114 SH0729 M10130115 USG294 M10130116 SH1570 M10130116 SH0935 M10130117 SH0059 M10130117 SH0825 M10130117 SH0729 M10130117 SH0495 M10130118 USG294 M10130121 SH1390 M10130122 USG721 M10130122 SH1015 M10130123 SH1182 M10130124 SH1378 M10130124 SH0761 M10130205 USG022 M10130207 SH1391 M10130207 SH1015 M10130208 SG704 M10130211 USG689 M10130212 SH0729 M10130212 SH0761 M10130213 SH0547 M10130214 SH0729 M10130214 SH0495 M10130215 SH1182 M10130215 SH1378 M10130222 SH1390 M10130227 SH0495 M10130228 SH1622 M10130304 SH0825 M10130304 SH0495 M10130305 SH1570 M10130306 SH0761 M10130306 SH1276 M10130307 USG294 M10130308 SG2026 M10130308 SH1378 M10130308 SH1279 M10130313 USG294 M10130313 SH0935 M10130315 SH2144 M10130315 SH0761 M10130318 SH0059 M10130319 SH1279 M10130319 SH2144 M10130322 SH1279 M10130402 USG022 M10130404 USG022 M10130408 SH1378 M10130408 SH0729 M10130409 SH0059 M10130409 SH0761 M11110225 SG704 M11110323 SH1368 M11110517 SH0729 M11110517 SH1279 M11110517 SH2144 M11110525 SH0761 M11110526 SG704 M11110531 SH0495 M11110602 USG294 M11110602 SH0729 M11110623 SH1368 M11110623 SH1279 M11110625 SH0547 M11110625 USG294 M11110630 SG704 M11110630 USG294 M11110701 USG721 M11110701 SH0495 M11110701 SH0761 M11110808 SH0495 M11110808 SH0761 M11110809 USG294 M11110809 SH1391 M11110809 SH2144 M11110810 SH0761 M11110825 SH0059 M11110825 SH0761 M11110826 SH2144 M11110929 SG2026 M11110929 SH1279 M11111026 SH0729 M11111027 USG294 M11111028 SH0935 M11111028 SH0495 M11111117 USG022 M11111117 SH0729 M11111117 SH0761 M11111124 SH1015 M11111129 USG721 M11111130 USG294 M11111130 SH2144 M11120103 SH0059 M11120103 SH0729 M11120116 USG294 M11120116 SH0495 M11120126 SH0035 M11120127 SH1279 M11120130 USG294 M11120131 SH1182 M11120208 USG294 M11120209 SH0761 M11120210 SH0935 M11120213 SH0729 M11120214 SG2026 M11120330 USG294 M11120402 SH1391 M11120403 USG022 M11120404 SH1279 M11120517 USG294 M11120517 SH1279 M11120522 SH1368 M11120522 SH1276 M11120607 USG294 M11120607 USG022 M11120608 USG022 M11120717 USG294 M11120801 SH1015 M11120813 SH1368 M11120814 SH0729 M11120814 SH1276 M11120816 SH0729 M11120821 USG294 M11120906 SH1378 M11120919 USG689 M11120928 SH0935 M11120928 SH1276 M11121004 USG294 M11121004 SH1015 M11121004 SH1279 M11121010 USG294 M11121011 SH1182 M11121015 SH1378 M11121016 SH2144 M11121114 SH1557 M11121114 SH1378 M11121114 SH0935 M11121114 SH1279 M11121114 SH1276 M11121115 SH1076 M11121116 SH1279 M11121129 USG294 M11121129 SH0761 M11121130 SH0059 M11121203 USG294 M11121205 SH0035 M11121206 SH1604 M11121206 SH1385 M11121211 SG704 M11121211 SH0935 M11121211 SH2144 M11121214 SH1622 M11121218 SH0495 M11121219 SH1279 M11130112 USG294 M11130121 SH1276 M11130124 USG294 M11130124 SH0729 M11130124 SH1279 M11130207 USG721 M11130211 SH1378 M11130213 USG294 M11130214 SH2144 M11130225 SH0729 M11130226 USG721 M11130227 SH0059 M11130227 USG294 M11130228 SH0729 M11130301 SG704 M11130306 SH0059 M11130307 SH1378 M11130315 SH1378 M11130315 SH1391 M11130315 SH1015 M11130322 SH0729 M11130322 SH1276 M11130402 SH1279 M11130404 SH1015 M12110228 SH1279 M12120614 USG294 M12120614 SH1378 M12120801 SH1378 M12120816 SH1279 M12120906 SH1279 M12121011 SH1276 M12121105 SH0495 M12121207 SH1368 M12121211 SH0729 M12130109 SH0495 M12130111 SG704 M12130213 SH1279 M12130221 USG721 M12130226 SH0729 M12130226 SH0035 M12130320 USG294 M12130320 SH0935 M12130320 SH2144 M13120801 SH1390 M13120801 SH0495 M13121206 SH1378 M13130110 USG294 M13130110 SH0761 M13130111 USG721 M13130111 SH0935 M13130112 SH0035 M20111026 SH0935 M20111118 USG294 M20111206 SH0935 M20111206 SH1279 M20120116 USG294 M20120116 SH2144 M20120125 SH1391 M20120125 SH1076 M20120306 SH0495 M20120307 SH0935 M20120307 SH1279 M20120308 SH0035 M20120314 USG294 M20120314 SH0495 M20120514 USG721 M20120514 SH0825 M20120514 SH0729 M20120514 SH1276 S12110708 USG294 Material Number: 420179-12 Batch / System Numbers: M10130601 SH1390 M10130603 SH0825 M10130603 SH0495 M10130605 USG022 M10130605 SH2144 M10130606 SH1570 M10130611 SH1390 M10130612 SH2144 M10130612 SH1276 M10130614 SH0935 M10130619 SG704 M10130620 SH1378 M10130621 SH0729 M10130622 SH1276 M10130703 SH1182 M10130703 SH0035 M10130704 SH2144 M10130710 SH1378 M10130713 SH0729 M10130713 SH1385 M10130713 SH0761 M10130716 SH0761 M10130716 SH1276 M10130717 SG2026 M10130717 SH0935 M10130717 SH1279 M10130718 SH0729 M10130722 USG294 M10130722 SH0761 M10130725 USG022 M10130725 SH1279 M10130726 SH1557 M10130726 USG294 M10130726 SH1391 M10130731 USG294 M10130731 SH0495 M10130801 SH1182 M10130802 SH0495 M10130805 SH0059 M10130805 SH0729 M10130806 USG294 M10130806 SH1391 M10130812 SH1276 M10130814 SH0035 M10130815 SH1378 M10130815 SH0729 M10130815 SH2144 M10130816 SH1570 M10130816 USG721 M10131105 USG294 M10131111 SH0935 M10131111 SH0729 M10131115 USG294 M10131115 SH1279 M10131119 USG022 M10131120 USG294 M10131120 SH1378 M10131120 SH1279 M10131121 SG704 M10131121 USG022 M10131122 SH0935 M10131122 SH0761 M10131123 SH0547 M10131123 SH1837 M10131123 SH1390 M10131128 SH0825 M10131128 SH1378 M10131202 SH0761 M10131202 SH1276 M10131204 SH1604 M10131206 SH1182 M10131206 SH0547 M10131206 SH2144 M10131207 SH0729 M10131207 SH1279 M10131207 SH1276 M10131211 USG294 M10131212 SH0059 M10131212 USG022 M10131212 SH0729 M10131212 SH1279 M10131214 SG704 M10131216 SH0729 M10131217 SH1570 M10131217 SH1557 M10131217 SH0729 M10131217 SH1279 M10131217 SH2144 M10131218 SH1368 M10140108 SH0761 M10140113 SH1378 M10140115 SH1390 M10140115 SH0935 M10140116 SH1557 M10140116 USG721 M10140116 SH1622 M10140117 USG721 M10140120 USG294 M10140120 USG022 M10140123 USG294 M10140123 SH1015 M10140212 SH0547 M10140212 SH1368 M10140212 USG294 M10140212 SH0761 M10140213 SG704 M10140213 SH0729 M10140213 SH0495 M10140213 SH1279 M10140217 SH1276 M10140306 SH1570 M10140328 SH1378 M10140328 SH1391 M10140401 SH1557 M10140401 SH0729 M10140402 SH1385 M10140402 SH1279 M10140416 SH1997 M10140416 SH1391 M11130527 SH1279 M11130603 SH0059 M11130603 SH0729 M11130606 USG721 M11130606 SH1385 M11130607 SH1837 M11130607 SH1279 M11130611 SH0059 M11130613 USG721 M11130613 SH1391 M11130614 SH1570 M11130614 SH1837 M11130618 SH0059 M11130618 SH1390 M11130622 SH1390 M11130622 SH1279 M11130622 SH1276 M11130703 SH1390 M11130708 USG022 M11130709 USG294 M11130710 SH1837 M11130710 SH0935 M11130710 SH1279 M11130711 SH0495 M11130712 USG294 M11130713 SH1368 M11130713 SH0729 M11130716 SH0059 M11130716 SH0729 M11130716 SH2144 M11130718 USG689 M11130718 USG294 M11130722 SH0825 M11130723 SH1378 M11130724 USG294 M11130726 SG704 M11130726 SH1557 M11130726 SH0761 M11130730 SH1390 M11130805 SH1368 M11130805 SG2026 M11130809 USG689 M11130813 SG704 M11130813 USG294 M11130814 SH1837 M11130814 USG022 M11130815 SH0729 M11130815 SH1015 M11130816 USG294 M11130816 SH0729 M11130816 SH1279 M11131111 SH0495 M11131111 USG518 M11131202 USG294 M11131202 SH1378 M11131204 SH0935 M11131205 SH1391 M11131205 SH1279 M11131207 USG721 M11131207 SH0935 M11131207 SH0729 M11131207 SH0495 M11131207 SH2144 M11140108 USG294 M11140108 SH0495 M11140116 SH1378 M11140116 SH1279 M11140211 SH1557 M11140211 SH1378 M11140228 USG721 M11140228 SH1279 M12130531 SH0761 M12130603 SH0729 M12130608 SH0761 M12130610 SG704 M12130611 SH0059 M12130613 USG022 M12130613 SH1391 M12130615 USG518 M12130620 SH0935 M12130620 SH1385 M12130621 SH2144 M12130624 USG294 M12130624 SH1015 M12130702 SH0729 M12130704 SH0495 M12130705 SH1279 M12130708 SH1385 M12130709 SH1276 M12130710 SH1076 M12130710 SH0495 M12130712 USG721 M12130712 SH1385 M12130715 SH0547 M12130715 USG022 M12130717 SH0729 M12130717 SH1391 M12130722 SH0035 M12130726 SG704 M12130726 SH1279 M12130729 SH0729 M12130801 SH1182 M12130802 USG294 M12130802 SH2144 M12130805 SH1557 M12130807 USG294 M12130807 USG022 M12130808 SH1279 M12130809 SH1378 M12130809 SH0761 M12131123 USG689 M13130601 USG294 M13130605 SH0935 M13130605 SH1276 M13130606 SH0035 M13130608 SH0059 M13130613 SH0935 M13130613 SH0035 M13130615 SH1279 M13130617 USG294 M13130620 USG721 M13130621 SH1368 M13130621 SH1378 M13130622 SH1015 M13130624 SH1368 M13130624 SH0761 M13130626 SH0729 M13130702 USG294 M13130703 SH1279 M13130703 SH2144 M13130708 SH1279 M13130712 SH2144 M13130712 SH1276 M13130715 USG721 M13130715 SH1378 M13130715 SH0729 M13130716 USG022 M13130716 SH1076 M13130722 SH1570 M13130722 USG518 M13130724 SH1279 M13130726 USG294 M13130726 SH0825 M13130726 SH0935 M13130731 USG294 M13130731 SH0729 M13130807 SH1378 M13130808 USG294 M13131123 SH1557 M13131123 SH0729 M14130606 SH1391 M14130606 USG518 M14130607 USG294 M14130610 USG294 M14130610 SH0729 M14130613 SH0035 M14130614 SH1622 M14130617 USG294 M14130617 SH0761 M14130620 USG294 M14130620 USG721 M14130621 SH0825 M14130626 SH1570 M14130626 SH1391 M14130702 SH1279 M14130703 USG294 M14130724 SH1015 M14130724 SH1276 M14130725 SH1622 M14130730 USG294 N10130926 SH0495 N10131217 SH1015 N10131217 SH2144 N10140106 SH1015 N10140109 SH1385 N10140110 SH1378 N10140120 SH0729 N10140120 SH1279 N10140120 SH0761 N10140123 SH1378 N10140130 SH0825 N10140130 SH1378 N10140130 SH0935 N10140204 SH1837 N10140204 USG721 N10140204 SH0729 N10140207 SH1276 N10140210 SH0059 N10140210 SH1557 N10140210 USG294 N10140210 SH0729 N10140210 SH2125 N10140211 SH0935 N10140214 SG704 N10140214 USG294 N10140214 SH0495 N10140217 USG294 N10140221 SH0495 N10140224 SH0729 N10140313 USG294 N10140313 SH1378 N10140313 SH0729 N10140313 SH0495 N10140314 SH1557 N10140325 SH0761 N10140401 SH1390 N10140401 SH2186 N10140403 SH1182 N10140403 USG294 N10140408 SH2144 N10140410 SH1378 N10140410 SH0495 N10140410 SH1015 N10140414 USG294 N10140422 USG294 N10140422 SH0761 N10140423 USG294 N10140424 SH1378 N10140425 SH1390 N10140425 USG022 N10140428 SH1015 N10140428 SH1279 N10140428 SH2144 N10140501 USG294 N10140501 SH1391 N10140501 SH2125 N10140501 USG518 N10140507 SH1557 N10140507 SH0729 N10140508 SH0729 N10140512 SH1378 N10140512 SH0935 N10140512 SH1279 N10140513 USG518 N10140514 USG721 N10140519 SH1182 N10140519 USG022 N10140519 SH0495 N10140520 USG721 N10140520 SH0729 N10140523 SH1557 N10140523 SH2144 N10140527 USG721 N10140527 SH1279 N10140530 USG721 N11140204 SH0059 N11140204 USG294 N11140204 SH0729 N11140204 SH0035 N11140314 SH0547 N11140314 USG294 N11140314 USG022 N11140321 USG022 N11140423 SH1378 N11140423 SH2125 N11140428 SH0935 N11140428 SH0761 N11140501 SG704 N11140501 SH0035 N11140501 SH2125 N11140508 SH0059 N11140508 SH0761 N11140509 SH0729 N11140509 SH2144 N11140513 SH0547 N11140514 SH1378 N11140515 SH1279 N11140515 SH0761 N11140516 SH1622 N11140519 SH0547 N11140519 SH1837 N11140521 USG294 N11140526 USG689 N11140526 SH0825 N11140527 SH0729 N11140527 SH1279 N11140529 SH1378 N11140530 SH1076 N12140321 SH1182 N12140325 SH2144 N12140515 SH1378 N13140325 SH0729 N13140424 USG689 S10130603 SH1279 S11130530 SH0761 S11130603 USG294 S11130603 SH1378 Material Number: 420179-14 Batch / System Numbers: N10140620 SH1182 N11140730 SH1182 N13140808 SH1182 N11140904 SH1182 N11150109 SH1182 N11150228 SH1182 N12140620 SH1570 N11140923 SH1570 N11141111 SH1570 N11150228 SH1570 N11140630 SG704 N10140704 SG704 N10140721 SG704 N10140729 SG704 N10140811 SG704 N13140808 SG704 N11140814 SG704 N10140829 SG704 N10140917 SG704 N10140926 SG704 N10141217 SG704 N12141217 SG704 N13150302 SG704 N11140703 SH0547 N10140909 SH0547 N13140909 SH0547 N11141213 SH0547 N10150212 SH0547 N10140617 SH0059 N12140704 SH0059 N10140718 SH0059 N11140820 SH0059 N11140916 SH0059 N10141119 SH0059 N10141125 SH0059 N11150218 SH0059 N11140729 SH1997 N12140620 SH1557 N10140701 SH1557 N10140711 SH1557 N11140724 SH1557 N10140812 SH1557 N11140822 SH1557 N10140828 SH1557 N10140909 SH1557 N10141022 SH1557 N10141111 SH1557 N13141124 SH1557 N11141209 SH1557 N11141213 SH1557 N14141223 SH1557 N10150106 SH1557 N10150115 SH1557 N10150128 SH1557 N11150213 SH1557 N11150219 SH1557 N10150303 SH1557 N10150109 SH1964 N11150218 SH1964 N11140623 SH1837 N10141010 SH1837 N12140612 SH1390 N10140701 SH1390 N10140910 SH1390 N10141206 SH1390 N10150210 SH1390 N13150302 SH1390 N12140612 USG689 N11140701 USG689 N11141001 USG689 N11140806 SH1368 N10141116 SH1368 N12141213 SH1368 N11140610 USG294 N10140620 USG294 N10140701 USG294 N11140701 USG294 N10140711 USG294 N10140718 USG294 N11140730 USG294 N11140731 USG294 N11140820 USG294 N10140829 USG294 N13141023 USG294 N14141023 USG294 N11141104 USG294 N10141201 USG294 N11141210 USG294 N12141213 USG294 N12141217 USG294 N12150121 USG294 N11150123 USG294 N12150212 USG294 N10150219 USG294 N11150228 USG294 N13141125 USG294 N12140710 USG721 N10140806 USG721 N10140814 USG721 N11140829 USG721 N11140901 USG721 N10140903 USG721 N10141029 USG721 N11141103 USG721 N10141211 USG721 N14141223 USG721 N11150211 USG721 N10140701 USG022 N10140703 USG022 N10140806 USG022 N10140814 USG022 N11140917 USG022 N11141211 USG022 N10141213 USG022 N10141218 USG022 N11150115 USG022 N11150209 USG022 N11150211 USG022 N11141110 SH2186 N11141206 SH2186 N12141208 SH2186 N10141218 SH2186 N10140619 SH0825 N11140806 SH0825 N11140903 SH0825 N10141022 SH0825 N14141218 SH0825 N10140620 SH1378 N13140623 SH1378 N10140630 SH1378 N12140704 SH1378 N11140724 SH1378 N10140729 SH1378 N10140909 SH1378 N10140905 SH1378 N11141022 SH1378 N13141023 SH1378 N11141104 SH1378 N10141127 SH1378 N12141129 SH1378 N10141202 SH1378 N11141208 SH1378 N13141218 SH1378 N10141222 SH1378 N11150116 SH1378 N11150219 SH1378 N11150225 SH1378 N10140701 SH0935 N12140710 SH0935 N10140813 SH0935 N13140808 SH0935 N11140909 SH0935 N10141028 SH0935 N10141104 SH0935 N11141208 SH0935 N12141210 SH0935 N11150126 SH0935 N11150204 SH0935 N12150212 SH0935 N12140623 SH0729 N12140704 SH0729 N10140721 SH0729 N10140730 SH0729 N11140729 SH0729 N10140815 SH0729 N10140820 SH0729 N10140904 SH0729 N11140904 SH0729 N10140909 SH0729 N12140910 SH0729 N13141022 SH0729 N11141105 SH0729 N10141127 SH0729 N12141202 SH0729 N11150119 SH0729 N10150109 SH0729 N11150123 SH0729 N11150211 SH0729 N10150224 SH0729 N13150225 SH0729 N10140630 SH0035 N11140801 SH0035 N10141001 SH0035 N11141201 SH0035 N10150218 SH0035 N10140617 SH1391 N13140808 SH1391 N11141129 SH1391 N12150216 SH1391 N13150224 SH1391 N10140607 SH2125 N12141125 SH2125 N10140711 SH1622 N12150121 SH1622 N12140910 SH1076 N11140611 SH1604 N12141023 SH1604 N12141211 SH1604 N10140617 SH0495 N10140703 SH0495 N11140707 SH0495 N10140722 SH0495 N11140812 SH0495 N11140904 SH0495 N10140910 SH0495 N10141103 SH0495 N10141124 SH0495 N11141208 SH0495 N11141217 SH0495 N10141222 SH0495 N11150203 SH0495 N10150225 SH0495 N13150302 SH0495 N10140607 SH1015 N11140612 SH1015 N10140711 SH1015 N11140724 SH1015 N11140926 SH1015 N10141001 SH1015 N10141022 SH1015 N10141106 SH1015 N12141116 SH1015 N10150209 SH1015 N12150216 SH1015 N10150216 SH1015 N13150302 SH1015 N10140619 SH1385 N10140729 SH1385 N12140808 SH1385 N11140917 SH1385 N10141202 SH1385 N10150219 SH1385 N13150302 SH1385 N11140612 SH1279 N10140613 SH1279 N10140620 SH1279 N11140630 SH1279 N11140711 SH1279 N10140718 SH1279 N10140820 SH1279 N13140909 SH1279 N11140926 SH1279 N10141010 SH1279 N10141104 SH1279 N10141110 SH1279 N13141116 SH1279 N12141208 SH1279 N12141211 SH1279 N12141217 SH1279 N10150109 SH1279 N11150218 SH1279 N10150228 SH1279 N11150303 SH1279 N11140610 SH2144 N11140611 SH2144 N10140904 SH2144 N10140903 SH2144 N11140909 SH2144 N10141021 SH2144 N12141116 SH2144 N12141124 SH2144 N11141201 SH2144 N12141222 SH2144 N10150203 SH2144 N10150226 SH2144 N12140630 SH0761 N10140722 SH0761 N11140801 SH0761 N11140923 SH0761 N11141103 SH0761 N11141201 SH0761 N12141213 SH0761 N11141217 SH0761 N12150121 SH0761 N11150211 SH0761 N11140630 SH1276 N11140711 SH1276 N10140806 SH1276 N11140822 SH1276 N10141110 USG518 N10141116 USG518 N12141125 USG518 N10150217 USG518 Material Number: 420179-15 Batch / System Numbers: N11150625 SH1182 N10150810 SH1182 N11150810 SH1182 N10150911 SH1182 N10150916 SH1182 N11150922 SH1182 N10151117 SH1182 N12151202 SH1182 N10160107 SH1182 N10160129 SH1182 N11160309 SH1182 N10160620 SH1182 N12160708 SH1182 N10160715 SH1182 N10161014 SH1182 N11161116 SH1182 N11170106 SH1182 N12170110 SH1182 N10170126 SH1182 N11170217 SH1182 N10170309 SH1182 N11170526 SH1182 N10170626 SH1182 N11170706 SH1182 N11170627 SH1182 N10170830 SH1182 N10171128 SH1182 N10180125 SH1182 N10180222 SH1182 N10180326 SH1182 N10180316 SH1182 N10180424 SH1182 N10150605 SH1570 N10150603 SH1570 N11150825 SH1570 N10151015 SH1570 N10151202 SH1570 N11151216 SH1570 N10160112 SH1570 N10160422 SH1570 N14160725 SH1570 N12160712 SH1570 N10161221 SH1570 N12170309 SH1570 N11170427 SH1570 N10170630 SH1570 N11170609 SH1570 N10180208 SH1570 N10180405 SH1570 N11180220 SH1570 N11150311 SG704 N10150416 SG704 N11150505 SG704 N11150609 SG704 N11150730 SG704 N10150729 SG704 N10150801 SG704 N10151005 SG704 N10151202 SG704 N12151208 SG704 N10151222 SG704 N10160119 SG704 N10160220 SG704 N13160305 SG704 N11160504 SG704 N11160609 SG704 N13160801 SG704 N11160912 SG704 N10161013 SG704 N11161102 SG704 N11170103 SG704 N11170217 SG704 N10170223 SG704 N10170421 SG704 N11170427 SG704 N10170515 SG704 N11170526 SG704 N10170626 SG704 N10170714 SG704 N10170728 SG704 N10171002 SG704 N10171115 SG704 N10171204 SG704 N10171207 SG704 N10180104 SG704 N10180125 SG704 N10180202 SG704 N11180123 SG704 N10180321 SG704 N10180306 SG704 N10180618 SG704 N13150304 SH0547 N12150511 SH0547 N11150519 SH0547 N10150624 SH0547 N10150921 SH0547 N10150923 SH0547 N11151210 SH0547 N13151208 SH0547 N10160210 SH0547 N10160414 SH0547 N10160519 SH0547 N11160614 SH0547 N11160811 SH0547 N11150312 SH0059 N11150401 SH0059 N12150319 SH0059 N10150507 SH0059 N10150519 SH0059 N10150601 SH0059 N10150602 SH0059 N10150623 SH0059 N10150731 SH0059 N10150903 SH0059 N10150929 SH0059 N11151030 SH0059 N10151209 SH0059 N12151202 SH0059 N10151221 SH0059 N11151210 SH0059 N10160718 SH0059 N12160815 SH0059 N13160823 SH0059 N10161020 SH0059 N10161104 SH0059 N10161116 SH0059 N11161117 SH0059 N10170425 SH0059 N10170426 SH0059 N10170509 SH0059 N10170610 SH0059 N10170704 SH0059 N10170717 SH0059 N10170718 SH0059 N10170720 SH0059 N10170926 SH0059 N10171109 SH0059 N10171205 SH0059 N10171215 SH0059 N10171214 SH0059 N10180202 SH0059 N10180509 SH0059 N11180511 SH0059 N11150312 SH1557 N10150330 SH1557 N10150417 SH1557 N11150429 SH1557 N10150526 SH1557 N11150528 SH1557 N10150622 SH1557 N10150803 SH1557 N10150909 SH1557 N11150825 SH1557 N10151009 SH1557 N11151012 SH1557 N12151118 SH1557 N11160116 SH1557 N10160215 SH1557 N10160225 SH1557 N10160408 SH1557 N11160504 SH1557 N10160516 SH1557 N11160606 SH1557 N10160623 SH1557 N11160614 SH1557 N11160715 SH1557 N11160808 SH1557 N13160823 SH1557 N11160930 SH1557 N12160930 SH1557 N10161128 SH1557 N11161202 SH1557 N10161219 SH1557 N10170201 SH1557 N11170120 SH1557 N10170225 SH1557 N12170404 SH1557 N11170421 SH1557 N10170509 SH1557 N11170526 SH1557 N10170606 SH1557 N10170706 SH1557 N10170718 SH1557 N10170810 SH1557 N10170815 SH1557 N10171011 SH1557 N10171023 SH1557 N10171117 SH1557 N10180123 SH1557 N10180202 SH1557 N10180216 SH1557 N10180302 SH1557 N11180413 SH1557 N10180423 SH1557 N10180306 SH1557 N10180418 SH1557 N10150427 SH1964 N11150429 SH1964 N10150622 SH1964 N11150626 SH1964 N11150728 SH1964 N10150814 SH1964 N10151014 SH1964 N11150928 SH1964 N10151102 SH1964 N10160106 SH1964 N10160303 SH1964 N10160321 SH1964 N10160505 SH1964 N10160705 SH1964 N11160809 SH1964 N10161028 SH1964 N11161107 SH1964 N11161125 SH1964 N10170309 SH1964 N10170404 SH1964 N10170519 SH1964 N10170526 SH1964 N11170620 SH1964 N10170707 SH1964 N11170906 SH1964 N10171101 SH1964 N10180119 SH1964 N10180201 SH1964 N10180209 SH1964 N10180122 SH1964 N10180322 SH1964 N10180706 SH1964 N11150622 SH1837 N12150725 SH1837 N10150804 SH1837 N10150714 SH1837 N10160105 SH1837 N12160831 SH1837 N12161014 SH1837 N10161128 SH1837 N10170913 SH1837 N10171020 SH1837 N10180219 SH1837 N11180511 SH1837 N10180301 SH1822 N13150318 SH1390 N10150518 SH1390 N10150624 SH1390 N10150623 SH1390 N10151009 SH1390 N10151028 SH1390 N12151202 SH1390 N11160225 SH1390 N12160305 SH1390 N11160419 SH1390 N11160428 SH1390 N10160628 SH1390 N11160725 SH1390 N11160714 SH1390 N13160830 SH1390 N13160815 SH1390 N11161010 SH1390 N11161028 SH1390 N10161124 SH1390 N11161223 SH1390 N11170421 SH1390 N10170505 SH1390 N10170612 SH1390 N10170707 SH1390 N10171027 SH1390 N10171101 SH1390 N10180112 SH1390 N10180215 SH1390 N10180302 SH1390 N10180306 SH1390 N10150325 USG689 N10150630 USG689 N12150525 USG689 N10150729 USG689 N10150814 USG689 N10150904 USG689 N10160415 USG689 N10160512 USG689 N11160901 USG689 N10161003 USG689 N10170202 USG689 N10170209 USG689 N12170304 USG689 N11171221 USG689 N10171214 USG689 N10180326 USG689 N10180503 USG689 N10150422 SH1368 N11150708 SH1368 N10150730 SH1368 N11150922 SH1368 N10160106 SH1368 N11160213 SH1368 N10160317 SH1368 N11160418 SH1368 N10170116 SH1368 N11170517 SH1368 N11171220 SH1368 N10171214 SH1368 N10180413 SH1368 N10180504 SH1368 N11150306 USG294 N10150324 USG294 N10150326 USG294 N11150407 USG294 N13150318 USG294 N11150416 USG294 N10150424 USG294 N11150505 USG294 N11150519 USG294 N10150528 USG294 N11150529 USG294 N10150616 USG294 N12150609 USG294 N10150708 USG294 N10150727 USG294 N10150804 USG294 N10150810 USG294 N10150824 USG294 N10150902 USG294 N10150909 USG294 N10150916 USG294 N11150824 USG294 N10151005 USG294 N11151013 USG294 N12150820 USG294 N11151014 USG294 N11151030 USG294 N10151203 USG294 N12151006 USG294 N11151208 USG294 N10151216 USG294 N10160104 USG294 N12160116 USG294 N11160128 USG294 N10160210 USG294 N10160213 USG294 N10160301 USG294 N10160307 USG294 N11160312 USG294 N10160321 USG294 N11160330 USG294 N10160422 USG294 N10160505 USG294 N10160512 USG294 N10160517 USG294 N10160613 USG294 N10160623 USG294 N10160630 USG294 N10160714 USG294 N13160803 USG294 N11160809 USG294 N11160815 USG294 N11160818 USG294 N11160906 USG294 N14160815 USG294 N10160930 USG294 N14160913 USG294 N10161010 USG294 N10161021 USG294 N10161014 USG294 N11161124 USG294 N10160915 USG294 N11170103 USG294 N10170117 USG294 N11170126 USG294 N11170120 USG294 N11170309 USG294 N11170327 USG294 N10170330 USG294 N11170427 USG294 N10170428 USG294 N10170427 USG294 N10170511 USG294 N10170607 USG294 N11170606 USG294 N10170610 USG294 N10170620 USG294 N12170610 USG294 N10170707 USG294 N10170720 USG294 N10170803 USG294 N10170810 USG294 N10170901 USG294 N10170907 USG294 N10170929 USG294 N10171030 USG294 N10171128 USG294 N10171207 USG294 N10171219 USG294 N10180119 USG294 N10180130 USG294 N11180123 USG294 N10180209 USG294 N10180314 USG294 N10180326 USG294 N10180413 USG294 N10180424 USG294 N10180316 USG294 N11180423 USG294 N10180306 USG294 N10180510 USG294 N10150304 USG721 N11150312 USG721 N10150325 USG721 N10150602 USG721 N10150608 USG721 N11150622 USG721 N11150625 USG721 N12150725 USG721 N11150814 USG721 N10151019 USG721 N10150725 USG721 N11151110 USG721 N11151205 USG721 N12151202 USG721 N10151210 USG721 N11160513 USG721 N10160601 USG721 N10160606 USG721 N10160609 USG721 N10161020 USG721 N10161026 USG721 N11161007 USG721 N11161020 USG721 N10161128 USG721 N11160921 USG721 N11161214 USG721 N10170105 USG721 N11170213 USG721 N10170228 USG721 N10170224 USG721 N10170426 USG721 N10170512 USG721 N10170519 USG721 N10170620 USG721 N11170627 USG721 N10170720 USG721 N10170726 USG721 N10170810 USG721 N10170817 USG721 N10170815 USG721 N10171025 USG721 N10171026 USG721 N10171124 USG721 N10171206 USG721 N10180104 USG721 N10180131 USG721 N10180207 USG721 N10180301 USG721 N10180216 USG721 N11180103 USG721 N10180220 USG721 N10150428 USG022 N13150427 USG022 N10150603 USG022 N10150622 USG022 N10150623 USG022 N12150806 USG022 N10150923 USG022 N10151118 USG022 N13151204 USG022 N10160206 USG022 N11160310 USG022 N10160316 USG022 N10160419 USG022 N10160531 USG022 N11160615 USG022 N11160725 USG022 N10160830 USG022 N11160927 USG022 N10161028 USG022 N11161107 USG022 N10161122 USG022 N11170120 USG022 N11170403 USG022 N10170504 USG022 N10170515 USG022 N11160811 USG022 N10170626 USG022 N11170706 USG022 N10170720 USG022 N11170814 USG022 N10171017 USG022 N10171101 USG022 N11171221 USG022 N10171214 USG022 N10180504 USG022 N10180322 USG022 N10150605 SH2186 N10150624 SH2186 N10151106 SH2186 N12151202 SH2186 N11160513 SH2186 N10160705 SH2186 N12170225 SH2186 N10170404 SH2186 N10170530 SH2186 N10171023 SH2186 N10171128 SH2186 N10180426 SH2186 N12150511 SH0825 N11150820 SH0825 N11151205 SH0825 N11160120 SH0825 N10160303 SH0825 N14160725 SH0825 N10160809 SH0825 N14160815 SH0825 N11160923 SH0825 N10161031 SH0825 N10170311 SH0825 N10170526 SH0825 N10170630 SH0825 N10171215 SH0825 N10180129 SH0825 N10180328 SH0825 N10150312 SH1378 N10150318 SH1378 N10150506 SH1378 N11150525 SH1378 N10150529 SH1378 N11150529 SH1378 N10150624 SH1378 N10150623 SH1378 N10150908 SH1378 N10150915 SH1378 N10150929 SH1378 N10151016 SH1378 N10150714 SH1378 N12151006 SH1378 N12151202 SH1378 N10160212 SH1378 N10160301 SH1378 N10160308 SH1378 N12160305 SH1378 N10160328 SH1378 N10160421 SH1378
Apr 8, 2026
View details →Civco medical instruments co. inc.
High PriorityActive
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
UDI-DI: 00841436111096; Lot Number: A276636, A282454
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Blockers.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8BLOCKER1; UDI-DI (Product Code): 00840331272895 (BLOCKER8-R8BLOCKER1). 2. Model Number: R8BLOCKER2; UDI-DI (Product Code): 00840331272901 (BLOCKER8-R8BLOCKER2). 3. Model Number: R8BLOCKER3; UDI-DI (Product Code): 00840331272918 (BLOCKER8-R8BLOCKER3). 4. Model Number: R8BLOCKER4; UDI-DI (Product Code): 00840331272932 (BLOCKER8-R8BLOCKER4). 5. Model Number: R8BLOCKER5; UDI-DI (Product Code): 00840331272949 (BLOCKER8-R8BLOCKER5). 6. Model Number: R8BLOCKER6; UDI-DI (Product Code): 00840331272956 (BLOCKER8-R8BLOCKER6). 7. Model Number: S8BLOCKER1; UDI-DI (Product Code): 00840331272963 (BLOCKER8-S8BLOCKER1). 8. Model Number: S8BLOCKER2; UDI-DI (Product Code): 00840331272970 (BLOCKER8-S8BLOCKER2). 9. Model Number: S8BLOCKER3; UDI-DI (Product Code): 00840331272987 (BLOCKER8-S8BLOCKER3). 10. Model Number: U8BLOCKER1; UDI-DI (Product Code): 00840331273038 (BLOCKER8-U8BLOCKER1).
Apr 8, 2026
View details →Philips respironics, inc.
High PriorityActive
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
All Model No.; All UDI; All Serial No.
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722228; UDI: 00884838099234; System Serial Number: 67, 524, 49, 678, 679, 10, 36, 64, 110, 403, 328, 481, 373, 149, 213, 45, 537, 615, 159, 18, 231, 180, 61, 204, 273, 538, 76, 502, 150, 132, 399, 533, 211, 17, 47, 38, 87, 617, 618, 619, 128, 522, 32, 600, 23, 25, 62, 177, 181, 48, 189, 153, 79, 80, 157, 24, 187, 26, 642, 431, 29, 113, 122, 127, 6, 123, 124, 185, 186, 198, 92, 215, 573, 91, 529, 523, 205, 20, 37, 659, 145, 3, 567, 539, 645, 156, 308, 333, 335, 570, 560, 44, 569, 418, 525, 280, 616, 387, 568, 471, 428, 465, 556, 629, 102, 103, 176, 178, 109, 16, 299, 234, 566, 508, 571, 463, 71, 493, 1, 434, 647, 317, 562, 230, 293, 552, 457, 458, 369, 561, 517, 203, 554, 260, 100, 101, 107, 108, 640, 99, 318, 21, 22, 676, 677, 154, 531, 75, 602, 78, 574, 158, 461, 370, 613, 393, 564, 482, 194, 660, 673, 60, 464, 4, 462, 138, 223, 312, 319, 98, 623, 475, 125, 218, 513, 442, 435, 9, 95, 557, 174, 548, 486, 487, 84, 454, 346, 396, 39, 339, 172, 191, 327, 52, 575, 196, 406, 118, 415, 436, 114, 452, 53, 216, 761, 179, 398, 31, 88, 331, 297, 392, 374, 503, 412, 385, 343, 427, 488, 389, 349, 536, 214, 232, 500, 713, 622, 727, 469, 588, 365, 443, 510, 757, 758, 692, 747, 705, 414, 712, 728, 621, 710, 715, 726, 717, 90, 706, 417, 709, 498, 729, 130, 707, 714, 718, 755, 711, 716, 750, 708, 744, 704, 284, 663, 725, 565, 745, 73, 474, 724, 735, 703, 201, 407, 397, 104, 202, 690, 46, 171, 34, 70, 680, 657, 229, 259, 332, 643, 501, 286, 306, 610, 117, 646, 13, 395, 429, 12, 56, 654, 460, 601, 579, 57, 86, 665, 628, 257, 607, 608, 430, 360, 650, 651, 590, 591, 595, 352, 329, 197, 366, 345, 627, 302, 166, 664, 432, 361, 305, 542, 313, 620, 220, 325, 545, 405, 514, 433, 341, 342, 184, 424, 425, 426, 497, 630, 258, 183, 195, 314, 555, 626, 282, 402, 490, 439, 421, 440, 446, 338, 472, 662, 689, 633, 320, 281, 480, 631, 364, 581, 182, 448, 283, 291, 473, 321, 476, 681, 409, 535, 376, 606, 519, 655, 384, 534, 362, 520, 489, 592, 303, 413, 496, 580, 668, 106, 63, 685, 691, 701, 722, 723, 730, 732, 733, 765, 35, 512, 404, 74, 437, 614, 546, 14, 336, 200, 344, 356, 357, 394, 7, 504, 190, 377, 383, 193, 94, 89, 93, 309, 310, 494, 444, 199, 667, 391, 408, 532, 698, 83, 143, 518, 85, 483, 449, 337, 438, 453, 311, 324, 639, 353, 459, 5, 43, 477, 330, 386, 288, 167, 549, 390, 368, 192, 66, 115, 116, 334, 467, 307, 304, 350, 212, 340, 348, 506, 516, 515, 292, 33, 173, 543, 217, 219, 160, 702, 634, 82, 135, 133, 208, 478, 162, 165, 635, 597, 378, 466, 163, 168, 479, 164, 81, 228, 401, 688, 97, 719, 139, 540, 121, 147, 354, 141, 734, 285, 720, 65, 140, 598, 294, 146, 175, 170, 637, 295, 290, 134, 136, 316, 289, 207, 686, 492, 416, 298, 30, 59, 419, 11, 119, 28, 144, 68, 55, 27, 233, 611; (2) System Code: 722232; UDI: 00884838116757; System Serial Number: 5, 33, 34, 106, 49, 138, 91, 2, 95, 96, 36, 23, 108, 42, 48, 46, 76, 6, 60, 61, 10, 43, 97, 8, 113, 118, 119, 139, 22, 50, 75, 63, 130, 132, 89, 86, 69, 3, 67, 39, 4, 44, 122, 123, 71, 72, 110, 93, 1, 68, 11, 77, 20, 7, 57, 58, 260, 115, 14, 82, 70, 112, 81, 131, 277, 128, 31, 37, 120, 121, 35, 293, 28, 30, 54, 102, 19, 134, 137, 29, 56, 51, 32, 105, 16, 117, 73, 100, 13; (3) System Code: 722281; UDI: 00884838110564; System Serial Number: 125, 176, 233, 296, 74, 284, 55, 81, 37, 21, 135, 278, 390, 179, 181, 182, 282, 286, 357, 358, 359, 109, 136, 93, 153, 247, 27, 28, 299, 76, 140, 60, 341, 310, 192, 275, 127, 108, 254, 255, 24, 20, 129, 343, 295, 215, 66, 98, 48, 235, 378, 145, 336, 115, 348, 120, 17, 12, 65, 217, 339, 351, 95, 364, 236, 308, 44, 45, 319, 164, 124, 159, 317, 318, 64, 189, 71, 38, 387, 228, 272, 54, 19, 26, 105, 344, 259, 260, 261, 316, 80, 265, 70, 190, 225, 186, 180, 281, 202, 349, 149, 117, 388, 52, 175, 187, 270, 11, 219, 371, 269, 157, 290, 102, 244, 94, 110, 23, 9, 208, 209, 168, 204, 114, 253, 35, 155, 199, 201, 161, 126, 211, 287, 207, 85, 321, 227, 276, 226, 169, 156, 258, 170, 415, 294, 101, 229, 146, 14, 88, 99, 188, 89, 273, 340, 68, 151, 141, 221, 33, 307, 350, 289, 246, 83, 10, 177, 39, 40, 43, 326, 331, 57, 212, 304, 122, 178, 367, 323, 69, 191, 50, 13, 61, 194, 200, 250, 251, 34, 132, 404, 325, 205, 82, 222, 138, 174, 311, 312, 121, 300, 90, 96, 231, 123, 298, 160, 335, 75, 91, 292, 369, 223, 18, 86, 87, 49, 385, 166, 72, 274, 47, 242, 324, 144, 355, 158, 234, 345, 22, 224, 197, 198, 206, 329, 118, 249, 58, 133, 263, 193, 280, 137, 303, 302, 103, 353, 196, 139, 173, 143, 29, 239, 15, 163, 172, 111, 252, 230, 42, 213, 220, 346, 347, 362, 185, 30, 31, 25, 106, 142, 36, 84, 16, 257, 241, 243, 262, 165, 147, 248, 288;
Apr 8, 2026
View details →Mentor texas, lp.
High PriorityActive
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
Apr 8, 2026
View details →Philips respironics, inc.
High PriorityActive
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
All Model No.; All UDI; All Serial No.
Apr 8, 2026
View details →Reflexion medical, inc.
High PriorityActive
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
Software Version: 2.1.29-4 and Software Version: 2.1.35-1. UDI: (01)00860003983812(11)230504(21)X11001, (01)00860003983812(11)230518(21)X11002, (01)00860003983812(11)230505(21)X11003, (01)00860003983812(11)230530(21)X11004, (01)00860003983812(11)230811(21)X11006, (01)00860003983812(11)230410(21)X11007, (01)00860003983812(11)230803(21)X11008, (01)00860003983812(11)240528(21)X11009, (01)00860003983812(11)240820(21)X11010, (01)00860003983812(11)241107(21)X11011, (01)00860003983812(11)241206(21)X11012, (01)00860003983812(11)250731(21)X11013.
Apr 8, 2026
View details →Mentor texas, lp.
High PriorityActive
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
10081317028359 10081317028366 10081317028373 10081317028380 10081317028397 10081317028403
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722078; UDI: 00884838085251; System Serial Number: 302, 585, 410, 753, 523, 293, 840, 291, 536, 537, 870, 613, 598, 679, 224, 829, 249, 546, 478, 479, 513, 278, 437, 438, 456, 566, 833, 488, 327, 550, 571, 544, 545, 465, 376, 31, 921, 700, 165, 445, 539, 654, 656, 657, 658, 436, 1007, 862, 786, 308, 396, 576, 121, 239, 383, 491, 125, 500, 645, 379, 399, 803, 415, 296, 136, 890, 626, 697, 559, 532, 538, 185, 166, 257, 258, 684, 359, 143, 661, 824, 649, 493, 720, 520, 521, 556, 557, 558, 187, 902, 269, 317, 522, 611, 677, 709, 535, 170, 723, 251, 298, 22, 305, 725, 728, 524, 290, 441, 384, 480, 481, 364, 294, 906, 240, 256, 603, 289, 719, 163, 215, 271, 788, 412, 627, 141, 644, 292, 844, 876, 748, 483, 497, 309, 232, 425, 635, 612, 797, 247, 733, 162, 517, 888, 923, 204, 205, 206, 195, 197, 218, 444, 986, 561, 503, 689, 499, 135, 589, 38, 977, 738, 476, 380, 453, 24, 690, 356, 343, 344, 174, 898, 482, 378, 764, 693, 694, 770, 771, 772, 773, 439, 191, 938, 980, 981, 982, 307, 628, 235, 139, 178, 179, 265, 266, 511, 526, 746, 264, 287, 361, 362, 1003, 348, 897, 845, 960, 1036, 967, 374, 375, 564, 142, 469, 934, 565, 835, 836, 929, 975, 681, 1069, 1070, 1071, 1072, 893, 1061, 382, 324, 604, 713, 114, 849, 326, 659, 346, 347, 26, 621, 553, 325, 648, 1058, 1068, 339, 340, 414, 687, 688, 237, 958, 751, 881, 698, 610, 20, 846, 625, 424, 800, 838, 590, 150, 762, 485, 726, 727, 1039, 847, 959, 962, 865, 180, 371, 769, 570, 572, 1031, 792, 702, 196, 28, 29, 683, 541, 213, 320, 1025, 943, 651, 722, 242, 36, 431, 672, 177, 578, 912, 355, 504, 699, 270, 306, 190, 366, 52, 398, 470, 562, 489, 147, 160, 743, 152, 759, 630, 729, 151, 334, 815, 429, 449, 757, 506, 703, 149, 818, 647, 419, 328, 584, 223, 192, 779, 468, 222, 200, 134, 262, 855, 284, 918, 919, 277, 976, 13, 15, 502, 817, 795, 498, 574, 577, 254, 255, 448, 27, 631, 632, 599, 370, 216, 451, 428, 467, 450, 102, 662, 189, 633, 512, 175, 796, 459, 460, 718, 462, 464, 891, 768, 263, 944, 669, 112, 23, 452, 338, 367, 440, 490, 181, 145, 250, 705, 49, 50, 51, 617, 336, 226, 761, 220, 221, 1037, 799, 839, 354, 153, 154, 957, 471, 357, 130, 132, 133, 261, 695, 158, 507, 854, 477, 785, 789, 404, 877, 806, 422, 194, 801, 802, 140, 608, 878, 952, 10, 123, 319, 686, 805, 397, 127, 128, 253, 594, 988, 300, 301, 321, 332, 35, 17, 341, 563, 314, 316, 496, 641, 953, 30, 950, 331, 652, 1005, 349, 236, 979, 831, 501, 841, 842, 905, 682, 843, 830, 323, 315, 680, 365, 282, 283, 602, 203, 202, 40, 673, 674, 675, 676, 609, 295, 368, 369, 615, 618, 310, 199, 455, 668, 352, 193, 280, 667, 884, 567, 183, 749, 692, 32, 241, 935, 407, 408, 505, 138, 157, 752, 461, 463, 423, 554, 252, 169, 426, 650, 351, 442, 750, 968, 207, 208, 209, 210, 211, 622, 623, 629, 129, 529, 144, 400, 401, 411, 259, 457, 579, 926, 597, 899, 322, 978, 173, 418, 637, 670, 909, 601, 37, 1033, 1035, 227, 1009, 1008, 989, 984, 987, 907, 1081, 1004, 1086, 1084, 1085, 1048, 1059, 1034, 1080, 1015, 875, 1026, 1077, 716, 717, 1045, 940, 942, 945, 946, 947, 948, 1052, 971, 1062, 1063, 994, 701, 993, 620, 1075, 1046, 970, 985, 798, 1074, 856, 710, 1011, 1064, 1065, 1066, 1067, 1000, 1056, 992, 663, 1057, 964, 965, 1043, 735, 736, 819, 820, 272, 1049, 1073, 1079, 712, 714, 732, 774, 381, 233, 638, 318, 593, 624, 775, 776, 21, 267, 268, 487, 421, 760, 542, 614, 864, 148, 837, 458, 596, 377, 281, 784, 991, 528, 42, 44, 45, 41, 43, 466, 704, 219, 217, 260, 103, 430, 342, 126, 184, 778, 547, 586, 879, 159, 363, 896, 642, 472, 39, 172, 782, 961, 33, 643, 581, 552, 525, 311, 312, 510, 857, 731, 432, 433, 636, 954, 447, 333, 358, 540, 619, 492, 527, 600, 816, 434, 892, 990, 124, 122, 146, 201, 509, 495, 515, 353, 303, 304, 186, 286, 548, 518, 486, 474, 475, 1047, 853, 243, 244, 335, 549, 46, 616, 972, 533, 777, 182, 1032, 1051, 850, 696, 345, 575, 939, 869, 874, 871, 1010, 1029, 1030, 18, 551, 1013, 917, 543, 516, 12, 416, 155, 446, 685, 715, 225, 1082, 913, 582, 908, 19, 435, 16, 11, 167, 664, 901, 508, 530, 198; (2) System Code: 722223; UDI: 00884838099241; System Serial Number: 312, 324, 332, 585, 85, 533, 189, 479, 1038, 47, 1146, 352, 391, 328, 681, 1052, 1130, 388, 581, 855, 905, 570, 77, 448, 495, 571, 171, 1051, 439, 126, 628, 36, 1088, 580, 1179, 1241, 1065, 799, 577, 1060, 1107, 1114, 323, 252, 626, 261, 207, 329, 1001, 801, 560, 561, 205, 379, 440, 204, 192, 197, 177, 37, 340, 1097, 282, 357, 1015, 214, 44, 206, 210, 336, 1231, 343, 365, 390, 1067, 1106, 1144, 186, 187, 631, 87, 373, 514, 599, 601, 602, 69, 638, 728, 937, 944, 945, 951, 852, 256, 679, 596, 67, 932, 503, 432, 131, 301, 456, 704, 659, 242, 746, 1161, 1090, 1265, 455, 457, 221, 454, 829, 816, 318, 229, 230, 262, 308, 637, 124, 198, 433, 883, 889, 566, 1084, 880, 665, 188, 367, 52, 371, 892, 127, 105, 572, 104, 334, 627, 458, 1113, 463, 487, 470, 96, 277, 616, 1140, 211, 850, 223, 1242, 872, 877, 97, 1211, 161, 1132, 386, 1123, 208, 1061, 361, 258, 597, 727, 1008, 1296, 180, 1181, 835, 668, 377, 882, 565, 1103, 196, 130, 1185, 1150, 886, 887, 452, 453, 269, 888, 1188, 567, 966, 449, 435, 441, 669, 351, 508, 750, 164, 139, 355, 619, 1236, 133, 89, 370, 598, 714, 119, 1306, 1307, 871, 697, 698, 1035, 1036, 116, 154, 100, 912, 99, 349, 387, 136, 775, 903, 867, 680, 527, 1227, 629, 1264, 834, 1226, 155, 837, 17, 18, 804, 235, 249, 477, 1025, 1177, 1153, 1210, 167, 1290, 1293, 227, 965, 999, 46, 1131, 141, 1282, 1005, 1129, 1115, 237, 348, 287, 1325, 135, 414, 416, 417, 132, 814, 836, 1245, 356, 809, 810, 303, 1214, 1099, 813, 1167, 1232, 1248, 322, 587, 591, 812, 875, 904, 756, 516, 917, 1016, 10, 1256, 537, 582, 694, 1055, 576, 134, 247, 961, 963, 1222, 1217, 1272, 584, 7, 923, 933, 709, 193, 128, 393, 434, 615, 1165, 854, 550, 657, 1283, 1196, 1258, 407, 1212, 612, 926, 353, 398, 555, 848, 931, 213, 364, 909, 910, 918, 916, 265, 1243, 142, 168, 518, 476, 671, 683, 302, 863, 864, 1033, 894, 25, 1295, 482, 919, 693, 553, 1191, 868, 114, 191, 409, 106, 506, 232, 446, 403, 1125, 823, 670, 803, 1284, 1253, 1254, 579, 289, 703, 705, 311, 776, 1104, 719, 480, 113, 609, 822, 1095, 1137, 1042, 1043, 1078, 519, 521, 520, 522, 523, 524, 525, 526, 858, 362, 375, 747, 272, 81, 661, 723, 821, 862, 140, 761, 63, 109, 1003, 1251, 1041, 1271, 998, 316, 317, 78, 978, 202, 1276, 824, 915, 711, 108, 185, 754, 928, 846, 847, 893, 1262, 1263, 769, 755, 906, 313, 314, 238, 239, 1034, 430, 299, 1247, 363, 40, 574, 486, 354, 710, 279, 280, 281, 845, 960, 306, 992, 989, 618, 225, 226, 173, 212, 8, 9, 157, 165, 344, 1147, 431, 590, 1083, 492, 28, 274, 753, 424, 425, 817, 820, 1237, 818, 819, 1207, 1301, 405, 974, 975, 976, 635, 924, 217, 381, 395, 111, 691, 815, 436, 437, 438, 35, 830, 938, 331, 1010, 1011, 79, 1267, 295, 65, 234, 1246, 796, 337, 1075, 270, 468, 376, 450, 451, 49, 505, 650, 1059, 1259, 1050, 465, 68, 636, 20, 383, 245, 246, 1261, 222, 374, 930, 793, 794, 795, 849, 712, 861, 1291, 325, 907, 908, 859, 605, 61, 544, 1289, 1285, 851, 1201, 921, 589, 1100, 273, 294, 800, 806, 333, 4, 118, 1195, 1197, 1135, 429, 264, 720, 707, 606, 43, 392, 418, 759, 1280, 179, 445, 215, 556, 1027, 21, 442, 791, 807, 76, 922, 1275, 427, 257, 266, 1268, 1336, 228, 460, 554, 194, 954, 956, 174, 1151, 684, 558, 559, 563, 564, 724, 1077, 702, 1092, 48, 779, 422, 583, 573, 413, 995, 541, 600, 183, 6, 1190, 699, 700, 701, 664, 876, 419, 666, 12, 243, 1017, 1037, 283, 1286, 30, 502, 790, 22, 778, 1117, 1239, 540, 169, 485, 26, 787, 507, 396, 382, 176, 986, 685, 682, 1141, 721, 91, 378, 773, 640, 641, 1021, 805, 304, 443, 562, 115, 259, 985, 159, 160, 994, 1186, 170, 82, 199, 271, 988, 481, 828, 860, 278, 219, 461, 549, 802, 66, 298, 552, 285, 497, 962, 534, 1073, 613, 1250, 1270, 1335, 611, 1122, 1124, 692, 766, 996, 997, 652, 900, 614, 517, 1172, 990, 991, 1176, 1310, 957, 780, 781, 1304, 686, 687, 688, 689, 1287, 1288, 1332, 1171, 634, 1198, 979, 1334, 843, 651, 678, 1317, 782, 987, 798, 825, 797, 1302, 1128, 604, 1321, 1322, 935, 838, 1218, 1225, 811, 1328, 762, 758, 1057, 1330, 763, 764, 765, 767, 953, 644, 1169, 1228, 421, 655, 662, 873, 874, 92, 1133, 1136, 632, 792, 218, 784, 760, 535, 542, 543, 895, 426, 1160, 117, 195, 255, 42, 839, 708, 536, 254, 1108, 41, 914, 359, 360, 408, 1019, 642, 90, 643, 286, 288, 290, 72, 74, 80, 1184, 955, 1063, 423, 706, 1252, 291, 483, 1007, 241, 625, 656, 751, 774, 630, 531, 939, 941, 1024, 478, 1143, 645, 646, 647, 648, 786, 660, 2, 840, 24, 674, 358, 1079, 110, 649, 102, 315, 1109, 1235, 38, 673, 1066, 925, 940, 934, 201, 1229, 121, 122, 1189, 902, 1116, 123, 34, 1206, 250, 64, 172, 369, 175, 1298, 1056, 490, 1013, 1014, 1026, 832, 578, 473, 138, 462, 841, 842, 1159, 808, 305, 530, 1074, 474, 475, 515, 620, 768, 857, 913, 103, 27, 603, 1158, 623, 968, 983, 1009, 993, 972, 1199, 1230, 1257, 267, 268, 1209, 293, 639, 1202, 182, 1040, 156, 158, 224, 163, 1157, 389, 1216, 510, 958, 1039, 1081, 444, 1192, 1238, 1045, 83, 491, 420, 1233, 969, 967, 952, 1023, 512, 569, 610, 1030, 551, 1012, 410, 1044, 330, 896, 1178, 251, 406, 404, 1004, 86, 397, 33, 748, 547, 1000, 399, 400, 366, 1018, 513, 345, 380, 94, 621, 95, 13, 428, 672, 1200, 977, 927, 1119, 1120, 1029, 190, 1208, 879, 901, 1224, 296, 297, 263, 342, 539, 726, 494, 1260, 319, 320, 586, 300, 276, 493, 624, 1111, 292, 368, 777, 84, 788, 789, 184, 338, 467, 107, 166, 1193, 898, 622, 1062, 1082, 1053, 200, 509, 532, 653, 1096, 695, 592, 884, 633, 327, 749, 394, 1215, 943, 971; (3) System Code: 722233; UDI: 00884838116764; System Serial Number: 64, 122, 169, 170, 267, 96, 144, 212, 153, 259, 118, 214, 41, 59, 124, 147, 103, 108, 111, 172, 127, 192, 218, 219, 250, 123, 37, 38, 183, 273, 304, 17, 137, 76, 300, 12, 201, 238, 82, 288, 295, 297, 298, 8, 141, 26, 27, 235, 68, 14, 138, 139, 117, 279, 58, 240, 28, 7, 280, 281, 31, 165, 166, 62, 100, 95, 29, 200, 203, 204, 205, 120, 310, 285, 292, 161, 181, 110, 112, 173, 160, 51, 75, 202, 86, 197, 176, 223, 211, 136, 227, 81, 16, 24, 184, 129, 156, 222, 253, 30, 284, 134, 143, 233, 162, 71, 40, 48, 101, 180, 105, 106, 133, 57, 61, 186, 189, 89, 90, 91, 145, 44, 231, 268, 312, 85, 221, 193, 194, 83, 84, 87, 88, 19, 5, 6, 18, 178, 60, 257, 55, 239, 243, 130, 234, 9, 32, 159, 217, 260, 56, 20, 225, 291, 50, 11, 72, 107, 35, 46, 47, 74, 43, 104, 78, 290, 272, 249, 77, 80, 174, 163, 97, 102, 146, 148, 149, 109, 15, 13, 39, 206, 67;
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527, 763000190446, 763000317591, 763000157043, 643169752726, 763000101527, 763000190446, 763000317591, 643169873841, 643169878648, 763000179632, 76300031759101, 76300031759103, 76300031762103, 763000367091, 763000317621, 763000157043, 76300031762101: MiniMed 630G System(M020092C004 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MiniMed 630G Insulin pump MODEL MMT-1714(M993428A262 1); MiniMed 630G System User Guide(M020092C001 3, M020092C003 1, M020092C005 1); MINIMED 630G SYSTEM USER GUIDE mg/dL(M979512A011 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(MP6026120-262 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(M030278C001 3, M030278C002 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE mmol/L (MP6026120-024 1); MiniMed Veo with Enlite Threshold Suspend Performance(M10577668A262 1).
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 640G Insulin Pump: 643169999763, 763000002763, 763000002671, 643169999770, 763000002886, 643169729353, 763000002657, 763000002688, 763000002664, 763000002749, 763000002817, 763000002787, 763000002800, 763000002756, 763000002848, 763000002794, 763000002695, 763000002725, 763000002701, 763000002633, 763000002862, 643169729360, 763000002879, 763000002824, 763000002732, 763000002640, 763000002770, 763000002855, 763000002718, 763000002831, 763000065195, 763000065201, 763000083441, 763000015510, 763000015541, 763000015480, 763000015589, 763000015497, 763000068998, 763000015381, 763000015435, 763000015336, 763000015367, 763000069001, 763000015374, 763000015398, 763000015350, 763000192228, 763000015572, 763000015343, 763000015411, 763000015428, 763000015404, 763000015442, 763000015459, 763000015534, 763000015503, 763000194383, 763000194222, 763000194444, 763000194390, 763000194239, 763000198596, 763000194406, 763000194369, 763000015596, 763000194277, 763000194666, 763000194352, 763000198602, 763000192211, 763000194451, 763000015565, 763000194246, 763000194338, 763000194307, 763000194475, 763000194314, 763000155346, 763000194468, 763000194437, 763000194376, 763000194345, 763000194253, 763000194260, 763000194413, 763000194420, 763000192136, 763000192143, 763000165246, 763000165307, 763000165130, 643169629813, 763000194321, 763000194291, 763000165147, 763000165277, 763000165222, 763000165116, 763000165123, 763000165185, 763000165154, 763000165314, 763000165338, 763000165260, 763000165093, 763000165284, 763000165215, 763000165109, 763000165345, 763000258337, 763000258344, 763000317140, 763000319274, 763000319540, 763000319618, 763000317089, 763000319489, 763000319533, 763000319380, 763000319366, 763000319267, 763000319298, 763000319304, 763000319236, 763000319328, 763000319571, 763000319229, 763000319281, 763000319311, 763000319588, 763000319519, 763000319243, 763000347536, 763000319427, 763000404567, 763000319557, 763000319564, 763000319410, 763000319526, 763000319434, 763000319595, 763000319373, 763000319397, 763000402686, 763000319441, 763000319359, 763000319496, 763000319458, 763000404550, 763000402693, 763000317188, 763000317102, 763000317119, 763000319342, 763000402709, 763000317195, 763000367039, 763000367046, 763000317157, 643169554931, 643169554948, 643169554917, 643169629691, 643169554955, 643169629677, 643169629653, 643169629684, 643169554924, 643169629660, 643169596429, 643169521049, 643169596405, 643169521315, 643169522138, 643169577664, 643169577688, 643169577695, 643169596368, 643169596382, 643169521865, 643169596443, 643169520882, 643169662544, 643169672239, 643169672246, 643169672260, 643169672277, 643169672253, 643169662582, 643169682672, 643169662551, 643169662568, 643169681972, 643169662575, 643169683211, 643169682405, 643169682139, 643169682788, 643169682245, 643169739468, 643169739451, 643169739482, 643169739444, 643169739512, 643169739475, 643169682948, 643169999800, 643169721289, 643169668874, 643169999787, 763000115968, 763000013066, 763000074814, 763000074821, 763000192204, 763000192198, 763000253288, 763000324704, 763000324698, 763000324681, 00763000115968: MINIMED 640G SYSTEM USER GUIDE(MP6025958-116 1, MP6025958-393 1, M052248C002 1, M052249C002 1).
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 780G Insulin Pump: 763000411541, 763000441449, 763000523305, 763000521530, 763000521516, 763000533861, 763000544317, 763000734459, 763000758530, 763000758547, 763000578688, 763000734435, 763000504762, 763000734466, 763000924102, 763000924089, 763000454296, 763000854829, 763000411411, 763000411503, 763000384272, 763000411466, 763000411428, 763000411572, 763000411589, 763000411558, 763000384265, 763000411473, 763000411374, 763000411435, 763000411404, 763000384289, 763000411459, 763000411510, 763000411626, 763000411565, 763000411527, 763000411619, 763000411596, 763000411497, 763000411398, 763000411534, 763000411381, 763000384258, 763000411480, 763000411602, 763000411640, 763000411442, 763000441432, 763000442194, 763000521523, 763000442187, 763000521509, 763000521547, 763000578671, 763000596194, 763000639228, 763000639235, 763000639266, 763000974381, 763000974374, 763000921750, 763000921767, 763000921590, 763000921637, 763000933593, 763000891886, 763000921729, 763000921866, 763000921781, 763000921811, 763000921576, 763000921583, 763000921620, 763000921859, 763000891909, 763000921743, 763000944162, 763000921712, 763000921668, 763000933579, 763000933555, 763000933586, 763000933609, 763000921613, 763000933715, 763000933548, 763000944209, 763000891893, 763000933623, 763000933722, 763000933814, 763000933708, 763000933777, 763000933685, 763000933531, 763000933678, 763000933821, 763000933746, 763000933562, 763000944193, 763000533878, 763000734442, 763000854942, 763000914127: Medtronic MiniMed 780G with Instinct sensor System User Guide(M018856C024 2, M018857C035 2); Medtronic MiniMed 780G with Simplera Sync sensor System User Guide(M018857C034 2); Medtronic MiniMed 780G with Guardian 4 Sensor System User Guide(M028790C004 2, M028792C004 2); Medtronic MiniMed 780G with Guardian 4 Sensor System User Guide(M028792C015 1, M028792C001 3, M028792C002 1, M028792C006 1, M028792C003 1, M028792C005 1); Medtronic MiniMed 780G with Instinct sensor System User Guide(M018857C008 1, M018857C011 1, M018857C029 1, M018856C022 1, M018857C013 1, M018856C007 1, M018857C001 4, M018856C001 4, M018856C010 1, M018857C012 1, M018856C020 1, M018857C009 1, M018857C032 1, M018857C022 1, M018856C021 1, M018856C013 1, M018857C028 1, M018857C033 1, M018856C017 1, M018857C016 1, M018856C018 1); Medtronic MiniMed 780G with Simplera Sync sensor System User Guide(M018856C023 2, M018857C034 2); MiniMed 780G System Technical Guide(M075489C003 1, M075489C002 1, M075489C001 2); MiniMed 780G System User Guide(M072481C001 2); MiniMed 780G with Guardian 4 Sensor System User Guide mg(, M073070C003 1, M073070C001 2, M073070C002 1); MiniMed 780G with Guardian 4 Sensor System User Guide mm(M076019C002 1, M076019C001 1); MiniMed 780G with Guardian 4 Sensor System User Guide(M028790C003 1, M028790C002 1); MiniMed 780G system Changing the Medtronic Extended Infusion Set with Extended Reservoir(M048911C001 2, M048911C003 1, M048911C002 1); MiniMed 780G system Changing the MiniMed Mio Advance Infusion Set and Reservoir(M047607C001 1); MiniMed 780G system Changing the MiniMed Silhouette Infusion Set and Reservoir(M047610C001 1, M047610C003 1, M047610C002 1); MiniMed 780G system Changing the MiniMed Sure-T Infusion Set and Reservoir(M047609C001 1, M047609C003 1, M047607C003 1, M047607C002 1, M047609C002 1); MiniMed 780G System User Guide(M024832C003 2, M024829C004 2, M024832C004 2, M024829C005 2); MiniMed 780G System User Guide mg/dl(M014786C005 2, M014784C005 2, M014786C007 1, M014784C007 1, M014784C004 1, M014786C004 1, M014786C008 1, M014784C008 1, M014784C002 1, M014786C006 1, M014784C006 1, M014784C016 1, M014786C016 1, M014784C012 1, M014786C012 1, M014786C002 1, M014784C010 1, M014786C010 1, M014784C003 1, M014786C003 1, M014784C011 1, M014786C011 1, M014786C013 1, M014784C013 1, M014784C015 1, M014786C015 1, M014786C019 1, M014784C019 1); MiniMed 780G System User Guide mmol/L(M014787C002 1, M014785C002 1, M014785C007 2, M014787C007 1, M014787C005 1, M014785C005 1, M014787C006 1, M014785C006 1, M014785C023 2, M014787C023 2, M014787C010 1, M014785C010 1, M014787C011 1, M014785C011 1, M014787C021 1, M014785C021 1, M014787C008 1, M014785C008 1, M014785C009 1, M014787C009 1, M014787C022 1, M014785C022 1, M014785C027 1, M014787C027 1, M014787C004 2, M014785C004 2, M014785C003 1, M014787C003 1, M014785C030 1, M014787C030 1, M014785C013 2, M014787C013 2, M014785C019 1, M014787C019 1, M014785C020 1, M014787C020 1, M014787C018 1, M014785C018 1, M014787C012 1, M014785C012 1, M014787C016 1, M014785C016 1, M014787C024 1, M014785C024 1, M014785C014 2, M014787C014 1, M014787C028 1, M014785C028 1); MiniMed 780G with Guardian 4 Sensor System User Guide(M060264C012 1, M060263C011 1, M060264C018 1, M060263C015 1, M060264C017 1, M060263C014 1, M060264C006 1, M060264C004 1, M060263C001 3, M060263C016 1, M060264C007 1, M060264C008 1, M060264C009 1, M060264C010 1, M060264C011 1, M060264C001 3, M060264C013 1, M060264C014 1, M060264C023 1, M028790C005 1, M060263C020 1, M060264C015 1, M060264C016 1, M060264C020 1, M060263C021 1, M028790C006 1, M060263C022 1, M056377C001 3, M056377C003 1, M056377C002 1, M060263C023 1, M060264C021 1, M060264C022 1, M060263C024 1); MiniMed 780G with Guardian 4 Sensor System User Guide mg/dl(M028790C001 3, M028790C011 1, M028790C007 1, M028790C008 1, M028790C010 1, M028790C019 1); MiniMed 780G with Guardian 4 Sensor System User Guide mmol/L(M028792C012 1, M028792C013 1, M028792C007 1, M028792C011 1, M028792C025 1, M028792C014 1, M028792C001 3, M028792C033 1, M028792C010 1); MiniMed 780G with Instinct sensor System User Guide(M018857C004 1); MiniMed 780G with Simplera Sync sensor System User Guide(M060262C008 1, M060261C002 1, M018857C003 1, M018856C003 1, M060262C015 1, M018856C005 1, M060261C004 1, M060261C003 1, M018856C006 1, M060262C014 1, M060262C002 1, M060261C001 3, M060261C005 1, M060262C003 1, M060262C004 1, M060262C005 1, M060262C006 1, M060262C007 1, M060262C001 3, M060262C009 1, M018857C015 1, M060262C010 1, M018856C009 1, M060261C009 1, M060262C021 1, M018857C034 2, M060262C012 1, M060262C013 1, M060262C016 1, M018856C012 1, M060261C010 1, M060261C011 1, M056047C001 3, M056047C003 1, M056047C002 1, M060261C012 1, M060262C019 1, M060262C020 1, M060261C013 1); MiniMed 780G with the Guardian 4 Sensor System User Guide(M036461C004 2, M036461C001 2, M036461C007 1, M036461C003 1, M036461C002 1, M036461C006 1); MiniMed 780G with the Guardian Sensor (3) System User Guide(M010682C005 2, M010682C008 1); MiniMed 780G with the Guardian Sensor 3 System User Guide(M010682C002 2, M010682C004 1, M010682C007 1, M010682C003 1)
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Frontal Aprons
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8F17; UDI-DI (Product Code): 00840331297706 (FRONTALC18-C8F17-2XM ), 00840331297706 (FRONTALC8-C8F17-LF ), 00840331297706 (FRONTALC8-C8F17-LM ), 00840331297706 (FRONTALC8-C8F17-MF ), 00840331297706 (FRONTALC8-C8F17-MM ), 00840331297706 (FRONTALC8-C8F17-SF ), 00840331297706 (FRONTALC8-C8F17-SM ), 00840331297706 (FRONTALC8-C8F17-XLM ), 00840331297706 (FRONTALC8-C8F17-XSF ), 00840331297706 (FRONTALT18-C8F17-LM ), 00840331297706 (FRONTALT18-C8F17-MM ), 00840331297706 (FRONTALT28-C8F17-3XM ). 2. Model Number: R8601; UDI-DI (Product Code): 00840331258400 (FRONTALC18-R8601-2XF ), 00840331258417 (FRONTALC18-R8601-2XM ), 00840331258448 (FRONTALC8-R8601-LF ), 00840331258455 (FRONTALC8-R8601-LM ), 00840331258462 (FRONTALC8-R8601-MF ), 00840331258479 (FRONTALC8-R8601-MM ), 00840331258486 (FRONTALC8-R8601-PLUS ), 00840331258493 (FRONTALC8-R8601-SF ), 00840331258509 (FRONTALC8-R8601-SM ), 00840331258516 (FRONTALC8-R8601-XLF ), 00840331258523 (FRONTALC8-R8601-XLM ), 00840331270341 (FRONTALT18-R8601-LF ), 00840331270358 (FRONTALT18-R8601-LM ), 00840331270341 (FRONTALT18-R8601-MF ), 00840331270358 (FRONTALT18-R8601-MM ), 00840331270341 (FRONTALT18-R8601-PLUS ), 00840331270341 (FRONTALT18-R8601-SF ), 00840331270358 (FRONTALT18-R8601-SM ), 00840331270358 (FRONTALT18-R8601-XLM ), 00840331270341 (FRONTALT28-R8601-2XF ), 00840331270358 (FRONTALT28-R8601-2XM ), 00840331270358 (FRONTALT28-R8601-3XM ), 00840331270358 (FRONTALT28-R8601-4XM ), None (IFRONTALC8-R8601-2XMR ), None (IFRONTALC8-R8601-LMR ), None (IFRONTALC8-R8601-MFR ), None (IFRONTALC8-R8601-MMR ), None (IFRONTALC8-R8601-SFR ), None (IFRONTALC8-R8601-SMR ), None (IFRONTALC8-R8601-XLMR ), None (IFRONTALC8-R8601-XSFR ), None (IFRONTALC8-R8601-XSMR ), None (IFRONTALC8-R8601-LML ). 3. Model Number: R8A10; UDI-DI (Product Code): 00840331258578 (FRONTALC18-R8A10-2XM ), 00840331258608 (FRONTALC8-R8A10-LF ), 00840331258615 (FRONTALC8-R8A10-LM ), 00840331258622 (FRONTALC8-R8A10-MF ), 00840331258639 (FRONTALC8-R8A10-MM ), 00840331258646 (FRONTALC8-R8A10-PLUS ), 00840331258653 (FRONTALC8-R8A10-SF ), 00840331258660 (FRONTALC8-R8A10-SM ), 00840331258677 (FRONTALC8-R8A10-XLF ), 00840331258684 (FRONTALC8-R8A10-XLM ), 00840331258691 (FRONTALC8-R8A10-XSF ), 00840331258707 (FRONTALC8-R8A10-XSM ), 00840331270280 (FRONTALT18-R8A10-LF ), 00840331270297 (FRONTALT18-R8A10-LM ), 00840331270280 (FRONTALT18-R8A10-MF ), 00840331270297 (FRONTALT18-R8A10-MM ), 00840331270280 (FRONTALT18-R8A10-PLUS ), 00840331270280 (FRONTALT18-R8A10-SF ), 00840331270297 (FRONTALT18-R8A10-SM ), 00840331270297 (FRONTALT18-R8A10-XLM ), 00840331270297 (FRONTALT28-R8A10-2XM ), 00840331270297 (FRONTALT28-R8A10-3XM ), 00840331270297 (FRONTALT28-R8A10-4XM ), 00840331270297 (FRONTALT28-R8A10-5XM ), None (IFRONTALC8-R8A10-LMR ), None (IFRONTALC8-R8A10-MFR ), None (IFRONTALC8-R8A10-MMR ), None (IFRONTALC8-R8A10-XLMR ). 4. Model Number: R8F01; UDI-DI (Product Code): 00840331258899 (FRONTALC18-R8F01-2XM ), 00840331258929 (FRONTALC8-R8F01-LF ), 00840331258936 (FRONTALC8-R8F01-LM ), 00840331258943 (FRONTALC8-R8F01-MF ), 00840331258950 (FRONTALC8-R8F01-MM ), 00840331258936 (FRONTALS8-R8F01-LM ), 00840331258943 (FRONTALS8-R8F01-MF ), 00840331259001 (FRONTALS8-R8F01-XLM ). 5. Model Number: R8F17; UDI-DI (Product Code): 00840331259360 (FRONTALC18-R8F17-2XF ), 00840331259377 (FRONTALC18-R8F17-2XM ), 00840331259384 (FRONTALC18-R8F17-3XF ), 00840331259391 (FRONTALC18-R8F17-3XM ), 00840331259407 (FRONTALC8-R8F17-LF ), 00840331259414 (FRONTALC8-R8F17-LM ), 00840331259421 (FRONTALC8-R8F17-MF ), 00840331259438 (FRONTALC8-R8F17-MM ), 00840331259445 (FRONTALC8-R8F17-PLUS ), 00840331259452 (FRONTALC8-R8F17-SF ), 00840331259469 (FRONTALC8-R8F17-SM ), 00840331259476 (FRONTALC8-R8F17-XLF ), 00840331259483 (FRONTALC8-R8F17-XLM ), 00840331259490 (FRONTALC8-R8F17-XSF ), 00840331259506 (FRONTALC8-R8F17-XSM ), 00840331259407 (FRONTALS8-R8F17-LF ), 00840331259414 (FRONTALS8-R8F17-LM ), 00840331259414 (FRONTALS8-R8F17-MF ), 00840331259438 (FRONTALS8-R8F17-MM ), 00840331259452 (FRONTALS8-R8F17-SF ), 00840331259469 (FRONTALS8-R8F17-SM ), 00840331259476 (FRONTALS8-R8F17-XLF ), 00840331259483 (FRONTALS8-R8F17-XLM ), 00840331259506 (FRONTALS8-R8F17-XSM ), 00840331270228 (FRONTALT18-R8F17-LF ), 00840331270235 (FRONTALT18-R8F17-LM ), 00840331270228 (FRONTALT18-R8F17-MF ), 00840331270235 (FRONTALT18-R8F17-MM ), 00840331270228 (FRONTALT18-R8F17-PLUS ), 00840331270228 (FRONTALT18-R8F17-SF ), 00840331270235 (FRONTALT18-R8F17-SM ), 00840331270228 (FRONTALT18-R8F17-XLF ), 00840331270235 (FRONTALT18-R8F17-XLM ), 00840331270228 (FRONTALT18-R8F17-XSF ), 00840331270235 (FRONTALT18-R8F17-XSM ), 00840331270228 (FRONTALT28-R8F17-2XF ), 00840331270235 (FRONTALT28-R8F17-2XM ), 00840331270228 (FRONTALT28-R8F17-3XF ), 00840331270235 (FRONTALT28-R8F17-3XM ), 00840331270228 (FRONTALT28-R8F17-4XF ), 00840331270235 (FRONTALT28-R8F17-4XM ), 00840331270228 (FRONTALT28-R8F17-5XF ), None (IFRONTALC8-R8F17-LML ), None (IFRONTALC8-R8F17-MMR ), None (IFRONTALC8-R8F17-XLMXL ), None (IFRONTALC8-R8F17-MFR ), None (IFRONTALC8-R8F17-MML ), None (IFRONTALC8-R8F17-SMR ), None (IFRONTALC8-R8F17-PLUSL ), None (IFRONTALC8-R8F17-SFR ), None (IFRONTALC8-R8F17-LFR ), None (IFRONTALC8-R8F17-MFS ), None (IFRONTALC8-R8F17-SML ), None (IFRONTALC8-R8F17-LMR ). 6. Model Number: R8P500; UDI-DI (Product Code): 00197513001287 (PFRONTALC8-R8P500-LG ), 00197513001270 (PFRONTALC8-R8P500-MD ). 7. Model Number: S8601; UDI-DI (Product Code): 00840331262179 (FRONTALC18-S8601-2XM ), 00840331262209 (FRONTALC8-S8601-LF ), 00840331296174 (FRONTALC8-S8601-LM ), 00840331262216 (FRONTALC8-S8601-MF ), 00840331262223 (FRONTALC8-S8601-MM ), 00840331262230 (FRONTALC8-S8601-PLUS ), 00840331262247 (FRONTALC8-S8601-SF ), 00840331262254 (FRONTALC8-S8601-SM ), 00840331262261 (FRONTALC8-S8601-XLF ), 00840331262278 (FRONTALC8-S8601-XLM ), 00840331262285 (FRONTALC8-S8601-XSF ), 00840331270365 (FRONTALT18-S8601-LF ), 00840331270372 (FRONTALT18-S8601-LM ), 00840331270365 (FRONTALT18-S8601-MF ), 00840331270372 (FRONTALT18-S8601-MM ), 00840331270365 (FRONTALT18-S8601-PLUS ), 00840331270372 (FRONTALT18-S8601-SM ), 00840331270372 (FRONTALT18-S8601-XLF ), 00840331270372 (FRONTALT18-S8601-XLM ), 00840331270372 (FRONTALT28-S8601-2XM ), 00840331270372 (FRONTALT28-S8601-3XM ), 00840331270372 (FRONTALT28-S8601-4XM ), None (IFRONTALC8-S8601-PLUSL ). 8. Model Number: S8A10; UDI-DI (Product Code): 00840331262315 (FRONTALC18-S8A10-2XF ), 00840331262322 (FRONTALC18-S8A10-2XM ), 00840331262339 (FRONTALC18-S8A10-3XF ), 00840331262353 (FRONTALC8-S8A10-LF ), 00840331262360 (FRONTALC8-S8A10-LM ), 00840331262377 (FRONTALC8-S8A10-MF ), 00840331262384 (FRONTALC8-S8A10-MM ), 00840331262391 (FRONTALC8-S8A10-PLUS ), 00840331262407 (FRONTALC8-S8A10-SF ), 00840331262414 (FRONTALC8-S8A10-SM ), 00840331262421 (FRONTALC8-S8A10-XLF ), 00840331262438 (FRONTALC8-S8A10-XLM ), 00840331262445 (FRONTALC8-S8A10-XSF ), 00840331270303 (FRONTALT18-S8A10-LF ), 00840331270310 (FRONTALT18-S8A10-LM ), 00840331270303 (FRONTALT18-S8A10-MF ), 00840331270310 (FRONTALT18-S8A10-MM ), 00840331270303 (FRONTALT18-S8A10-PLUS ), 00840331270303 (FRONTALT18-S8A10-SF ), 00840331270310 (FRONTALT18-S8A10-SM ), 00840331270303 (FRONTALT18-S8A10-XLF ), 00840331270310 (FRONTALT18-S8A10-XLM ), 00840331270310 (FRONTALT28-S8A10-2XM ), 00840331270303 (FRONTALT28-S8A10-3XF ), 00840331270310 (FRONTALT28-S8A10-4XM ), 00840331270303 (FRONTALT28-S8A10-5XF ). 9. Model Number: S8F01; UDI-DI (Product Code): 00840331262674 (FRONTALC8-S8F01-LF ), 00840331262698 (FRONTALC8-S8F01-MF ), 00840331262704 (FRONTALC8-S8F01-MM ), 00840331262728 (FRONTALC8-S8F01-SF ), 00840331262742 (FRONTALC8-S8F01-XLF ), 00840331262759 (FRONTALC8-S8F01-XLM ), 00840331262766 (FRONTALC8-S8F01-XSF ), 00840331270433 (FRONTALT18-S8F01-MM ), 00840331270426 (FRONTALT18-S8F01-PLUS ). 10. Model Number: S8F17; UDI-DI (Product Code): 00840331263114 (FRONTALC18-S8F17-2XF ), 00840331263121 (FRONTALC18-S8F17-2XM ), 00840331263138 (FRONTALC18-S8F17-3XF ), 00840331263145 (FRONTALC18-S8F17-3XM ), 00840331263152 (FRONTALC8-S8F17-LF ), 00840331263169 (FRONTALC8-S8F17-LM ), 00840331263176 (FRONTALC8-S8F17-MF ), 00840331263183 (FRONTALC8-S8F17-MM ), 00840331263190 (FRONTALC8-S8F17-PLUS ), 00840331263206 (FRONTALC8-S8F17-SF ), 00840331263213 (FRONTALC8-S8F17-SM ), 00840331263220 (FRONTALC8-S8F17-XLF ), 00840331263237 (FRONTALC8-S8F17-XLM ), 00840331263244 (FRONTALC8-S8F17-XSF ), 00840331263251 (FRONTALC8-S8F17-XSM ), 00840331263152 (FRONTALS8-S8F17-LF ), 00840331263169 (FRONTALS8-S8F17-LM ), 00840331263176 (FRONTALS8-S8F17-MF ), 00840331263183 (FRONTALS8-S8F17-MM ), 00840331263190 (FRONTALS8-S8F17-PLUS ), 00840331263206 (FRONTALS8-S8F17-SF ), 00840331263213 (FRONTALS8-S8F17-SM ), 00840331263220 (FRONTALS8-S8F17-XLF ), 00840331263237 (FRONTALS8-S8F17-XLM ), 00840331263244 (FRONTALS8-S8F17-XSF ), 00840331263251 (FRONTALS8-S8F17-XSM ), 00840331270242 (FRONTALT18-S8F17-LF ), 00840331270259 (FRONTALT18-S8F17-LM ), 00840331270242 (FRONTALT18-S8F17-MF ), 00840331270259 (FRONTALT18-S8F17-MM ), 00840331270242 (FRONTALT18-S8F17-PLUS ), 00840331270242 (FRONTALT18-S8F17-SF ), 00840331270259 (FRONTALT18-S8F17-SM ), 00840331270242 (FRONTALT18-S8F17-XLF ), 00840331270259 (FRONTALT18-S8F17-XLM ), 00840331270242 (FRONTALT18-S8F17-XSF ), 00840331270259 (FRONTALT18-S8F17-XSM ), 00840331270242 (FRONTALT28-S8F17-2XF ), 00840331270259 (FRONTALT28-S8F17-2XM ), 00840331270242 (FRONTALT28-S8F17-3XF ), 00840331270259 (FRONTALT28-S8F17-3XM ), 00840331270242 (FRONTALT28-S8F17-4XF ), 00840331270259 (FRONTALT28-S8F17-4XM ), 00840331270242 (FRONTALT28-S8F17-5XF ), 00840331270259 (FRONTALT28-S8F17-5XM ). 11. Model Number: U8601; UDI-DI (Product Code): 00840331265927 (FRONTALC8-U8601-LF ), 00840331265934 (FRONTALC8-U8601-LM ), 00840331265941 (FRONTALC8-U8601-MF ), 00840331265958 (FRONTALC8-U8601-MM ), 00840331265972 (FRONTALC8-U8601-SF ), 00840331265989 (FRONTALC8-U8601-SM ), 00840331265996 (FRONTALC8-U8601-XLF ), 00840331266009 (FRONTALC8-U8601-XLM ), 00840331266023 (FRONTALC8-U8601-XSM ), 00840331270389 (FRONTALT18-U8601-LF ), 00840331270396 (FRONTALT18-U8601-LM ), 00840331270389 (FRONTALT18-U8601-MF ), 00840331270396 (FRONTALT18-U8601-MM ), 00840331270389 (FRONTALT18-U8601-PLUS ), 00840331270389 (FRONTALT18-U8601-XLF ), 00840331270396 (FRONTALT18-U8601-XLM ), 00840331270396 (FRONTALT28-U8601-2XM ), None (IFRONTALC8-U8601-LML ). 12. Model Number: U8A10; UDI-DI (Product Code): 00840331266054 (FRONTALC18-U8A10-2XM ), 00840331266085 (FRONTALC8-U8A10-LF ), 00840331266092 (FRONTALC8-U8A10-LM ), 00840331266108 (FRONTALC8-U8A10-MF ), 00840331266115 (FRONTALC8-U8A10-MM ), 00840331266122 (FRONTALC8-U8A10-PLUS ), 00840331266139 (FRONTALC8-U8A10-SF ), 00840331266146 (FRONTALC8-U8A10-SM ), 00840331266160 (FRONTALC8-U8A10-XLM ), 00840331270327 (FRONTALT18-U8A10-LF ), 00840331270334 (FRONTALT18-U8A10-LM ), 00840331270334 (FRONTALT18-U8A10-MM ), 00840331270334 (FRONTALT18-U8A10-PLUS ), 00840331270334 (FRONTALT18-U8A10-XLM ), 00840331270327 (FRONTALT28-U8A10-2XF ). 13. Model Number: U8F01; UDI-DI (Product Code): 00840331266450 (FRONTALC8-U8F01-SF ), 14. Model Number: U8F17; UDI-DI (Product Code): 00840331266856 (FRONTALC18-U8F17-2XM ), 00840331266863 (FRONTALC18-U8F17-3XF ), 00840331266870 (FRONTALC18-U8F17-3XM ), 00840331266887 (FRONTALC8-U8F17-LF ), 00840331266894 (FRONTALC8-U8F17-LM ), 00840331266900 (FRONTALC8-U8F17-MF ), 00840331266917 (FRONTALC8-U8F17-MM ), 00840331266924 (FRONTALC8-U8F17-PLUS ), 00840331266931 (FRONTALC8-U8F17-SF ), 00840331266948 (FRONTALC8-U8F17-SM ), 00840331266955 (FRONTALC8-U8F17-XLF ), 00840331266962 (FRONTALC8-U8F17-XLM ), 00840331266979 (FRONTALC8-U8F17-XSF ), 00840331266979 (FRONTALC8-U8F17-XSM ), 00840331266894 (FRONTALS8-U8F17-LM ), 00840331266900 (FRONTALS8-U8F17-MF ), 00840331266917 (FRONTALS8-U8F17-MM ), 00840331266931 (FRONTALS8-U8F17-SF ), 00840331266948 (FRONTALS8-U8F17-SM ), 00840331266962 (FRONTALS8-U8F17-XLM ), 00840331266986 (FRONTALS8-U8F17-XSM ), 00840331270266 (FRONTALT18-U8F17-LF ), 00840331270273 (FRONTALT18-U8F17-LM ), 00840331270266 (FRONTALT18-U8F17-MF ), 00840331270273 (FRONTALT18-U8F17-MM ), 00840331270266 (FRONTALT18-U8F17-PLUS ), 00840331270266 (FRONTALT18-U8F17-SF ), 00840331270273 (FRONTALT18-U8F17-SM ), 00840331270266 (FRONTALT18-U8F17-XLF ), 00840331270273 (FRONTALT18-U8F17-XLM ), 00840331270273 (FRONTALT18-U8F17-XSM ), 00840331270266 (FRONTALT28-U8F17-2XF ), 00840331270273 (FRONTALT28-U8F17-2XM ), 00840331270266 (FRONTALT28-U8F17-3XF ), 00840331270273 (FRONTALT28-U8F17-3XM ), 00840331270266 (FRONTALT28-U8F17-4XF ), 00840331270273 (FRONTALT28-U8F17-4XM ), None (IFRONTALC8-U8F17-2XMR ), None (IFRONTALC8-U8F17-LMR ), None (IFRONTALC8-U8F17-MMR ).
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 530G: 00643169507784, 00643169736061, 00643169736092, 00643169736085, 00643169933224, 00763000161170: Artwork, CRB A Process, Instr, 530G, One Press, Launch, US(MP6026081-012DOC); Artwork, CRB A Process, Instr, 530G, FDA comments, add TST(MP6025813-013DOC); Artwork, CRB A Process, Instr, 530G, Remove Velcro, Icons, US(MP6025813-014DOC);
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B 7. LEX THORACIC, DYNJ902016K DYNJ902016L 8. ORGAN PROCUREMENT, DYNJ908686 9. PULMONARY PACK, DYKE1859 10. THORACIC, DYNJ901666L 11. THORACIC ROBOTICS, DYNJ908777A 12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O 13. XPS, DYNJ907605
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
1. DYKE2091 UDI-DI 10198459606397 (EA) 40198459606398 (CS) LOT 25LBR616 2. DYNJ900898G UDI-DI 10195327479473 (EA) 40195327479474 (CS) LOTS 23JBI824 23KBJ535 24ABR789 24ABV917 24BBU610 24DMK530 24FMF039 24GME122 24JMB670 24KMH657 25AMA403 25BME938 DYNJ901922I UDI-DI 10198459237270 (EA) 40198459237271 (CS) LOTS 25BBL628 25FBM655 25HBW072 25KBO230 3. DYNJ38313B UDI-DI 10884389857700 (EA) 40884389857701 (CS) LOTS 24BBR676 24CBF032 24FBD924 24JBE567 25EBA277 25FBO580 25IBI418 4. DYNJ32750G UDI-DI 10889942212491 (EA) 40889942212492 (CS) LOTS 23KME954 23LMD492 24BMF722 24FMH267 24HMC509 DYNJ32750I UDI-DI 10198459245695 (EA) 40198459245696 (CS) LOTS 25BMA765 25DMC474 25EMI991 25IME718 26AMJ190 5. DYNJ911252 UDI-DI 10198459305030 (EA) 40198459305031 (CS) LOTS 25EBU007 25LBC286 25LBI365 26ABC803 26ABU372 6. DYNJ58146B UDI-DI 10198459478253 (EA) 40198459478254 (CS) LOTS 25HMG837 25JMJ636 26AMJ160 7. DYNJ902016K UDI-DI 10195327391706 (EA) 40195327391707 (CS) LOTS 23JBL313 23KBX206 24ABG361 24ABS317 24CBU624 24DBT777 24EBP517 24IBB815 24LBH029 24LBK316 25BBD830 25BBK993 25DBQ241 25DBR926 DYNJ902016L UDI-DI 10198459452703 (EA) 40198459452704 (CS) LOTS 25HBV912 25IBT298 25KBT137 8. DYNJ908686 UDI-DI 10195327145330 (EA) 40195327145331 (CS) LOT 23LBG479 9. DYKE1859 UDI-DI 10195327171469 (EA) 40195327171460 (CS) LOTS 23LBU165 24ABT730 24CBL345 24FBK106 24HBJ512 25DBS024 25EBL346 10. DYNJ901666L UDI-DI 10193489986815 (EA) 40193489986816 (CS) LOTS 24DDC241 24EDB399 11. DYNJ908777A UDI-DI 10195327415174 (EA) 40195327415175 (CS) LOTS 23JBV709 23KBC057 23LBP026 23LBP071 23LBP286 24BBH036 24DBD851 24FBC615 24GBH920 24HBS270 24KBL822 25ABE547 25BBP040 25BBR359 25CBA577 12. DYNJ900482N UDI-DI 10195327509941 (EA) 40195327509942 (CS) LOTS 23KDB600 24ADA178 DYNJ900482O UDI-DI 10195327596569 (EA) 40195327596560 (CS) LOTS 24CDA456 24EDC051 24GDB830 24IDB049 24JDB140 24KDA731 25ADB869 25BDA267 25CMD906 13. DYNJ907605 UDI-DI 10193489468052 (EA) 40193489468053 (CS) LOTS 23JBA743 23JBI519 23LBQ647 24ABX014 24BBQ594
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722064; UDI: 00884838085282; System Serial Number: 209, 238, 201, 258, 260, 261, 314, 229, 291, 270, 267, 218, 335, 513, 61, 161, 162, 169, 297, 131, 479, 190, 268, 173, 220, 256, 290, 502, 425, 412, 89, 303, 130, 157, 60, 263, 264, 253, 254, 257, 280, 373, 417, 9, 277, 102, 467, 461, 137, 46, 101, 84, 510, 5, 78, 49, 345, 180, 185, 266, 271, 193, 212, 213, 214, 431, 250, 186, 246, 282, 354, 374, 274, 127, 451, 106, 490, 329, 276, 58, 81, 200, 179, 249, 156, 184, 6, 448, 10, 82, 323, 35, 69, 278, 511, 39, 40, 45, 66, 125, 484, 36, 94, 497, 104, 422, 132, 67, 183, 439, 70, 446, 50, 138, 292, 293, 321, 379, 151, 237, 519, 520, 208, 462, 342, 57, 222, 391, 98, 441, 320, 494, 79, 65, 87, 109, 75, 311, 442, 485, 121, 68, 384, 228, 252, 91, 73, 74, 124, 191, 122, 421, 119, 309, 400, 251, 468, 480, 387, 269, 111, 11, 147, 509, 454, 478, 262, 491, 133, 337, 275, 414, 405, 396, 247, 310, 406, 517, 432, 457, 426, 304, 469, 340, 393, 343, 458, 322, 444, 508, 445, 395, 385, 505, 472, 514, 333, 236, 471, 234, 503, 394, 407, 470, 498, 504, 413, 7, 440, 463, 330, 475, 473, 501, 308, 225, 483, 474, 344, 389, 492, 324, 265, 235, 120, 496, 427, 341, 287, 288, 289, 380, 149, 150, 176, 197, 230, 231, 233, 44, 100, 51, 388, 118, 62, 123, 177, 47, 272, 110, 59, 167, 174, 165, 401, 452, 41, 168, 447, 148, 182, 112, 302, 86, 317, 198, 378, 206, 136, 312, 143, 403, 386, 397, 500, 226, 408, 43, 381, 488, 443, 416, 80, 12, 404, 285, 515, 476, 449, 477, 338, 419, 215, 164, 434, 114, 144, 327, 227, 295, 294, 319, 241, 126, 92, 284, 175, 199, 372, 188, 429, 296, 172, 283, 357, 306, 437, 210, 315, 134, 255, 207, 192, 116, 221, 189, 117, 313, 187, 166, 96, 135, 108, 37, 245, 72; (2) System Code: 722222; UDI: 00884838099210; System Serial Number: 332, 111, 254, 256, 257, 265, 255, 100, 99, 310, 69, 12, 226, 15, 19, 23, 17, 55, 45, 187, 223, 358, 112, 113, 367, 120, 356, 262, 37, 318, 152, 364, 146, 246, 269, 75, 304, 316, 174, 230, 307, 320, 336, 338, 339, 340, 343, 344, 345, 346, 362, 308, 182, 27, 56, 312, 368, 172, 137, 302, 328, 35, 383, 96, 382, 151, 138, 384, 363, 224, 386, 395, 102, 118, 119, 145, 209, 210, 331, 351, 372, 373, 361, 88, 89, 108, 132, 48, 53, 4, 305, 80, 83, 47, 270, 21, 64, 22, 98, 29, 248, 266, 378, 245, 18, 24, 335, 177, 11, 72, 244, 9, 66, 50, 263, 65, 278, 82, 188, 68, 51, 5, 76, 243, 139, 319, 31, 193, 106, 392, 287, 178, 117, 267, 92, 324, 213, 281, 229, 215, 300, 268, 104, 353, 141, 133, 142, 105, 250, 251, 252, 253, 183, 375, 311, 228, 322, 189, 297, 190, 313, 169, 219, 247, 282, 217, 143, 349, 225, 162, 333, 185, 166, 161, 369, 134, 222, 389, 370, 374, 396, 399, 280, 249, 115, 321, 211, 168, 127, 261, 54, 14, 38, 10, 67, 165, 272, 326, 173, 90, 109, 13, 288, 289, 290, 291, 294, 295, 292, 186, 181, 107, 379, 385, 296, 314, 315, 390, 77, 354, 380, 110, 184, 180, 131, 284, 376, 366, 214, 116, 276, 73, 365, 398, 157, 87, 114, 274, 135, 159, 158, 78, 125, 218, 124, 126, 192, 212, 149; (3) System Code: 722230; UDI: 00884838116733; System Serial Number: 40, 2, 22, 10, 50, 4, 5, 19, 20, 23, 25, 30, 41, 67, 7, 45, 15, 28, 60, 38, 9, 62, 63, 57, 58, 54, 55, 39, 27, 52, 13, 12, 1, 68; (4) System Code: 722280; UDI: 00884838103276; System Serial Number: 57, 161, 43, 179, 229, 249, 65, 76, 232, 113, 167, 165, 80, 128, 158, 149, 194, 44, 100, 164, 240, 246, 66, 135, 175, 99, 112, 34, 79, 130, 48, 52, 141, 131, 142, 143, 144, 189, 37, 83, 223, 139, 87, 61, 259, 218, 90, 188, 105, 23, 30, 132, 96, 107, 171, 118, 21, 174, 220, 147, 133, 264, 38, 243, 177, 178, 150, 69, 148, 210, 207, 98, 211, 127, 222, 198, 71, 146, 241, 206, 152, 262, 157, 40, 17, 204, 260, 187, 208, 46, 235, 234, 91, 97, 153, 245, 106, 173, 258, 120, 45, 92, 226, 254, 213, 224, 95, 54, 126, 216, 19, 271, 215, 93, 24, 129, 74, 219, 88, 85, 86, 170, 55, 102, 123, 124, 125, 151, 39, 47, 101, 209, 41, 42, 53, 250, 239, 248, 108, 119, 205, 197, 82, 33, 20, 231, 63, 261, 138, 255, 212, 84, 221, 36, 247, 256, 59, 196, 50, 110, 199, 140, 68, 117, 49, 257, 60, 103, 237, 72, 160, 81, 114, 137, 58, 73, 35, 22, 94;
Apr 8, 2026
View details →Ultradent products, inc.
High PriorityActive
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
UDI-DI: E29270111. Lot: 529983. Expiration: 2031-09-02
Apr 8, 2026
View details →Civco medical instruments co. inc.
High PriorityActive
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
UDI-DI: 00841436111072; Lot Number: A276634
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722015; UDI: N/A; System Serial Number: 12, 16, 2, 8, 23, 3, 13; (2) System Code: 722023; UDI: 00884838059085; System Serial Number: 49, 41, 142, 110, 12, 179, 124, 27, 98, 66, 118, 117, 138, 42, 64, 116, 127, 175, 75, 82, 83, 46, 35, 109, 146, 33, 165, 169, 101, 103, 129, 10, 105, 90, 107, 100, 47, 159, 137, 119, 164, 70, 95, 177, 158, 5, 86, 34, 132, 9, 108, 121, 31, 112, 173, 114, 170, 172, 4, 14, 85, 13, 88, 25, 87, 94, 57, 125, 73, 106, 67, 16, 96, 58, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150; (3) System Code: 722035; UDI: 00884838054240; System Serial Number: 119, 126, 169, 72, 124, 161, 183, 242, 245, 246, 46, 196, 52, 236, 147, 172, 123, 74, 59, 60, 88, 30, 216, 212, 85, 21, 47, 222, 121, 131, 145, 127, 38, 187, 243, 143, 244, 125, 117, 100, 57, 247, 34, 165, 252, 101, 89, 192, 111, 128, 227, 144, 174, 28, 84, 130, 263, 132, 25, 98, 134, 35, 226, 190, 3, 6, 1, 249, 109, 251, 207, 158, 160, 237, 163, 79, 248, 253, 94, 80, 250, 154, 69, 97, 148, 170, 195, 26, 122, 96, 107, 142, 58, 166, 235, 230, 83, 53, 32, 164, 56, 40, 10, 11, 62, 265, 221, 257, 255, 229, 256, 254, 261, 260, 238, 113, 258, 241, 188, 259, 267, 167, 204, 43, 33, 37, 104, 233, 114, 108, 153, 70, 65, 191, 77, 110, 225, 75, 76, 193, 185, 186, 129, 103, 71, 151, 92, 201, 208, 149, 205, 19, 50, 51, 61, 211, 99, 12, 15, 198, 82, 105, 136, 194, 23, 200, 116, 48, 13, 106, 95, 206, 168, 203, 146, 81, 156, 45, 173, 49, 64, 171, 184, 102, 17, 215, 29, 231, 16, 202;
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Protective Sleeves.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8SL; UDI-DI (Product Code): 00840331271904 (SL8-R8SL). 2. Model Number: R8SL3; UDI-DI (Product Code): 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL; UDI-DI (Product Code): 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3; UDI-DI (Product Code): 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL; UDI-DI (Product Code): 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3; UDI-DI (Product Code): 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), 00840331272048 (SL38-U8SL3-XS).
Apr 8, 2026
View details →Recor medical inc.
High PriorityActive
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
Apr 8, 2026
View details →Mentor texas, lp.
High PriorityActive
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
UDI(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
1. DYNJ900898I UDI-DI 10198459273513 (EA) 40198459273514 (CS) LOTS 25DME064 25HMD841 25JMD489 25KME329 25KMH848 25LMC029 25LMH235 25LMK305 DYNJ901922G UDI-DI 10195327640422 (EA) 40195327640423 (CS) LOTS 24KBP812 2. DYKM1417I UDI-DI 10195327456757 (EA) 40195327456758 (CS) LOTS 24DLA405 24ELA912 24GLA871 24ILA151 24JLA326 DYKM1417J UDI-DI 10198459191640 (EA) 40198459191641 (CS) LOTS 25BLA761 25BLA886 25DLA353 25ELA056 25FLA429 25HLA196 25HLA242 25KLA388 25KLA610 3. DYNJ58146A UDI-DI 10193489611977 (EA) 40193489611978 (CS) LOTS 23KDA851 24ADC096 24CDB107 24DDB887 24IDA855 24JDB494 24LDA691 25BMF825 25DMD969 25FMC760 25GMD422 4. DYNDA2138A UDI-DI 10193489874594 (EA) 40193489874595 (CS) 24DBM325 24DBM383 25DBK159
Apr 8, 2026
View details →Intuitive surgical, inc.
High PriorityActive
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Lot Code: 420278: Grasping Retractor GTIN: 00886874111772 FDA Medical Listing Number: D088920 Material Number: 420278-04 Batch / System Numbers: M10110613 SH1182 M10120127 SH1182 M10120217 SH1182 M10120829 SH1182 M10130103 SH1182 M10130114 SH1182 M11130404 SH1182 M10130527 SH1182 M10130606 SH1182 M10130909 SH1182 M10130925 SH1182 S10101229 SG704 S10110105 SG704 M10121214 SH0547 M10110118 SH0059 M10110613 SH0059 S10110819 SH0059 M10121122 SH0059 M10121214 SH0059 M10130114 SH0059 M10130220 SH0059 M10130319 SH0059 M11130404 SH0059 M10120912 SH1390 M10130730 USG721 M10130909 USG721 M10110307 SH0729 M10130214 SH0729 M11130404 SH0729 M10130617 SH0729 M10130628 SH0729 M10120127 SH1076 M10130307 SH1279 M10111028 SH0761 Material Number: 420278-06 Batch / System Numbers: M10140115 SH1182 N10140725 SH1182 N10140923 SH1182 N10150324 SH1182 N10150417 SH1182 N10150721 SH1182 N10150608 SH1182 N10150820 SH1182 N10151113 SH1182 N10151214 SH1182 N10151029 SH1182 N10160304 SH1182 N10151201 SH1182 N10141205 SH1182 N10160921 SH1182 N10161123 SH1182 N10170516 SH1182 N10170601 SH1182 N10170921 SH1182 N10171213 SH1182 N10171226 SH1182 N10180417 SH1182 N10140815 SG704 N10150210 SG704 N10150608 SG704 N10160203 SG704 N10170117 SG704 N10170921 SG704 N10170822 SG704 N10171002 SG704 N10171226 SG704 M10140306 SH0059 N10141205 SH0059 N10150605 SH0059 N10170213 SH0059 N10171213 SH0059 N10171117 SH1964 N10180417 SH1964 N10170310 USG294 M10140306 USG721 M10140319 USG721 N10170412 USG721 N10180117 USG721 N10150224 SH1378 N10160203 SH1378 M10140306 SH0729 N10140828 SH0729 N10150330 SH0729 N10150319 SH0729 N10150525 SH0729 N10151020 SH0729 N10160503 SH0729 N10160524 SH0729 N10180417 SH0729 N10141001 SH1076 N10141030 SH1076 N10151211 SH1604 N10160524 SH1604 N10160801 SH1604 N10160921 SH1604 N10171226 SH1604 N10160921 SH1385 N10161010 SH1385 N10161114 SH1385 N10171117 SH1385 Material Number: 420278-07 Batch / System Numbers: N10181219 SH1182 N10180906 SH1182 N10190423 SH1182 N10181114 SH1182 N10180906 SG704 N10180910 USG721 N10181114 SH1604 Material Number: 420278-09 Batch / System Numbers: N10190826 SH1182 N10190515 SH1182 N10190909 SH1182 N10190902 SH1964 N10190826 SH1964 N10190515 SH1964 N10190909 SH1964 N10190826 USG721 N10190902 SH1604
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Allura Xper FD20/10; System Code: 722029;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
System Code: 722029; UDI: 00884838059078; System Serial Number: 57, 7, 88, 56, 126, 94, 30, 31, 21, 97, 91, 110, 100, 63, 60, 55, 62, 129, 71, 36, 26, 49, 114, 128, 108, 103, 107, 81, 43, 52, 119, 118, 80, 78, 47, 106, 123, 96, 122, 127, 14, 101, 116, 102, 115, 19, 109, 120, 92, 69, 27, 46, 93, 50, 51, 124, 87, 20, 32, 104, 34, 45, 59, 79, 24, 70, 39, 66, 82, 75, 40, 33, 23, 25, 85, 37, 44, 58, 38, 61, 98, 53, 89, 35, 48;
Apr 8, 2026
View details →Abiomed, inc.
High PriorityActive
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).
Increased risk of purge leaks with Generation 1 purge cassettes.
1. Code: 0043-0003. GTIN: 00813502011135. All Purge Cassette batches/lot numbers are affected. 2. Code: 004334. GTIN: 00813502011029. All Purge Cassette batches/lot numbers are affected. 3. Code: 0043-0002. GTIN: 00813502010510. All Purge Cassette batches/lot numbers are affected. Also included inside Code 0043-0003 above. Code 0043-0002 also includes innermost packaged with Code 0043-0001 (GTIN: 00813502011999). 4. Code: 004413 (Customer facing code 005040). GTIN: 00813502010947. All Purge Cassette batches/lot numbers are affected. 5. Code: 0046-0011. GTIN: 04260113630273. All Purge Cassette batches/lot numbers are affected. 6. Code: 0048-0002. GTIN: 04260113630242. All Purge Cassette batches/lot numbers are affected. 7. Code: 0048-0002-BR. GTIN: 00813502011777. All Purge Cassette batches/lot numbers are affected. 8. Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). GTIN: 04260113630280. All Purge Cassette batches/lot numbers are affected. Finished Good Batch Numbers: 2024309080, 2024309083, 2024309085, 2024309088, 2024309091, 2024309095, 2024309099, 2024309104, 2024309109, 2024309112, 2024309333, 2024309335, 2024309339, 2024309343, 2024309346, 2024309347, 2024309349, 2024309350, 2024309351, 2024309355, 2024310812, 2024310813, 2024310815, 2024310817, 2024310818, 2024310819, 2024310823, 2024310824, 2024310825, 2024310826, 2024317648, 2024317649, 2024317650, 2024317651, 2024317652, 2024317653, 2024317654, 2024317655, 2024317657, 2024317660, 2024324585, 2024324587, 2024324588, 2024324589, 2024324591, 2024324592, 2024324593, 2024324594, 2024324595, 2024324596, 2024328613, 2024328619, 2024328620, 2024328622, 2024328625, 2024328629, 2024328634, 2024328636, 2024328640, 2024328641, 2024328666, 2024328670, 2024328675, 2024328692, 2024328706, 2024328716, 2024328718, 2024328720, 2024328722, 2024328723, 2024328737, 2024328741, 2024328743, 2024328749, 2024328752, 2024328755, 2024328760, 2024328762, 2024328764, 2024328767, 2024328778, 2024328780, 2024328782, 2024328785, 2024328788, 2024328790, 2024328792, 2024328795, 2024328798, 2024328801, 2024328878, 2024328879, 2024328880, 2024328881, 2024328892, 2024328893, 2024328894, 2024328896, 2024328897, 2024328898, 2024328912, 2024328913, 2024328914, 2024328915, 2024328917, 2024328919, 2024328920, 2024328922, 2024328923, 2024328924, 2024329278, 2024329279, 2024329281, 2024329477, 2024329492, 2024329497, 2024329504, 2024329506, 2024329508, 2024329511, 2024329513, 2024329517, 2024329521, 2024329540, 2024329577, 2024329581, 2024329595, 2024329600, 2024329610, 2024329616, 2024329623, 2024329640, 2024329645, 2024329688, 2024329689, 2024329690, 2024329695, 2024329697, 2024329698, 2024329701, 2024329702, 2024329704, 2024329709, 2024329816, 2024329820, 2024329821, 2024329827, 2024329829, 2024329838, 2024329840, 2024329843, 2024329846, 2024329849, 2024330386, 2024330389, 2024330391, 2024330395, 2024330396, 2024330420, 2024330422, 2024330423, 2024330425, 2024330427, 2024330753, 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Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Real-Time Revel Insulin Pump: 00613994951502, 00763000161262, 00613994743930, 00643169077737, 00613994904485, 00643169202399, 00643169151369, 00643169478602, 00643169513914, 00643169933170, 00763000161132, 00643169464520: Artwork, CRB D Process, Paradigm REAL-Time Revel Insulin Pump UG (MP6025306-011A 1); Artwork, CRB D Process, Instr, X23 revel, EN (MP6025306-019 1)
Apr 8, 2026
View details →Mentor texas, lp.
High PriorityActive
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
10081317028335
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Kilt Blockers.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272727 (KILTBLOCKER8-R8KILTBLOCKER10X12). 2. Model Number: R8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011293 (KILTBLOCKER8-R8KILTBLOCKER12X12). 3. Model Number: R8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272741 (KILTBLOCKER8-R8KILTBLOCKER18X20). 4. Model Number: R8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272758 (KILTBLOCKER8-R8KILTBLOCKER20X24). 5. Model Number: R8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272765 (KILTBLOCKER8-R8KILTBLOCKER24X24). 6. Model Number: S8KILTBLOCKER10X10; UDI-DI (Product Code): 00840331272772 (KILTBLOCKER8-S8KILTBLOCKER10X10). 7. Model Number: S8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272789 (KILTBLOCKER8-S8KILTBLOCKER10X12). 8. Model Number: S8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011309 (KILTBLOCKER8-S8KILTBLOCKER12X12). 9. Model Number: S8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272802 (KILTBLOCKER8-S8KILTBLOCKER18X20). 10. Model Number: S8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272819 (KILTBLOCKER8-S8KILTBLOCKER20X24). 11. Model Number: S8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272826 (KILTBLOCKER8-S8KILTBLOCKER24X24). 12. Model Number: U8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011316 (KILTBLOCKER8-U8KILTBLOCKER12X12). 13. Model Number: U8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272864 (KILTBLOCKER8-U8KILTBLOCKER18X20). 14. Model Number: U8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272871 (KILTBLOCKER8-U8KILTBLOCKER20X24). 15. Model Number: U8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272888 (KILTBLOCKER8-U8KILTBLOCKER24X24).
Apr 8, 2026
View details →Mentor texas, lp.
High PriorityActive
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
00081317006671 00081317006794 00081317006800
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (case) ALL LOTS
Apr 8, 2026
View details →Siemens healthcare diagnostics, inc.
High PriorityActive
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
Siemens Material Number (SMN): 11097536; UDI-DI: 00630414220505; Lot numbers: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621;
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
ALLURA Xper FD10F; System Code: 722002;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
System Code: 722002; UDI: N/A; System Serial Number: 53, 61, 78, 38, 28, 63, 3, 81, 66, 40;
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Demi Half Aprons.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8DHALFR; UDI-DI (Product Code): 00197513001485 (DHALF8-R8DHALFR-L), 00197513001478 (DHALF8-R8DHALFR-M), 00197513001461 (DHALF8-R8DHALFR-S), 00197513001492 (DHALF8-R8DHALFR-XL), 00197513001607 (DHALFSET8-R8DHALFR-SET).
Apr 8, 2026
View details →Abiomed, inc.
High PriorityActive
Automated Impella Controller (AIC), labeled as the
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
All below with software version 8.2.2 through 8.5 are affected. 1. Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC2035, IC9416. 2. Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581. 3. Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312. 4. Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC1140. 5. Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683. 6. Code: 0042-0010-UK; GTIN: 00813502010978; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440. 7. Code: 0042-0040-CA; GTIN: 00813502012958; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894. 8. Code: 0042-0040-EU; GTIN: 00813502012217; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425. 9. Code: 0042-0040-AU; GTIN: 00813502012972; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151.
Apr 8, 2026
View details →Olympus corporation of the americas
High PriorityActive
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Laser system: TFL-PLS; UDI: 00821925044111; Component Part: TFL-CPLU; UDI: 00821925044586; Serial #: MDUF220005, MDUF220005, MDUF220437, MDUF220437, MDUF220446, MDUF220446, MDUF190072, MDUF200324, MDUF210030, MDUF210204, MDUF210379, MDUF220001, MDUF220002, MDUF220003, MDUF220007, MDUF220008, MDUF220009, MDUF220010, MDUF220011, MDUF220012, MDUF220013, MDUF220014, MDUF220015, MDUF220016, MDUF220017, MDUF220018, MDUF220019, MDUF220020, MDUF220021, MDUF220022, MDUF220023, MDUF220024, MDUF220025, MDUF220026, MDUF220027, MDUF220028, MDUF220029, MDUF220030, MDUF220031, MDUF220032, MDUF220033, MDUF220034, MDUF220035, MDUF220036, MDUF220037, MDUF220038, MDUF220039, MDUF220040, MDUF220042, MDUF220043, MDUF220044, MDUF220045, MDUF220046, MDUF220047, MDUF220048, MDUF220049, MDUF220050, MDUF220051, MDUF220052, MDUF220053, MDUF220054, MDUF220055, MDUF220056, MDUF220057, MDUF220058, MDUF220060, MDUF220061, MDUF220062, MDUF220063, MDUF220064, MDUF220065, MDUF220066, MDUF220067, MDUF220069, MDUF220070, MDUF220071, MDUF220072, MDUF220074, MDUF220075, MDUF220076, MDUF220077, MDUF220078, MDUF220079, MDUF220080, MDUF220081, MDUF220082, MDUF220083, MDUF220084, MDUF220085, MDUF220086, MDUF220087, MDUF220088, MDUF220089, MDUF220090, MDUF220091, MDUF220092, MDUF220093, MDUF220094, MDUF220095, MDUF220096, MDUF220097, MDUF220098, MDUF220100, MDUF220101, MDUF220102, MDUF220103, MDUF220106, MDUF220109, MDUF220110, MDUF220111, MDUF220113, MDUF220114, MDUF220115, MDUF220116, MDUF220117, MDUF220119, MDUF220120, MDUF220123, MDUF220124, MDUF220126, MDUF220127, MDUF220128, MDUF220130, MDUF220131, MDUF220133, MDUF220135, MDUF220137, MDUF220138, MDUF220139, MDUF220140, MDUF220141, MDUF220142, MDUF220143, MDUF220144, MDUF220145, MDUF220146, MDUF220147, MDUF220149, MDUF220150, MDUF220151, MDUF220152, MDUF220153, MDUF220154, MDUF220155, MDUF220156, MDUF220157, MDUF220158, MDUF220159, MDUF220160, MDUF220161, MDUF220162, MDUF220163, MDUF220164, MDUF220165, MDUF220166, MDUF220167, MDUF220168, MDUF220170, MDUF220171, MDUF220172, MDUF220173, MDUF220174, MDUF220175, MDUF220176, MDUF220177, MDUF220178, MDUF220179, MDUF220180, MDUF220181, MDUF220182, MDUF220183, MDUF220184, MDUF220185, MDUF220186, MDUF220187, MDUF220188, MDUF220189, MDUF220190, MDUF220191, MDUF220192, MDUF220193, MDUF220194, MDUF220195, MDUF220196, MDUF220198, MDUF220199, MDUF220200, MDUF220201, MDUF220202, MDUF220203, MDUF220204, MDUF220205, MDUF220206, MDUF220207, MDUF220208, MDUF220209, MDUF220210, MDUF220211, MDUF220212, MDUF220213, MDUF220214, MDUF220216, MDUF220217, MDUF220218, MDUF220219, MDUF220220, MDUF220221, MDUF220222, MDUF220223, MDUF220224, MDUF220225, MDUF220226, MDUF220227, MDUF220228, MDUF220229, MDUF220230, MDUF220231, MDUF220232, MDUF220233, MDUF220234, MDUF220235, MDUF220237, MDUF220238, MDUF220240, MDUF220241, MDUF220242, MDUF220243, MDUF220244, MDUF220245, MDUF220246, MDUF220247, MDUF220248, MDUF220249, MDUF220250, MDUF220251, MDUF220252, MDUF220253, MDUF220254, MDUF220255, MDUF220256, MDUF220257, MDUF220258, MDUF220259, MDUF220260, MDUF220261, MDUF220262, MDUF220263, MDUF220264, MDUF220265, MDUF220266, MDUF220267, MDUF220268, MDUF220269, MDUF220270, MDUF220271, MDUF220272, MDUF220273, MDUF220274, MDUF220275, MDUF220276, MDUF220277, MDUF220278, MDUF220279, MDUF220280, MDUF220281, MDUF220283, MDUF220284, MDUF220285, MDUF220286, MDUF220287, MDUF220288, MDUF220289, MDUF220291, MDUF220292, MDUF220294, MDUF220295, MDUF220296, MDUF220297, MDUF220298, MDUF220299, MDUF220300, MDUF220301, MDUF220302, MDUF220303, MDUF220304, MDUF220305, MDUF220306, MDUF220307, MDUF220308, MDUF220309, MDUF220310, MDUF220311, MDUF220312, MDUF220313, MDUF220314, MDUF220315, MDUF220316, MDUF220317, MDUF220318, MDUF220320, MDUF220321, MDUF220322, MDUF220323, MDUF220324, MDUF220326, MDUF220327, MDUF220328, MDUF220329, MDUF220330, MDUF220332, MDUF220333, MDUF220334, MDUF220335, MDUF220336, MDUF220337, MDUF220338, MDUF220339, MDUF220340, MDUF220341, MDUF220342, MDUF220343, MDUF220344, MDUF220345, MDUF220346, MDUF220347, MDUF220348, MDUF220349, MDUF220350, MDUF220351, MDUF220358, MDUF220359, MDUF220360, MDUF220361, MDUF220362, MDUF220364, MDUF220365, MDUF220366, MDUF220367, MDUF220368, MDUF220370, MDUF220371, MDUF220373, MDUF220374, MDUF220375, MDUF220377, MDUF220378, MDUF220379, MDUF220380, MDUF220381, MDUF220382, MDUF220383, MDUF220384, MDUF220385, MDUF220388, MDUF220389, MDUF220391, MDUF220392, MDUF220394, MDUF220397, MDUF220399, MDUF220400, MDUF220402, MDUF220403, MDUF220404, MDUF220405, MDUF220406, MDUF220407, MDUF220408, MDUF220409, MDUF220410, MDUF220415, MDUF220416, MDUF220417, MDUF220418, MDUF220419, MDUF220420, MDUF220421, MDUF220423, MDUF220424, MDUF220425, MDUF220426, MDUF220428, MDUF220429, MDUF220431, MDUF220432, MDUF220433, MDUF220434, MDUF220435, MDUF220436, MDUF220438, MDUF220439, MDUF220440, MDUF220441, MDUF220442, MDUF220443, MDUF220444, MDUF220445, MDUF220448, MDUF220449, MDUF220450, MDUF220457, MDUF220458, MDUF220459, MDUF220460, MDUF220461, MDUF220462, MDUF220463, MDUF220464, MDUF220465, MDUF220466, MDUF220468, MDUF220469, MDUF220470, MDUF220471, MDUF220473, MDUF220476, MDUF220478, MDUF220481, MDUF220482, MDUF220483, MDUF220484, MDUF220485, MDUF220486, MDUF220488, MDUF220489, MDUF220492, MDUF220493, MDUF220494, MDUF220495, MDUF220496, MDUF220497, MDUF220498, MDUF220499, MDUF220500, MDUF220501, MDUF220502, MDUF220504, MDUF220505, MDUF220506, MDUF220507, MDUF220508, MDUF220509, MDUF220511, MDUF220512, MDUF220513, MDUF220515, MDUF220517, MDUF220518, MDUF220519, MDUF220520, MDUF220521, MDUF220523, MDUF220524, MDUF220525, MDUF220526, MDUF220527, MDUF220528, MDUF220530, MDUF220531, MDUF220532, MDUF220533, MDUF220534, MDUF220535, MDUF220536, MDUF220537, MDUF220538, MDUF220539, MDUF220541, MDUF220542, MDUF220543, MDUF220545, MDUF220546, MDUF220548, MDUF220550, MDUF220551, MDUF220552, MDUF220553, MDUF220554, MDUF220555, MDUF220556, MDUF220557, MDUF220558, MDUF220559, MDUF220560, MDUF220562, MDUF220563, MDUF220564, MDUF220565, MDUF220567, MDUF220568, MDUF220569, MDUF220570, MDUF220571, MDUF220572, MDUF220573, MDUF220574, MDUF220575, MDUF220576, MDUF220577, MDUF220578, MDUF220579, MDUF220580, MDUF220581, MDUF220582, MDUF220583, MDUF220584, MDUF220585, MDUF220586, MDUF220588, MDUF230002, MDUF230003, MDUF230008, MDUF230010, MDUF230011, MDUF230012, MDUF230014, MDUF230015, MDUF230016, MDUF230017, MDUF230019, MDUF230020, MDUF230021, MDUF230022, MDUF230023, MDUF230024, MDUF230025, MDUF230028, MDUF230030, MDUF230031, MDUF230032, MDUF230033, MDUF230034, MDUF230035, MDUF230036, MDUF230037, MDUF230038, MDUF230039, MDUF230040, MDUF230041, MDUF230042, MDUF230043, MDUF230044, MDUF230045, MDUF230046, MDUF230047, MDUF230048, MDUF230049, MDUF230050, MDUF230052, MDUF230053, MDUF230054, MDUF230055, MDUF230056, MDUF230057, MDUF230060, MDUF230061, MDUF230062, MDUF230064, MDUF230065, MDUF230067, MDUF230069, MDUF230070, MDUF230071, MDUF230072, MDUF230073, MDUF230074, MDUF230075, MDUF230077, MDUF230078, MDUF230079, MDUF230080, MDUF230081, MDUF230082, MDUF230084, MDUF230085, MDUF230086, MDUF230087, MDUF230088, MDUF230089, MDUF230090, MDUF230091, MDUF230092, MDUF230093, MDUF230094, MDUF230095, MDUF230096, MDUF230097, MDUF230098, MDUF230099, MDUF230102, MDUF230103, MDUF230104, MDUF230105, MDUF230106, MDUF230107, MDUF230108, MDUF230109, MDUF230110, MDUF230111, MDUF230112, MDUF230113, MDUF230114, MDUF230115, MDUF230116, MDUF230117, MDUF230118, MDUF230119, MDUF230120, MDUF230121, MDUF230122, MDUF230123, MDUF230124, MDUF230125, MDUF230126, MDUF230127, MDUF230128, MDUF230129, MDUF230130, MDUF230131, MDUF230132, MDUF230133, MDUF230134, MDUF230136, MDUF230137, MDUF230138, MDUF230139, MDUF230142, MDUF230143, MDUF230144, MDUF230145, MDUF230146, MDUF230147, MDUF230148, MDUF230149, MDUF230150, MDUF230151, MDUF230152, MDUF230153, MDUF230154, MDUF230156, MDUF230157, MDUF230158, MDUF230159, MDUF230160, MDUF230161, MDUF230162, MDUF230165, MDUF230168, MDUF230169, MDUF230170, MDUF230171, MDUF230172, MDUF230173, MDUF230174, MDUF230175, MDUF230176, MDUF230177, MDUF230178, MDUF230179, MDUF230180, MDUF230181, MDUF230182, MDUF230183, MDUF230184, MDUF230185, MDUF230186, MDUF230187, MDUF230188, MDUF230189, MDUF230190, MDUF230191, MDUF230192, MDUF230193, MDUF230194, MDUF230195, MDUF230196, MDUF230197, MDUF230198, MDUF230199, MDUF230200, MDUF230201, MDUF230202, MDUF230203, MDUF230204, MDUF230205, MDUF230206, MDUF230207, MDUF230208, MDUF230209, MDUF230210, MDUF230211, MDUF230212, MDUF230213, MDUF230214, MDUF230215, MDUF230216, MDUF230218, MDUF230219, MDUF230220, MDUF230221, MDUF230222, MDUF230223, MDUF230224, MDUF230226, MDUF230227, MDUF230228, MDUF230229, MDUF230230, MDUF230231, MDUF230232, MDUF230233, MDUF230235, MDUF230236, MDUF230237, MDUF230238, MDUF230239, MDUF230240, MDUF230241, MDUF230242, MDUF230243, MDUF230244, MDUF230245, MDUF230246, MDUF230247, MDUF230248, MDUF230249, MDUF230250, MDUF230251, MDUF230252, MDUF230253, MDUF230254, MDUF230255, MDUF230256, MDUF230257, MDUF230258, MDUF230259, MDUF230260, MDUF230261, MDUF230262, MDUF230263, MDUF230264, MDUF230265, MDUF230266, MDUF230267, MDUF230268, MDUF230269, MDUF230270, MDUF230272, MDUF230274, MDUF230275, MDUF230276, MDUF230277, MDUF230278, MDUF230279, MDUF230280, MDUF230281, MDUF230282, MDUF230286, MDUF230287, MDUF230288, MDUF230289, MDUF230290, MDUF230291, MDUF230292, MDUF230293, MDUF230294, MDUF230295, MDUF230296, MDUF230297, MDUF230298, MDUF230299, MDUF230300, MDUF230301, MDUF230302, MDUF230303, MDUF230304, MDUF230305, MDUF230306, MDUF230307, MDUF230308, MDUF230309, MDUF230310, MDUF230311, MDUF230314, MDUF230316, MDUF230317, MDUF230318, MDUF230319, MDUF230320, MDUF230321, MDUF230322, MDUF230324, MDUF230325, MDUF230326, MDUF230327, MDUF230328, MDUF230330, MDUF230333, MDUF230334, MDUF230335, MDUF230336, MDUF230337, MDUF230338, MDUF230339, MDUF230341, MDUF230342, MDUF230343, MDUF230344, MDUF230345, MDUF230346, MDUF230347, MDUF230348, MDUF230349, MDUF230350, MDUF230351, MDUF230352, MDUF230353, MDUF230354, MDUF230355, MDUF230356, MDUF230357, MDUF230358, MDUF230359, MDUF230360, MDUF230367, MDUF230368, MDUF230369, MDUF230370, MDUF230371, MDUF230372, MDUF230373, MDUF230374, MDUF230375, MDUF230376, MDUF230377, MDUF230379, MDUF230380, MDUF230381, MDUF230382, MDUF230383, MDUF230384, MDUF230385, MDUF230386, MDUF230387, MDUF230388, MDUF230389, MDUF230390, MDUF230391, MDUF230392, MDUF230393, MDUF230394, MDUF230395, MDUF230396, MDUF230397, MDUF230398, MDUF230399, MDUF230400, MDUF230401, MDUF230402, MDUF230404, MDUF230405, MDUF230406, MDUF230407, MDUF230408, MDUF230409, MDUF230410, MDUF230414, MDUF230417, MDUF230418, MDUF230419, MDUF230420, MDUF230421, MDUF230422, MDUF230423, MDUF230424, MDUF230425, MDUF230426, MDUF230427, MDUF230428, MDUF230429, MDUF230430, MDUF230431, MDUF230432, MDUF230433, MDUF230434, MDUF230435, MDUF230436, MDUF230437, MDUF230438, MDUF240001, MDUF240002, MDUF240003, MDUF240004, MDUF240005, MDUF240006, MDUF240007, MDUF240008, MDUF240009, MDUF240012, MDUF240013, MDUF240014, MDUF240015, MDUF240016, MDUF240017, MDUF240018, MDUF240019, MDUF240020, MDUF240021, MDUF240022, MDUF240024, MDUF240025, MDUF240026, MDUF240027, MDUF240028, MDUF240029, MDUF240030, MDUF240031;
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 740G Insulin Pump: 763000504908, 763000504915, 763000505073, 763000484637, 763000505042, 763000504861, 763000629984, 763000504946, 763000504878, 763000559557, 763000504960, 763000505080, 763000505066, 763000629991, 763000505004, 763000504922, 763000504892, 763000505059, 763000504977, 763000505028, 763000505172, 763000505127, 763000505134, 763000505158, 763000505141, 763000505103, 763000505110, 763000504991, 763000505165, 763000504939, 763000504953, 763000504984, 763000505189, 763000851224, 763000851217, 763000769451, 763000769468: MINIMED 740G SYSTEM USER GUIDE mg/dL(M000149C002 1, M000149C004 1, M000149C005 1, M000150C005 1, M000150C002 1, M000150C021 2, M000149C016 1, M000149C021 1, M000150C004 1, M000150C025 1, M000150C030 1, M000149C014 1, M000149C006 1, M000150C003 1, M000150C015 1, M000150C028 1, M000150C018 1, M000150C022 1, M000150C007 1, M000149C017 1, M000149C008 1, M000150C008 1, M000150C032 1, M000150C029 1, M000150C012 1, M000150C016 1, M000150C010 1, M000149C011 1, M046726C001 3, M046726C002 3, M000149C020 1, M000149C025 1, M000150C024 1, M000150C023 1, M000150C013 1).
Apr 8, 2026
View details →Civco medical instruments co. inc.
High PriorityActive
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
UDI-DI: 00841436111041; Lot Number: A228673
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722020; UDI: N/A; System Serial Number: 4; (2) System Code: 722025; UDI: 00884838059108; System Serial Number: 6, 2, 3;
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Vest
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8PVEST; UDI-DI (Product Code): 00840331297652 (VESTC18-C8PVEST-2XM ), 00840331297652 (VESTC8-C8PVEST-LF ), 00840331297652 (VESTC8-C8PVEST-LM ), 00840331297652 (VESTC8-C8PVEST-MF ), 00840331297652 (VESTC8-C8PVEST-MM ), 00840331297652 (VESTC8-C8PVEST-SF ), 00840331297652 (VESTC8-C8PVEST-SM ), 00840331297652 (VESTC8-C8PVEST-XLM ), 00840331297652 (VESTT18-C8PVEST-LF ), 00840331297652 (VESTT18-C8PVEST-LM ), 00840331297652 (VESTT18-C8PVEST-MM ), 00840331297652 (VESTT18-C8PVEST-PLUS ), 00840331297652 (VESTT18-C8PVEST-SM ), 00840331297652 (VESTT28-C8PVEST-3XM ), 00840331297652 (VESTT28-C8PVEST-4XM ), 00840331297652 (VESTT28-C8PVEST-5XM ). 2. Model Number: C8VEST; UDI-DI (Product Code): 00840331297645 (VESTC18-C8VEST-2XM ), 00840331297645 (VESTC8-C8VEST-LF ), 00840331297645 (VESTC8-C8VEST-LM ), 00840331297645 (VESTC8-C8VEST-MF ), 00840331297645 (VESTC8-C8VEST-MM ), 00840331297645 (VESTC8-C8VEST-PLUS ), 00840331297645 (VESTC8-C8VEST-SF ), 00840331297645 (VESTC8-C8VEST-SM ), 00840331297645 (VESTC8-C8VEST-XLF ), 00840331297645 (VESTC8-C8VEST-XLM ), 00840331297645 (VESTC8-C8VEST-XSF ), 00840331297645 (VESTT18-C8VEST-LM ), 00840331297645 (VESTT18-C8VEST-MM ), 00840331297645 (VESTT18-C8VEST-SM ), 00840331297645 (VESTT18-C8VEST-XLM ), 00840331297645 (VESTT18-C8VEST-XSM ), 00840331297645 (VESTT28-C8VEST-2XM ), 00840331297645 (VESTT28-C8VEST-4XF ). 3. Model Number: R8FVEST; UDI-DI (Product Code): 00840331259520 (VESTC18-R8FVEST-2XF ), 00840331259537 (VESTC18-R8FVEST-2XM ), 00840331259551 (VESTC18-R8FVEST-3XM ), 00840331259568 (VESTC8-R8FVEST-LF ), 00840331259575 (VESTC8-R8FVEST-LM ), 00840331259582 (VESTC8-R8FVEST-MF ), 00840331259599 (VESTC8-R8FVEST-MM ), 00840331259605 (VESTC8-R8FVEST-PLUS ), 00840331259612 (VESTC8-R8FVEST-SF ), 00840331259629 (VESTC8-R8FVEST-SM ), 00840331259636 (VESTC8-R8FVEST-XLF ), 00840331259643 (VESTC8-R8FVEST-XLM ), 00840331259650 (VESTC8-R8FVEST-XSF ), 00840331269741 (VESTT18-R8FVEST-LF ), 00840331269758 (VESTT18-R8FVEST-LM ), 00840331269741 (VESTT18-R8FVEST-MF ), 00840331269758 (VESTT18-R8FVEST-MM ), 00840331269741 (VESTT18-R8FVEST-PLUS ), 00840331269741 (VESTT18-R8FVEST-SF ), 00840331269758 (VESTT18-R8FVEST-SM ), 00840331269741 (VESTT18-R8FVEST-XLF ), 00840331269758 (VESTT18-R8FVEST-XLM ), 00840331269758 (VESTT18-R8FVEST-XSM ), 00840331269741 (VESTT28-R8FVEST-2XF ), 00840331269758 (VESTT28-R8FVEST-2XM ), 00840331269741 (VESTT28-R8FVEST-3XF ), 00840331269758 (VESTT28-R8FVEST-3XM ), 00840331269741 (VESTT28-R8FVEST-4XF ), 00840331269758 (VESTT28-R8FVEST-4XM ), 00840331269741 (VESTT28-R8FVEST-5XF ), 00840331269758 (VESTT28-R8FVEST-5XM ), 00840331269741 (VESTT38-R8FVEST-6XF ), 00840331269758 (VESTT38-R8FVEST-6XM ), 00840331269741 (VESTT38-R8FVEST-8XF ), 00840331269758 (VESTT38-R8FVEST-8XM ), None (IVESTC8-R8FVEST-MFR ), None (IVESTC8-R8FVEST-MML ), None (IVESTC8-R8FVEST-LFL ), None (IVESTC8-R8FVEST-LFR ), None (IVESTC8-R8FVEST-LML ), None (IVESTC8-R8FVEST-MMR ), None (IVESTC8-R8FVEST-PLUSL ), None (IVESTC8-R8FVEST-SFR ), None (IVESTC8-R8FVEST-SFS ), None (IVESTC8-R8FVEST-SMR ), None (IVESTC8-R8FVEST-SMS ), None (IVESTC8-R8FVEST-XLML ), None (IVESTC8-R8FVEST-XSFS ), None (IVESTC8-R8FVEST-MMXL ), None (IVESTC8-R8FVEST-XLMXL ), None (IVESTC8-R8FVEST-LMR ), None (IVESTC8-R8FVEST-XSFR ), None (IVESTC8-R8FVEST-XSMR ). 4. Model Number: R8PVEST; UDI-DI (Product Code): None (IVESTC8-R8PVEST-LMR ), None (IVESTC8-R8PVEST-SMR ), 00840331259841 (VESTC18-R8PVEST-2XF ), 00840331259858 (VESTC18-R8PVEST-2XM ), 00840331259865 (VESTC18-R8PVEST-3XF ), 00840331259872 (VESTC18-R8PVEST-3XM ), 00840331259889 (VESTC8-R8PVEST-LF ), 00840331259896 (VESTC8-R8PVEST-LM ), 00840331259902 (VESTC8-R8PVEST-MF ), 00840331259919 (VESTC8-R8PVEST-MM ), 00840331259926 (VESTC8-R8PVEST-PLUS ), 00840331259933 (VESTC8-R8PVEST-SF ), 00840331259940 (VESTC8-R8PVEST-SM ), 00840331259957 (VESTC8-R8PVEST-XLF ), 00840331259964 (VESTC8-R8PVEST-XLM ), 00840331259971 (VESTC8-R8PVEST-XSF ), 00840331259988 (VESTC8-R8PVEST-XSM ), 00840331269680 (VESTT18-R8PVEST-LF ), 00840331269697 (VESTT18-R8PVEST-LM ), 00840331269680 (VESTT18-R8PVEST-MF ), 00840331269697 (VESTT18-R8PVEST-MM ), 00840331269680 (VESTT18-R8PVEST-PLUS ), 00840331269680 (VESTT18-R8PVEST-SF ), 00840331269697 (VESTT18-R8PVEST-SM ), 00840331269680 (VESTT18-R8PVEST-XLF ), 00840331269697 (VESTT18-R8PVEST-XLM ), 00840331269697 (VESTT18-R8PVEST-XSM ), 00840331269680 (VESTT28-R8PVEST-2XF ), 00840331269697 (VESTT28-R8PVEST-2XM ), 00840331269680 (VESTT28-R8PVEST-3XF ), 00840331269697 (VESTT28-R8PVEST-3XM ), 00840331269680 (VESTT28-R8PVEST-4XF ), 00840331269697 (VESTT28-R8PVEST-4XM ), 00840331269680 (VESTT28-R8PVEST-5XF ), 00840331269697 (VESTT28-R8PVEST-5XM ), 00840331269680 (VESTT38-R8PVEST-6XF ), 00840331269697 (VESTT38-R8PVEST-6XM ), 00840331269680 (VESTT38-R8PVEST-7XF ), 00840331269697 (VESTT38-R8PVEST-7XM ), 00840331269680 (VESTT38-R8PVEST-8XF ), 00840331269697 (VESTT38-R8PVEST-8XM ), None (IVESTC8-R8PVEST-LFR ), None (IVESTC8-R8PVEST-MFL ), None (IVESTC8-R8PVEST-MFR ), None (IVESTC8-R8PVEST-MML ), None (IVESTC8-R8PVEST-MMR ), None (IVESTC8-R8PVEST-SFR ), None (IVESTC8-R8PVEST-XSFR ), None (IVESTC8-R8PVEST-2XFR ), None (IVESTC8-R8PVEST-LML ), None (IVESTC8-R8PVEST-LMXL ), None (IVESTC8-R8PVEST-MFS ), None (IVESTC8-R8PVEST-SFL ), None (IVESTC8-R8PVEST-SFS ), None (IVESTC8-R8PVEST-XLFL ), None (IVESTC8-R8PVEST-XLMR ). 5. Model Number: R8QVEST; UDI-DI (Product Code): 00840331260076 (QVESTC18-R8QVEST-LF ), 00840331260083 (QVESTC18-R8QVEST-MF ), None (QVESTC18-R8QVEST-PLUS ), 00840331260106 (QVESTC18-R8QVEST-SF ), 00840331260113 (QVESTC18-R8QVEST-XLF ), 00840331260007 (QVESTC28-R8QVEST-2XF ), 00840331269802 (QVESTT18-R8QVEST-LF ), 00840331269802 (QVESTT18-R8QVEST-MF ), 00840331269802 (QVESTT18-R8QVEST-PLUS ), 00840331269802 (QVESTT18-R8QVEST-SF ), 00840331269802 (QVESTT18-R8QVEST-XLF ), 00840331269802 (QVESTT28-R8QVEST-2XF ), 00840331269802 (QVESTT28-R8QVEST-3XF ), 00840331269802 (QVESTT28-R8QVEST-4XF ), 00840331269802 (QVESTT28-R8QVEST-5XF ), 00840331269802 (QVESTT38-R8QVEST-8XF ), None (IQVESTC8-R8QVEST-SFR ), 00840331260120 (QVESTC18-R8QVEST-XSF ), None (IQVESTC8-R8QVEST-MFR). 6. Model Number: R8VEST; UDI-DI (Product Code): 00840331261752 (VESTC18-R8VEST-2XF ), 00840331261769 (VESTC18-R8VEST-2XM ), 00840331261776 (VESTC18-R8VEST-3XF ), 00840331261783 (VESTC18-R8VEST-3XM ), 00840331261790 (VESTC8-R8VEST-LF ), 00840331261806 (VESTC8-R8VEST-LM ), 00840331261813 (VESTC8-R8VEST-MF ), 00840331261820 (VESTC8-R8VEST-MM ), 00840331261837 (VESTC8-R8VEST-PLUS ), 00840331261844 (VESTC8-R8VEST-SF ), 00840331261851 (VESTC8-R8VEST-SM ), 00840331261868 (VESTC8-R8VEST-XLF ), 00840331261875 (VESTC8-R8VEST-XLM ), 00840331261882 (VESTC8-R8VEST-XSF ), 00840331261899 (VESTC8-R8VEST-XSM ), 00840331261790 (VESTS8-R8VEST-LF ), 00840331261806 (VESTS8-R8VEST-LM ), 00840331261813 (VESTS8-R8VEST-MF ), 00840331261820 (VESTS8-R8VEST-MM ), 00840331261837 (VESTS8-R8VEST-PLUS ), 00840331261844 (VESTS8-R8VEST-SF ), 00840331261851 (VESTS8-R8VEST-SM ), 00840331261868 (VESTS8-R8VEST-XLF ), 00840331261875 (VESTS8-R8VEST-XLM ), 00840331269628 (VESTT18-R8VEST-LF ), 00840331269635 (VESTT18-R8VEST-LM ), 00840331269628 (VESTT18-R8VEST-MF ), 00840331269635 (VESTT18-R8VEST-MM ), 00840331269628 (VESTT18-R8VEST-PLUS ), 00840331269628 (VESTT18-R8VEST-SF ), 00840331269635 (VESTT18-R8VEST-SM ), 00840331269628 (VESTT18-R8VEST-XLF ), 00840331269635 (VESTT18-R8VEST-XLM ), 00840331269628 (VESTT18-R8VEST-XSF ), 00840331269635 (VESTT18-R8VEST-XSM ), 00840331269628 (VESTT28-R8VEST-2XF ), 00840331269635 (VESTT28-R8VEST-2XM ), 00840331269628 (VESTT28-R8VEST-3XF ), 00840331269635 (VESTT28-R8VEST-3XM ), 00840331269628 (VESTT28-R8VEST-4XF ), 00840331269635 (VESTT28-R8VEST-4XM ), 00840331269628 (VESTT28-R8VEST-5XF ), 00840331269635 (VESTT28-R8VEST-5XM ), 00840331269628 (VESTT38-R8VEST-6XF ), 00840331269635 (VESTT38-R8VEST-6XM ), 00840331269628 (VESTT38-R8VEST-7XF ), 00840331269635 (VESTT38-R8VEST-7XM ), 00840331269628 (VESTT38-R8VEST-8XF ), 00840331269635 (VESTT38-R8VEST-8XM ), None (IVESTC8-R8VEST-LFR ), None (IVESTC8-R8VEST-LMR ), None (IVESTC8-R8VEST-MMR ), None (IVESTC8-R8VEST-SMS ), None (IVESTC8-R8VEST-MFR ), None (IVESTC8-R8VEST-SFR), None (IVESTC8-R8VEST-LML ), None (IVESTC8-R8VEST-SMR ). 7. Model Number: R8ZVEST; UDI-DI (Product Code): 00840331262063 (ZVESTC18-R8ZVEST-LM), 00840331262087 (ZVESTC18-R8ZVEST-MM), 00840331262087 (ZVESTC18-R8ZVEST-SF), 00840331262148 (ZVESTC18-R8ZVEST-XSF), 00840331269840 (ZVESTT18-R8ZVEST-LM), 00840331269833 (ZVESTT18-R8ZVEST-PLUS), 00840331269840 (ZVESTT28-R8ZVEST-2XM), 00840331269833 (ZVESTT28-R8ZVEST-3XF), None (IZVESTC8-R8ZVEST-LFR). 8. Model Number: S8FVEST; UDI-DI (Product Code): 00840331263275 (VESTC18-S8FVEST-2XF ), 00840331263305 (VESTC18-S8FVEST-3XM ), 00840331263312 (VESTC8-S8FVEST-LF ), 00840331263329 (VESTC8-S8FVEST-LM ), 00840331263336 (VESTC8-S8FVEST-MF ), 00840331263343 (VESTC8-S8FVEST-MM ), 00840331263350 (VESTC8-S8FVEST-PLUS ), 00840331263367 (VESTC8-S8FVEST-SF ), 00840331263374 (VESTC8-S8FVEST-SM ), 00840331263381 (VESTC8-S8FVEST-XLF ), 00840331263398 (VESTC8-S8FVEST-XLM ), 00840331269765 (VESTT18-S8FVEST-LF ), 00840331269772 (VESTT18-S8FVEST-LM ), 00840331269765 (VESTT18-S8FVEST-MF ), 00840331269772 (VESTT18-S8FVEST-MM ), 00840331269765 (VESTT18-S8FVEST-PLUS ), 00840331269765 (VESTT18-S8FVEST-SF ), 00840331269772 (VESTT18-S8FVEST-SM ), 00840331269765 (VESTT18-S8FVEST-XLF ), 00840331269772 (VESTT18-S8FVEST-XLM ), 00840331269772 (VESTT28-S8FVEST-2XM ), 00840331269765 (VESTT28-S8FVEST-3XF ), 00840331269772 (VESTT28-S8FVEST-3XM ), 00840331269765 (VESTT28-S8FVEST-4XF ), 00840331269772 (VESTT28-S8FVEST-4XM ), 00840331269765 (VESTT28-S8FVEST-5XF ), 00840331269772 (VESTT28-S8FVEST-5XM ), 00840331269765 (VESTT38-S8FVEST-6XF ), 00840331269772 (VESTT38-S8FVEST-6XM ), 00840331269765 (VESTT38-S8FVEST-7XF ), 00840331269765 (VESTT38-S8FVEST-8XF ). 9. Model Number: S8PVEST; UDI-DI (Product Code): 00840331263596 (VESTC18-S8PVEST-2XF ), 00840331263602 (VESTC18-S8PVEST-2XM ), 00840331263633 (VESTC8-S8PVEST-LF ), 00840331263640 (VESTC8-S8PVEST-LM ), 00840331263657 (VESTC8-S8PVEST-MF ), 00840331263664 (VESTC8-S8PVEST-MM ), 00840331263671 (VESTC8-S8PVEST-PLUS ), 00840331263688 (VESTC8-S8PVEST-SF ), 00840331263695 (VESTC8-S8PVEST-SM ), 00840331263701 (VESTC8-S8PVEST-XLF ), 00840331263718 (VESTC8-S8PVEST-XLM ), 00840331269703 (VESTT18-S8PVEST-LF ), 00840331269710 (VESTT18-S8PVEST-LM ), 00840331269703 (VESTT18-S8PVEST-MF ), 00840331269710 (VESTT18-S8PVEST-MM ), 00840331269703 (VESTT18-S8PVEST-PLUS ), 00840331269703 (VESTT18-S8PVEST-SF ), 00840331269710 (VESTT18-S8PVEST-SM ), 00840331269703 (VESTT18-S8PVEST-XLF ), 00840331269710 (VESTT18-S8PVEST-XLM ), 00840331269710 (VESTT18-S8PVEST-XSM ), 00840331269703 (VESTT28-S8PVEST-2XF ), 00840331269710 (VESTT28-S8PVEST-2XM ), 00840331269703 (VESTT28-S8PVEST-3XF ), 00840331269710 (VESTT28-S8PVEST-3XM ), 00840331269703 (VESTT28-S8PVEST-4XF ), 00840331269710 (VESTT28-S8PVEST-4XM ), 00840331269703 (VESTT28-S8PVEST-5XF ), 00840331269710 (VESTT28-S8PVEST-5XM ), 00840331269703 (VESTT38-S8PVEST-6XF ), 00840331269710 (VESTT38-S8PVEST-6XM ), 00840331269703 (VESTT38-S8PVEST-7XF ), 00840331269710 (VESTT38-S8PVEST-7XM ), 00840331269703 (VESTT38-S8PVEST-8XF ), 00840331269710 (VESTT38-S8PVEST-8XM ). 10. Model Number: S8QVEST; UDI-DI (Product Code): 00840331263794 (QVESTC18-S8QVEST-LF ), 00840331263800 (QVESTC18-S8QVEST-MF ), 00840331263817 (QVESTC18-S8QVEST-PLUS ), 00840331263824 (QVESTC18-S8QVEST-SF ), 00840331263831 (QVESTC18-S8QVEST-XLF ), 00840331269819 (QVESTT18-S8QVEST-LF ), 00840331269819 (QVESTT18-S8QVEST-MF ), 00840331269819 (QVESTT18-S8QVEST-PLUS ), 00840331269819 (QVESTT18-S8QVEST-XLF ), 00840331269819 (QVESTT28-S8QVEST-2XF ), 00840331269819 (QVESTT28-S8QVEST-3XF ), 00840331269819 (QVESTT28-S8QVEST-4XF ), 00840331269819 (QVESTT28-S8QVEST-5XF ), 00840331269819 (QVESTT38-S8QVEST-6XF ), 00840331269819 (QVESTT38-S8QVEST-7XF ). 11. Model Number: S8VEST; UDI-DI (Product Code): 00840331265477 (VESTC18-S8VEST-2XF ), 00840331265484 (VESTC18-S8VEST-2XM ), 00840331265491 (VESTC18-S8VEST-3XF ), 00840331265514 (VESTC8-S8VEST-LF ), 00840331265521 (VESTC8-S8VEST-LM ), 00840331265538 (VESTC8-S8VEST-MF ), 00840331265545 (VESTC8-S8VEST-MM ), 00840331265552 (VESTC8-S8VEST-PLUS ), 00840331265569 (VESTC8-S8VEST-SF ), 00840331265576 (VESTC8-S8VEST-SM ), 00840331265583 (VESTC8-S8VEST-XLF ), 00840331265590 (VESTC8-S8VEST-XLM ), 00840331265606 (VESTC8-S8VEST-XSF ), 00840331265613 (VESTC8-S8VEST-XSM ), 00840331265514 (VESTS8-S8VEST-LF ), 00840331265521 (VESTS8-S8VEST-LM ), 00840331265538 (VESTS8-S8VEST-MF ), 00840331265545 (VESTS8-S8VEST-MM ), 00840331265569 (VESTS8-S8VEST-SF ), 00840331265576 (VESTS8-S8VEST-SM ), 00840331265583 (VESTS8-S8VEST-XLF ), 00840331265590 (VESTS8-S8VEST-XLM ), 00840331269642 (VESTT18-S8VEST-LF ), 00840331269659 (VESTT18-S8VEST-LM ), 00840331269642 (VESTT18-S8VEST-MF ), 00840331269659 (VESTT18-S8VEST-MM ), 00840331269642 (VESTT18-S8VEST-PLUS ), 00840331269642 (VESTT18-S8VEST-SF ), 00840331269659 (VESTT18-S8VEST-SM ), 00840331269642 (VESTT18-S8VEST-XLF ), 00840331269659 (VESTT18-S8VEST-XLM ), 00840331269642 (VESTT18-S8VEST-XSF ), 00840331269659 (VESTT18-S8VEST-XSM ), 00840331269642 (VESTT28-S8VEST-2XF ), 00840331269659 (VESTT28-S8VEST-2XM ), 00840331269642 (VESTT28-S8VEST-3XF ), 00840331269659 (VESTT28-S8VEST-3XM ), 00840331269642 (VESTT28-S8VEST-4XF ), 00840331269659 (VESTT28-S8VEST-4XM ), 00840331269642 (VESTT28-S8VEST-5XF ), 00840331269659 (VESTT28-S8VEST-5XM ), 00840331269642 (VESTT38-S8VEST-6XF ), 00840331269659 (VESTT38-S8VEST-6XM ), 00840331269642 (VESTT38-S8VEST-7XF ), 00840331269659 (VESTT38-S8VEST-7XM ), 00840331269642 (VESTT38-S8VEST-8XF ), 00840331269659 (VESTT38-S8VEST-8XM ), None (IVESTC8-S8VEST-SMS ), None (IVESTC8-S8VEST-LMR ), None (IVESTC8-S8VEST-MMR ). 12. Model Number: S8ZVEST; UDI-DI (Product Code): 00840331265781 (ZVESTC18-S8ZVEST-LM ), 00840331265804 (ZVESTC18-S8ZVEST-MM ), 00840331269864 (ZVESTT18-S8ZVEST-LF ), 00840331269864 (ZVESTT18-S8ZVEST-PLUS ). 13. Model Number: U8FVEST; UDI-DI (Product Code): 00840331267044 (VESTC8-U8FVEST-LF ), 00840331267051 (VESTC8-U8FVEST-LM ), 00840331267075 (VESTC8-U8FVEST-MM ), 00840331267099 (VESTC8-U8FVEST-SF ), 00840331267105 (VESTC8-U8FVEST-SM ), 00840331267112 (VESTC8-U8FVEST-XLF ), 00840331267136 (VESTC8-U8FVEST-XSF ), 00840331269796 (VESTT18-U8FVEST-LM ), 00840331269789 (VESTT18-U8FVEST-PLUS ), 00840331269789 (VESTT18-U8FVEST-XLF ), 00840331269796 (VESTT28-U8FVEST-2XM ), 00840331269789 (VESTT28-U8FVEST-3XF ), 00840331269796 (VESTT28-U8FVEST-3XM ), 00840331269789 (VESTT38-U8FVEST-6XF ), None (IVESTC8-U8FVEST-LML ), None (IVESTC8-U8FVEST-LMR ), None (IVESTC8-U8FVEST-MFR ), None (IVESTC8-U8FVEST-MMR ), None (IVESTC8-U8FVEST-SFR ), None (IVESTC8-U8FVEST-XLML ), None (IVESTC8-U8FVEST-XLMR ). 14. Model Number: U8PVEST; UDI-DI (Product Code): 00840331267013 (VESTC18-U8PVEST-2XM ), 00840331267365 (VESTC8-U8PVEST-LF ), 00840331267372 (VESTC8-U8PVEST-LM ), 00840331267389 (VESTC8-U8PVEST-MF ), 00840331267396 (VESTC8-U8PVEST-MM ), 00840331267402 (VESTC8-U8PVEST-PLUS ), 00840331267419 (VESTC8-U8PVEST-SF ), 00840331267433 (VESTC8-U8PVEST-XLF ), 00840331267440 (VESTC8-U8PVEST-XLM ), 00840331267464 (VESTC8-U8PVEST-XSM ), 00840331269727 (VESTT18-U8PVEST-LF ), 00840331269734 (VESTT18-U8PVEST-LM ), 00840331269727 (VESTT18-U8PVEST-MF ), 00840331269734 (VESTT18-U8PVEST-MM ), 00840331269727 (VESTT18-U8PVEST-PLUS ), 00840331269727 (VESTT18-U8PVEST-SF ), 00840331269734 (VESTT18-U8PVEST-SM ), 00840331269727 (VESTT18-U8PVEST-XLF ), 00840331269734 (VESTT18-U8PVEST-XLM ), 00840331269734 (VESTT18-U8PVEST-XSM ), 00840331269727 (VESTT28-U8PVEST-2XF ), 00840331269734 (VESTT28-U8PVEST-2XM ), 00840331269727 (VESTT28-U8PVEST-3XF ), 00840331269734 (VESTT28-U8PVEST-3XM ), 00840331269734 (VESTT28-U8PVEST-4XF ), 00840331269727 (VESTT28-U8PVEST-4XF ), 00840331269734 (VESTT28-U8PVEST-4XM ), 00840331269727 (VESTT28-U8PVEST-5XF ), 00840331269734 (VESTT28-U8PVEST-5XM ), 00840331269727 (VESTT38-U8PVEST-6XF ), None (IVESTC8-U8PVEST-2XMR ), None (IVESTC8-U8PVEST-LMR ), None (IVESTC8-U8PVEST-MFR ), None (IVESTC8-U8PVEST-MMR ), None (IVESTC8-U8PVEST-SFR ), None (IVESTC8-U8PVEST-SMR ). 15. Model Number: U8QVEST; UDI-DI (Product Code): 00840331267556 (QVESTC18-U8QVEST-LF ), 00840331267563 (QVESTC18-U8QVEST-MF ), 00840331267594 (QVESTC18-U8QVEST-XLF ), 00840331267525 (QVESTC28-U8QVEST-3XF ), 00840331269826 (QVESTT18-U8QVEST-LF ), 00840331269826 (QVESTT18-U8QVEST-PLUS ), 00840331269826 (QVESTT28-U8QVEST-3XF ), 00840331296136 (QVESTT38-U8QVEST-8XF ), None (IQVESTC8-U8QVEST-LFR ). 16. Model Number: U8VEST; UDI-DI (Product Code): 00840331269215 (VESTC18-U8VEST-2XF ), 00840331269222 (VESTC18-U8VEST-2XM ), 00840331269253 (VESTC8-U8VEST-LF ), 00840331269260 (VESTC8-U8VEST-LM ), 00840331269277 (VESTC8-U8VEST-MF ), 00840331269284 (VESTC8-U8VEST-MM ), 00840331269291 (VESTC8-U8VEST-PLUS ), 00840331269307 (VESTC8-U8VEST-SF ), 00840331269314 (VESTC8-U8VEST-SM ), 00840331269321 (VESTC8-U8VEST-XLF ), 00840331269338 (VESTC8-U8VEST-XLM ), 00840331269352 (VESTC8-U8VEST-XSM ), 00840331269260 (VESTS8-U8VEST-LM ), 00840331269277 (VESTS8-U8VEST-MF ), 00840331269666 (VESTT18-U8VEST-LF ), 00840331269673 (VESTT18-U8VEST-LM ), 00840331269666 (VESTT18-U8VEST-MF ), 00840331269673 (VESTT18-U8VEST-MM ), 00840331269666 (VESTT18-U8VEST-PLUS ), 00840331269666 (VESTT18-U8VEST-SF ), 00840331269673 (VESTT18-U8VEST-SM ), 00840331269666 (VESTT18-U8VEST-XLF ), 00840331269673 (VESTT18-U8VEST-XLM ), 00840331269673 (VESTT18-U8VEST-XSM ), 00840331269666 (VESTT28-U8VEST-2XF ), 00840331269673 (VESTT28-U8VEST-2XM ), 00840331269666 (VESTT28-U8VEST-3XF ), 00840331269673 (VESTT28-U8VEST-3XM ), 00840331269666 (VESTT28-U8VEST-4XF ), 00840331269673 (VESTT28-U8VEST-4XM ), 00840331269666 (VESTT28-U8VEST-5XF ), 00840331269673 (VESTT28-U8VEST-5XM ), 00840331269666 (VESTT38-U8VEST-6XF ), 00840331269673 (VESTT38-U8VEST-6XM ), 00840331269666 (VESTT38-U8VEST-7XF ), 00840331269666 (VESTT38-U8VEST-7XM ), 00840331269666 (VESTT38-U8VEST-8XF ), 00840331269673 (VESTT38-U8VEST-8XM ), None (IVESTC8-U8VEST-2XMR ), None (IVESTC8-U8VEST-LMR ), None (IVESTC8-U8VEST-MMR ), None (IVESTC8-U8VEST-SFR ), None (IVESTC8-U8VEST-SMR ), None (IVESTC8-U8VEST-XLMR ), None (IVESTC8-U8VEST-XSFR ). 17. Model Number: U8ZVEST; UDI-DI (Product Code): 00840331269536 (ZVESTC18-U8ZVEST-MF ), 00840331269543 (ZVESTC18-U8ZVEST-MM ), 00840331269901 (ZVESTT28-U8ZVEST-5XM ).
Apr 8, 2026
View details →Oxoid australia pty limited
High PriorityActive
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
UDI/DI 5032384127498, Lot Number 4494873
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Half Aprons.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8HALF1B; UDI-DI (Product Code): 00840331272291 (HALF18-R8HALF1B). 2. Model Number: R8HALF1H; UDI-DI (Product Code): 00840331272314 (HALF18-R8HALF1H). 3. Model Number: R8HALF2B; UDI-DI (Product Code): 00840331272338 (HALF28-R8HALF2B). 4. Model Number: R8HALF2H; UDI-DI (Product Code): 00840331272345 (HALF28-R8HALF2H). 5. Model Number: R8HALF3B; UDI-DI (Product Code): 00840331272352 (HALF38-R8HALF3B). 6. Model Number: R8HALF3H; UDI-DI (Product Code): 00840331272369 (HALF38-R8HALF3H). 7. Model Number: R8HALF4B; UDI-DI (Product Code): 00840331272376 (HALF48-R8HALF4B). 8. Model Number: R8HALF4H; UDI-DI (Product Code): 00840331272383 (HALF48-R8HALF4H). 9. Model Number: R8HALF5B; UDI-DI (Product Code): 00840331272390 (HALF58-R8HALF5B). 10. Model Number: R8HALF5H; UDI-DI (Product Code): 00840331272406 (HALF58-R8HALF5H). 11. Model Number: R8HALF6B; UDI-DI (Product Code): 00840331272420 (HALF68-R8HALF6B). 12. Model Number: R8HALF6H; UDI-DI (Product Code): 00840331272352 (HALF68-R8HALF6H). 13. Model Number: R8HALFSETB; UDI-DI (Product Code): 00840331272413 (HALFSET8-R8HALFSETB). 14. Model Number: R8HALFSETH; UDI-DI (Product Code): 00840331272420 (HALFSET8-R8HALFSETH). 15. Model Number: S8HALF1H; UDI-DI (Product Code): 00840331272451 (HALF18-S8HALF1H). 16. Model Number: S8HALF2B; UDI-DI (Product Code): 00840331272475 (HALF28-S8HALF2B). 17. Model Number: S8HALF2H; UDI-DI (Product Code): 00840331272482 (HALF28-S8HALF2H). 18. Model Number: S8HALF3B; UDI-DI (Product Code): 00840331272499 (HALF38-S8HALF3B). 19. Model Number: S8HALF3H; UDI-DI (Product Code): 00840331272505 (HALF38-S8HALF3H). 20. Model Number: S8HALF4B; UDI-DI (Product Code): 00840331272512 (HALF48-S8HALF4B). 21. Model Number: S8HALF4H; UDI-DI (Product Code): 00840331272529 (HALF48-S8HALF4H). 22. Model Number: S8HALF5B; UDI-DI (Product Code): 00840331272536 (HALF58-S8HALF5B). 23. Model Number: S8HALF5H; UDI-DI (Product Code): 00840331272543 (HALF58-S8HALF5H). 24. Model Number: S8HALF6H; UDI-DI (Product Code): 00840331272499 (HALF68-S8HALF6H). 25. Model Number: S8HALFSETH; UDI-DI (Product Code): 00840331272567 (HALFSET8-S8HALFSETH). 26. Model Number: U8HALF3B; UDI-DI (Product Code): 00840331272635 (HALF38-U8HALF3B). 27. Model Number: U8HALF3H; UDI-DI (Product Code): 00840331272642 (HALF38-U8HALF3H). 28. Model Number: U8HALF4H; UDI-DI (Product Code): 00840331272666 (HALF48-U8HALF4H). 29. Model Number: U8HALF5H; UDI-DI (Product Code): 00840331272680 (HALF58-U8HALF5H). 30. Model Number: U8HALF6H; UDI-DI (Product Code): 00840331272635 (HALF68-U8HALF6H).
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 5 M12; System Code: (1)722227, (2)722231;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722227; UDI: 00884838099227; System Serial Number: 265, 135, 88, 276, 264, 271, 63, 238, 360, 23, 127, 159, 197, 149, 54, 56, 230, 192, 156, 250, 98, 31, 128, 81, 24, 37, 320, 179, 270, 151, 53, 246, 245, 84, 38, 28, 29, 170, 30, 338, 324, 108, 305, 168, 172, 356, 346, 62, 236, 25, 313, 339, 104, 321, 59, 109, 101, 19, 155, 99, 285, 247, 261, 298, 177, 138, 337, 157, 158, 228, 249, 61, 287, 55, 239, 306, 215, 336, 213, 76, 216, 73, 318, 353, 65, 167, 41, 85, 191, 20, 226, 102, 40, 87, 163, 83, 251, 268, 309, 310, 316, 290, 272, 5, 6, 7, 218, 36, 75, 195, 43, 345, 116, 18, 153, 351, 352, 14, 15, 120, 262, 204, 258, 326, 348, 17, 141, 114, 103, 355, 113, 110, 315, 21, 161, 194, 105, 173, 174, 64, 49, 71, 91, 187, 166, 210, 219, 222, 273, 205, 280, 300, 256, 335, 121, 80, 123, 243, 344, 308, 22, 140, 90, 142, 69, 200, 72, 362, 242, 323, 331, 136, 269, 137, 77, 89, 294, 181, 234, 95, 2, 111, 221, 293, 165, 342, 1, 12, 16, 257, 330, 67, 340, 260, 148, 281, 284, 248, 333, 199, 183, 106, 253, 145, 164, 241, 52, 26, 233, 301, 211, 154, 217, 332, 334, 44, 198, 297, 206, 292, 130, 58, 203, 47, 48, 107, 93, 125, 240, 122, 118, 112, 46, 176, 92, 252, 184, 57, 202, 100, 115, 133, 350, 263, 3, 32, 175, 229, 304, 124, 307, 220, 79, 60, 311, 146, 147, 319, 188, 74, 8, 9, 94, 134, 82, 143, 86, 286, 96, 227, 231, 329, 126, 162, 299, 35, 11, 259, 180, 160, 196, 322, 208, 282, 13, 178, 4, 132, 131, 209, (2) System Code: 722231; UDI: 00884838099258; System Serial Number: 13, 52, 49, 50, 41, 68, 21, 53, 67, 47, 3, 17, 18, 25, 72, 87, 93, 94, 34, 69, 61, 26, 80, 6, 7, 8, 4, 5, 60, 12, 63, 73, 14, 48, 56, 28, 66, 75, 81, 45, 20, 19, 51, 29, 27, 11, 35, 62, 54, 33, 92, 1, 2, 32, 59;
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
Paradigm Insulin Pump (MMT-712, MMT-715)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Insulin Pump: 643169999770, 643169729360, 763000065201, 763000069001, 763000192228, 763000198602, 763000155346, 763000192143, 763000258344, 763000317140, 763000404567, 763000317188, 763000317195, 763000367046, 763000317157, 00613994470492, 00643169496262, 643169577664, 643169577688, 643169577695, 643169739512, 00613994332929, 00613994469694, 00613994470904, 00763000084271, 00763000161019, 643169577701, 643169739512, 643169662612, 00643169533776, 00763000084370, 643169656840, 763000090197, 763000190439, 763000316631, 00613994473820, 00643169478503, 00613994151766, 00643169710368, 00763000161057, 00613994326478, 00613994326508, 00613994395771, 00613994395719, 00613994395696, 00613994527851, 00643169729421, 00643169198920, 00643169572447, 00643169198890, 00613994527868, 00613994172129, 00613994172419, 00613994171627, 00613994171344, 00613994172211, 00613994172525, 00613994172334, 00613994172044, 00613994172761, 00613994171917, 00613994326621, 00613994326584, 00643169848825, 00643169848832, 00643169848801, 00613994395818, 00613994395764, 00613994395740, 00613994394132, 00763000069209, 00763000069179, 00613994527905, 00763000069162, 00613994527769, 00613994405876, 00763000069186, 00763000069148, 00613994527783, 00613994527806, 00613994527899, 00613994527790, 00613994527882, 00613994527837, 00643169198968, 00643169198883, 00643169198944, 00643169198906, 00763000084301, 00613994527745, 00643169198975, 00643169035515, 00643169201927, 00643169198913, 00643169198937, 00613994475268, 00643169198999, 00643169198982, 00643169503120, 00763000187507, 00643169198951, 00643169848818, 00643169848795, 00643169848771, 00613994527738, 00613994171443, 00613994171528, 00613994326539, 00613994326560, 00613994395726, 00613994395757, 00763000102616, 00763000069155, 00613994473868, 00763000004262, 00763000084318, 00763000161064, 76300031665503, 763000316655, 643169656840, 763000367053, 763000090197, 763000166519, 763000072520, 763000190439, 76300031665501, 763000316631, 763000256807: INSTR,US,FINE TUNING,PUMP,512/712 (6024948-012 3); INSTR,US,FINE TUNING,PUMP,PRDGM (6024948-013 1); INSTR,EN,FINE TUNING,PUMP (6024948-021 3); INSTR,US,PUMPS,PRDGM,515/715 (6025020-017 1); INSTR., 515/715, PRDGM, US (6025020-018 2); INSTR, 515/715, MDD, EN (6025020-024 1); INSTR, 515/715, EURO-E, MDD (6025020-025 2); INSTR., X15, EN OUS (6025020-026 1)
Apr 8, 2026
View details →Civco medical instruments co. inc.
High PriorityActive
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
Airway Exam Kit, DYKE1796
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
UDI-DI 10193489874716 (ea) 40193489874717 (case) Lots 24CBT023 24FBB701 24LBL343 25GBP141
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722063; UDI: 00884838085275; System Serial Number:122, 56, 64, 131, 84, 132, 96, 98, 108, 77, 82, 145, 47, 146, 80, 102, 43, 117, 2, 149, 99, 44, 3, 28, 144, 62, 119, 61, 22, 29, 153, 40, 70, 30, 25, 19, 120, 121, 110, 14, 16, 17, 53, 103, 127, 97, 143, 41, 104, 116, 151, 93, 141, 115, 137, 73, 150, 128, 105, 4, 50, 129, 72, 38, 21, 78, 23, 76, 63, 69, 59, 51, 92, 139, 130, 154, 75, 24, 94, 100, 54, 46, 26, 71, 106, 83, 36, 37, 27, 15, 135, 123, 107, 87, 85, 89, 88, 86, 90, 91, 79, 133, 81, 140, 52, 48, 148, 55, 113; (2) System Code: 722221; UDI: 00884838085275; System Serial Number:181, 3, 7, 178, 54, 6, 93, 69, 9, 115, 177, 85, 19, 49, 171, 153, 108, 193, 104, 169, 45, 101, 135, 106, 51, 114, 36, 124, 197, 129, 4, 154, 146, 68, 195, 130, 183, 187, 42, 172, 164, 190, 151, 71, 152, 184, 147, 32, 105, 182, 58, 103, 149, 127, 128, 86, 122, 60, 155, 66, 33, 55, 70, 123, 118, 61, 44, 185, 74, 95, 205, 13, 99, 34, 142, 39, 144, 82, 145, 59, 77, 180, 126, 97, 132, 79, 91, 161, 102, 52, 120, 162, 64, 75, 41, 84, 131, 94, 96, 38, 48, 31, 92, 78, 186, 133, 167, 23, 26, 40, 10, 203, 30, 207, 208, 76, 50, 98, 107, 158, 157, 62, 29, 194, 73, 25, 15, 119, 140, 166, 57, 27, 2, 47, 16, 141, 143, 35, 168, 83, 163, 202, 67, 198, 134, 5, 81, 22, 28, 165, 196, 173, 46, 53, 8, 56, 174, 43, 159, 1, 176, 11; (3) System Code: 722229; UDI: 00884838085275; System Serial Number: 22, 9, 40, 7, 24, 35, 16, 15, 41, 5, 3, 29, 4, 38, 33, 32, 6, 2, 20, 26, 31, 10, 11, 21, 25, 13, 8;
Apr 8, 2026
View details →Civco medical instruments co. inc.
High PriorityActive
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
UDI-DI: 00841436111089; Lot Number: A276633
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722068; UDI: 00884838085367; System Serial Number: 547, 178, 467, 335, 147, 205, 170, 455, 494, 564, 418, 95, 440, 247, 225, 64, 149, 42, 153, 324, 323, 320, 85, 89, 109, 407, 239, 505, 271, 443, 104, 370, 322, 136, 373, 442, 524, 308, 354, 75, 279, 400, 196, 510, 110, 446, 78, 330, 73, 288, 285, 295, 406, 528, 329, 184, 350, 462, 304, 457, 470, 472, 319, 520, 490, 243, 103, 479, 261, 262, 150, 277, 172, 117, 130, 356, 143, 146, 84, 251, 469, 431, 361, 76, 374, 270, 114, 511, 477, 232, 137, 282, 487, 413, 337, 101, 213, 82, 265, 275, 485, 459, 276, 62, 506, 608, 473, 417, 302, 314, 88, 126, 211, 468, 422, 454, 410, 283, 231, 548, 466, 495, 207, 167, 445, 537, 438, 173, 233, 289, 536, 192, 204, 77, 166, 313, 236, 133, 481, 280, 307, 577, 210, 258, 328, 325, 199, 480, 53, 72, 364, 491, 423, 509, 246, 614, 142, 376, 539, 257, 140, 369, 195, 500, 508, 97, 87, 303, 48, 44, 301, 550, 460, 118, 293, 551, 478, 522, 568, 448, 242, 238, 68, 160, 83, 544, 230, 434, 435, 360, 93, 36, 372, 179, 306, 182, 583, 327, 244, 382, 428, 432, 215, 447, 338, 399, 339, 316, 555, 552, 570, 347, 148, 134, 38, 560, 158, 535, 318, 518, 250, 336, 185, 206, 50, 489, 521, 37, 79, 529, 111, 254, 427, 394, 71, 47, 534, 292, 497, 591, 35, 227, 359, 527, 387, 168, 128, 129, 396, 515, 486, 543, 69, 453, 174, 483, 484, 334, 425, 181, 408, 415, 141, 365, 471, 540, 584, 553, 602, 240, 617, 604, 593, 589, 526, 559, 612, 450, 556, 557, 574, 603, 601, 609, 616, 597, 605, 575, 516, 624, 599, 563, 590, 198, 600, 228, 380, 420, 397, 212, 475, 180, 268, 269, 414, 74, 562, 115, 349, 291, 519, 234, 219, 532, 533, 60, 398, 618, 549, 46, 96, 416, 249, 531, 426, 162, 290, 346, 49, 326, 286, 125, 102, 113, 124, 138, 362, 127, 145, 299, 317, 571, 187, 183, 45, 331, 106, 465, 281, 112, 501, 393, 116, 273, 188, 264, 139, 503, 122, 439, 135, 248, 404, 390, 263, 90, 300, 224, 67, 61, 157, 154, 100, 217, 253, 391, 144, 379, 202, 105, 226, 315, 464, 197, 63, 252, 175, 274, 163, 186, 260, 502, 152, 498, 156, 621, 296, 208, 430, 161, 436, 409, 155, 298, 191, 278, 368, 94, 66, 108, 200, 201, 98, 189, 311, 367, 297, 132, 507, 451; (2) System Code: 722226; UDI: 00884838099272; System Serial Number: 120, 122, 123, 124, 125, 126, 127, 153, 67, 209, 271, 675, 112, 1052, 1091, 113, 121, 139, 158, 1078, 1145, 239, 105, 678, 114, 362, 758, 403, 702, 108, 545, 197, 380, 281, 688, 592, 593, 495, 319, 687, 921, 182, 183, 325, 690, 100, 272, 680, 724, 350, 891, 280, 270, 254, 107, 144, 761, 681, 691, 779, 294, 845, 559, 116, 343, 98, 301, 117, 876, 1021, 244, 332, 781, 782, 534, 341, 374, 78, 11, 441, 129, 180, 918, 442, 220, 555, 189, 190, 871, 446, 842, 255, 848, 208, 554, 955, 360, 337, 159, 400, 757, 326, 323, 175, 427, 464, 468, 778, 683, 143, 262, 482, 971, 391, 392, 173, 793, 147, 204, 467, 1017, 260, 381, 912, 410, 508, 419, 313, 472, 894, 318, 473, 383, 689, 973, 463, 823, 181, 205, 361, 59, 756, 379, 1008, 266, 1002, 398, 75, 786, 19, 1125, 213, 214, 215, 1007, 814, 969, 970, 469, 219, 462, 296, 149, 704, 573, 458, 987, 141, 711, 693, 510, 882, 226, 509, 584, 21, 1050, 647, 225, 201, 202, 303, 666, 184, 243, 178, 179, 250, 1139, 674, 1062, 575, 1121, 368, 950, 861, 176, 712, 829, 413, 997, 249, 589, 1046, 708, 738, 1083, 717, 697, 1126, 665, 416, 386, 764, 977, 595, 859, 1113, 721, 1043, 797, 957, 1006, 498, 60, 232, 423, 682, 789, 698, 331, 1097, 1094, 378, 808, 1107, 393, 949, 718, 663, 195, 411, 1092, 412, 715, 1143, 775, 1073, 982, 282, 785, 617, 958, 221, 222, 604, 430, 1027, 1067, 415, 810, 1114, 61, 1147, 314, 822, 561, 1026, 1102, 762, 306, 359, 978, 1060, 972, 83, 199, 1013, 920, 1136, 898, 835, 836, 795, 671, 799, 800, 899, 905, 838, 944, 1123, 335, 363, 1039, 731, 399, 869, 725, 701, 626, 967, 623, 744, 501, 953, 1018, 513, 533, 677, 449, 119, 367, 927, 480, 732, 974, 344, 824, 984, 487, 919, 605, 230, 523, 686, 327, 1138, 424, 684, 477, 1049, 298, 809, 10, 227, 520, 521, 522, 993, 874, 259, 140, 628, 530, 506, 909, 142, 733, 263, 490, 494, 633, 634, 396, 547, 631, 514, 642, 505, 321, 754, 17, 422, 1057, 420, 247, 99, 36, 432, 539, 88, 245, 911, 132, 133, 667, 5, 1103, 188, 586, 14, 622, 228, 4, 1069, 45, 316, 164, 485, 448, 507, 97, 351, 497, 685, 771, 790, 1076, 543, 66, 542, 550, 551, 484, 504, 714, 1054, 366, 18, 1048, 893, 1132, 217, 752, 1088, 47, 544, 148, 408, 906, 289, 548, 238, 299, 283, 284, 401, 404, 827, 833, 84, 692, 895, 118, 924, 224, 233, 1087, 579, 515, 455, 946, 599, 726, 676, 395, 670, 1, 261, 444, 826, 93, 956, 1077, 900, 901, 320, 355, 710, 435, 1072, 820, 749, 235, 846, 727, 621, 1129, 1041, 777, 1053, 274, 486, 1014, 1015, 503, 1071, 431, 481, 460, 765, 194, 696, 1099, 25, 451, 438, 275, 552, 352, 87, 630, 1047, 941, 345, 349, 429, 854, 1009, 888, 369, 557, 585, 596, 342, 457, 645, 739, 736, 1127, 963, 527, 251, 1115, 1000, 965, 553, 1042, 699, 1064, 574, 741, 748, 1137, 887, 632, 1118, 737, 1131, 1148, 1111, 907, 662, 825, 1075, 877, 1134, 1023, 648, 831, 1135, 751, 1061, 1036, 1104, 830, 1152, 860, 798, 603, 577, 938, 886, 1066, 773, 939, 1128, 1065, 1038, 716, 979, 672, 1109, 903, 549, 669, 747, 1124, 29, 817, 995, 625, 439, 297, 743, 27, 131, 643, 644, 563, 639, 640, 945, 22, 203, 333, 50, 813, 198, 168, 166, 766, 16, 580, 384, 740, 755, 1022, 207, 598, 491, 896, 54, 849, 82, 679, 330, 417, 892, 277, 278, 152, 720, 385, 641, 1020, 55, 742, 305, 832, 1059, 409, 947, 902, 867, 627, 872, 418, 489, 231, 1080, 407, 6, 1089, 913, 840, 24, 364, 307, 1035, 1055, 531, 532, 745, 1033, 791, 591, 772, 878, 86, 1093, 7, 768, 664, 85, 52, 53, 890, 63, 637, 815, 943, 729, 1079, 478, 1106, 546, 650, 26, 883, 171, 453, 889, 753, 673, 844, 276, 649, 69, 1058, 556, 528, 660, 74, 358, 855, 568, 353, 286, 317, 42, 115, 229, 285, 440, 606, 156, 908, 43, 288, 933, 161, 162, 828, 421, 818, 540, 73, 452, 405, 46, 694, 722, 583, 784, 525, 312, 570, 160, 658, 804, 216, 95, 709, 803, 39, 856, 853, 653, 502, 70, 128, 287, 40, 1032, 655, 89, 279, 851, 807, 581, 265, 237, 106, 304, 137, 110, 336, 257, 68, 841, 234, 885, 654, 64, 916, 3, 819, 192, 193, 618, 32, 292, 206, 904, 49, 541, 646, 456, 870, 258, 172, 529, 38, 866, 382, 524, 659, 33, 656, 801, 802, 290, 30, 92, 269, 240, 163, 852, 62, 1034, 436, 806, 210, 187, 264, 578, 928, 847, 90, 587, 499, 154, 273, 186, 34, 44, 65, 71, 558, 425, 196, 91, 657, 35, 356, 500, 537, 375, 567, 668, 454, 479, 31, 450, 496, 302, 80, 406, 857, 41, 770, 56, 155, 619, 177, 811, 96, 28, 560, 433, 308, 998, 324, 157, 357, 340, 588, 934, 79, 77, 476, 236, 146, 863, 165, 402, 652, 241; (3) System Code: 722236; UDI: 00884838116788; System Serial Number: 127, 37, 159, 345, 24, 17, 25, 180, 150, 227, 235, 131, 288, 226, 231, 203, 26, 20, 249, 121, 200, 208, 42, 205, 36, 183, 81, 147, 148, 133, 31, 342, 54, 194, 43, 158, 99, 21, 40, 60, 118, 50, 378, 325, 335, 39, 191, 280, 233, 48, 197, 221, 68, 204, 51, 230, 38, 22, 186, 32, 276, 116, 134, 272, 273, 330, 357, 10, 289, 67, 242, 361, 29, 192, 223, 13, 164, 368, 353, 215, 348, 244, 322, 352, 300, 114, 383, 173, 351, 117, 376, 201, 278, 414, 271, 34, 122, 123, 374, 326, 162, 93, 245, 241, 207, 232, 380, 312, 385, 377, 216, 219, 311, 56, 57, 169, 91, 167, 44, 234, 156, 324, 375, 274, 237, 113, 46, 33, 292, 66, 165, 163, 283, 284, 285, 193, 297, 287, 347, 321, 8, 269, 102, 316, 132, 157, 224, 331, 98, 168, 189, 30, 370, 146, 125, 333, 182, 405, 27, 145, 329, 100, 23, 338, 96, 181, 188, 258, 130, 358, 154, 279, 264, 126, 128, 86, 94, 379, 160, 310, 41, 170, 82, 63, 268, 328, 277, 111, 172, 112, 259, 318, 103, 75, 84, 52, 73, 80, 175, 305, 92, 155, 55, 85, 142, 105, 108, 53, 144, 198, 141, 299, 124, 320, 62, 261, 88, 89, 109, 83, 171, 317, 240, 76, 106, 90, 251, 49, 314, 77, 74, 78, 59, 206, 104, 70, 107, 64, 151, 152, 293, 69, 153;
Apr 8, 2026
View details →Bd kiestra lab automation
High PriorityActive
BD Kiestra" ReadA; Catalog No.: 446948.
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;
Apr 8, 2026
View details →Mentor texas, lp.
High PriorityActive
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
UDI(s):10081317028427 10081317028434 10081317028458 10081317028465
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 620G Insulin Pump (MMT-1750)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 620G Insulin Pump: 643169559745, 643169721319, 763000375461, 763000253189: Instr, Startup Guide, 620G 4.10, EN(6025951-022 1); INSTR., NGP 620G, BOLUS WIZARD, EN(6026006-023 1); Instr., 620G, Sftwr. 4.10, EN.(6026006-024 1); INSTRUCTIONS MMT-746EN PUMP 1510/1710 EN(7005933-023 1); DOC PKG MMT-746EN NGP 1710 EN(7005933-024 1); Startup Guide Assembly MMT-755EN(620G(M982438A021 1).
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Allura Xper FD20/15 OR Table; System Code: 722059;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
System Code: 722059; UDI: 00884838059122; System Serial Number: 33, 7, 35, 40, 38, 41, 37, 2;
Apr 8, 2026
View details →Intuitive surgical, inc.
High PriorityActive
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Lot Code: 420194, Mega Needle Driver GTIN: 00886874111611 FDA Medical Listing Number: D088920 Material Number: 420194-08 Batch / System Numbers: M10120201 SH1182 M20120412 SH1182 M10130121 SH1570 M10130306 SH1570 M10110602 SH0547 M10110627 SH0547 M10121129 SH0059 M10121214 SH0059 M10130429 SH0059 M10130521 SH0059 M10121105 SH1557 M10130517 SH1837 M10121109 SH1390 M10130508 SH1390 M10131004 SH1390 M10130306 USG689 M10130412 USG689 M10110302 SH1368 M10110614 SH1368 M10110620 SH1368 M10110817 SH1368 M10120705 SH1368 M10121022 SH1368 M10130429 SH1368 M10130509 SH1368 M10130722 SH1368 M10110131 USG294 M10110511 USG294 M10110616 USG294 M10110811 USG294 M10111003 USG294 M20111103 USG294 M10111206 USG294 M20120103 USG294 M10120130 USG294 M10120305 USG294 M10120425 USG294 M10120713 USG294 M10121004 USG294 M10121017 USG294 M10121022 USG294 M10121105 USG294 M10121107 USG294 M10121206 USG294 M10121207 USG294 M10130108 USG294 M10130112 USG294 M10130201 USG294 M10130213 USG294 M10130215 USG294 M10130529 USG294 M11130608 USG294 M10130718 USG294 M10130829 USG294 M10120321 SG2026 M10120605 SG2026 M10111114 SH0825 M10110330 SH0935 M10110401 SH0935 M10120123 SH0935 M10120313 SH0935 M10120404 SH0935 M10120802 SH0935 M10120919 SH0935 M10121121 SH0935 M10110302 SH0729 M10110503 SH0729 M10110701 SH0729 M10110809 SH0729 M10110817 SH0729 M10110825 SH0729 M10110913 SH0729 M10110923 SH0729 M10111116 SH0729 M20111123 SH0729 M10111201 SH0729 M10120120 SH0729 M10120130 SH0729 M10120210 SH0729 M10120217 SH0729 M10120301 SH0729 M10120412 SH0729 M10120507 SH0729 M10120525 SH0729 M20120530 SH0729 M10120703 SH0729 M10120724 SH0729 M10120803 SH0729 M10120810 SH0729 M10120827 SH0729 M10121025 SH0729 M10130102 SH0729 M10130212 SH0729 M10130213 SH0729 M10130314 SH0729 M10130418 SH0729 M10130517 SH0729 M10130603 SH0729 M10130606 SH0729 M10130617 SH0729 M10130701 SH0729 M10131014 SH0729 N10140430 SH0729 M10101206 SH0035 M10110624 SH0035 M10101206 SH1391 S10110307 SH1391 M10110302 SH1391 M10110701 SH1391 M10120404 SH1391 M10120705 SH1391 M10121010 SH1391 M10130118 SH1391 M10130125 SH1391 M10130515 SH1391 M10130626 SH1391 M10121206 SH1604 M10130308 SH1604 M10101127 SH0495 M10101217 SH0495 M10110131 SH0495 M10110512 SH0495 M10110817 SH0495 M10110901 SH0495 M10111008 SH0495 M20111221 SH0495 M10120217 SH0495 M10120224 SH0495 M10110527 SH0495 M10120727 SH0495 M10121004 SH0495 M10130102 SH0495 M10130213 SH0495 M10130301 SH0495 M10130812 SH0495 M10130924 SH0495 M10111201 SH1015 M10111208 SH1015 M10120217 SH1015 M10120425 SH1015 M10120618 SH1015 M10120713 SH1015 M10120823 SH1015 M10120827 SH1015 M10121022 SH1015 M10130212 SH1015 M10130213 SH1015 M10130828 SH1015 M10120831 SH1385 M10120918 SH1385 M10110412 SH2144 M10110706 SH2144 M10110923 SH2144 M10111008 SH2144 M10111205 SH2144 M20120103 SH2144 M10120210 SH2144 M10120713 SH2144 M10121121 SH2144 M10130325 SH2144 M10130529 SH2144 M10110302 SH0761 M10121129 SH0761 M10130719 SH0761 M10131001 SH0761 M20120322 SH1276 M10120525 SH1276 M10130503 USG518 M10130821 USG518 M10130828 USG518 M10131014 USG518 Material Number: 420194-10 Batch / System Numbers: N10170714 SH1182 N10170817 SH1182 N10171019 SH1182 M10140303 SH1570 N10140805 SH1570 N10150702 SH1570 N10160311 SH1570 N10160421 SH1570 N10161206 SH1570 N10161223 SH1570 N10180227 SG704 M10131121 SH0547 N10140609 SH0547 M10140221 SH0059 M10140307 SH0059 N10140508 SH0059 N10140827 SH0059 N10150320 SH0059 N10160519 SH0059 N10160728 SH0059 N11160907 SH0059 N11161013 SH0059 N10161129 SH0059 N10170419 SH0059 N11170407 SH0059 N10170612 SH0059 N10170705 SH0059 N10180202 SH0059 N10180323 SH0059 N10180321 SH0059 N10180412 SH0059 M10140225 SH1557 N10140605 SH1557 N10140620 SH1557 N10140827 SH1557 N12140929 SH1557 N10150211 SH1557 N10150320 SH1557 N10150528 SH1557 N10150616 SH1557 N10150721 SH1557 N10151209 SH1557 N10160307 SH1557 N10160519 SH1557 N10160509 SH1557 N10160728 SH1557 N10160907 SH1557 N10161031 SH1557 N11170111 SH1557 N11161216 SH1557 N11170427 SH1557 N10170504 SH1557 N10170605 SH1557 N10170914 SH1557 N10171016 SH1557 N10171027 SH1557 N10180118 SH1557 N10180223 SH1557 N10180321 SH1557 N10180427 SH1557 N10150604 SH1964 N10150626 SH1964 N10151207 SH1964 N10151211 SH1964 N10180131 SH1964 N10180223 SH1964 N10180404 SH1964 N10180426 SH1964 N10150814 SH1837 N10160105 SH1837 N10160728 SH1837 N11160901 SH1837 N10150717 SH1390 N10160419 SH1390 M10131211 USG689 N10160519 USG689 M10140515 SH1368 N11141113 SH1368 N10160105 SH1368 N10160718 SH1368 N10170901 SH1368 M10131102 USG294 M10140107 USG294 M10140109 USG294 M10140221 USG294 M10140408 USG294 N10140516 USG294 N10140923 USG294 N10141016 USG294 N10150219 USG294 N10150325 USG294 N10150723 USG294 N10151002 USG294 N10151013 USG294 N10160104 USG294 N10160307 USG294 N10160504 USG294 N11160616 USG294 N11160720 USG294 N10160907 USG294 N11160923 USG294 N10161118 USG294 N10161207 USG294 N10170302 USG294 N10170421 USG294 N10170621 USG294 N10170817 USG294 N10170927 USG294 N10180202 USG294 N10171214 USG294 N10180131 USG294 M10140324 SH2186 N10141127 SH2186 N10150320 SH2186 N10150626 SH2186 N10150731 SH2186 N10160901 SH2186 N10170427 SH2186 N10170509 SH2186 N10171221 SH2186 N10180321 SH2186 N11161207 SH0825 N10170511 SH0825 N10180301 SH0825 M10131109 SH1378 M10131104 SH0935 M10140225 SH0935 N10140718 SH0935 M10131109 SH0729 M10131130 SH0729 M10131202 SH0729 M10140107 SH0729 N10140611 SH0729 N10140716 SH0729 N10140717 SH0729 N10140728 SH0729 N10140826 SH0729 N11140929 SH0729 N10141118 SH0729 N10141205 SH0729 N10150219 SH0729 N10150226 SH0729 N10150421 SH0729 N10150428 SH0729 N10150721 SH0729 N10150804 SH0729 N10151123 SH0729 N10151203 SH0729 N10160311 SH0729 N11160419 SH0729 N11160907 SH0729 N10161019 SH0729 N10170324 SH0729 N11170410 SH0729 N10170511 SH0729 N10170621 SH0729 N10170810 SH0729 N10171207 SH0729 N10180202 SH0729 N11171214 SH0729 N11180321 SH0729 N10180307 SH0729 N10180412 SH0729 N10140722 SH0035 N10140910 SH0035 N10150519 SH0035 N10150707 SH0035 N11160711 SH0035 N10160804 SH0035 N10170207 SH0035 N10170511 SH0035 N10171207 SH0035 M10131121 SH1391 M10131217 SH1391 N10140516 SH1391 M10140206 SH2125 N10140530 SH2125 N10140611 SH2125 N10140926 SH2125 N10150105 SH2125 N10150413 SH2125 N10150504 SH2125 N10150804 SH2125 N10150918 SH2125 N10150928 SH2125 N10160114 SH2125 N10160504 SH2125 N10160519 SH2125 N10160601 SH2125 N10161019 SH2125 N10161216 SH2125 N10170404 SH2125 N10161025 SH2125 M10131104 SH2125 N10170712 SH2125 N10171103 SH2125 N11171214 SH2125 N10180223 SH2125 N10150818 SH2125 N10180323 SH2125 N10180321 SH2125 N10180427 SH2125 N10160219 SH1076 N10170427 SH1076 M10140116 SH1604 N10170926 SH1604 N10180122 SH1604 N10180111 SH1604 M10140121 SH0495 M10140303 SH0495 N10140522 SH0495 N10140808 SH0495 N11141112 SH0495 N10141127 SH0495 N11141205 SH0495 N10150226 SH0495 N10150626 SH0495 N10150811 SH0495 N10160523 SH0495 N10160822 SH0495 N11160822 SH0495 N10161118 SH0495 N10170301 SH0495 N10170927 SH0495 N10180202 SH0495 M10131119 SH1015 M11140109 SH1015 M10140131 SH1015 M10140307 SH1015 N10140425 SH1015 N10140708 SH1015 N10140904 SH1015 N11140902 SH1015 N10150204 SH1015 N10150211 SH1015 N10150216 SH1015 N10150511 SH1015 N10150610 SH1015 N10150630 SH1015 N10150707 SH1015 N10150828 SH1015 N10150916 SH1015 N10150928 SH1015 N10160212 SH1015 N10160229 SH1015 N10160307 SH1015 N10160330 SH1015 N10160504 SH1015 N10160610 SH1015 N10160616 SH1015 N10160630 SH1015 N10160706 SH1015 N11160711 SH1015 N10160822 SH1015 N11160907 SH1015 N10160901 SH1015 N11161013 SH1015 N11161118 SH1015 N10161118 SH1015 N10161223 SH1015 N10170202 SH1015 N10170302 SH1015 N10170316 SH1015 N11170324 SH1015 N10170331 SH1015 N10170504 SH1015 N10170511 SH1015 N10170515 SH1015 N10170623 SH1015 N10170710 SH1015 N10170720 SH1015 N10170901 SH1015 N10171003 SH1015 N10171103 SH1015 N10180312 SH1015 N10171221 SH1015 N10180122 SH1015 N10171226 SH1015 N10180124 SH1015 N10180227 SH1015 N10180426 SH1015 N10180412 SH1385 M10140303 SH2144 M10140326 SH2144 N10140605 SH2144 N10140805 SH2144 N10150223 SH2144 N10160519 SH2144 N10170913 SH2144 N10150312 SH0761 N10150528 SH0761 M10140206 SH1276 M10140213 SH1276 M10140327 SH1276 N10140508 SH1276 N10140925 SH1276 N10150305 SH1276 N10151021 SH1276 N10151125 SH1276 N10140902 USG518 N12140929 USG518 N10141008 USG518 M10140108 USG518 N10150320 USG518 N10161111 USG518 N10170103 USG518 Material Number: 420194-12 Batch / System Numbers: N10190729 SH1182 N10180921 SH1557 N10190104 SH1557 N10190211 SH1557 N10190326 SH1557 N12190423 SH1557 N10190719 SH1557 N11191021 SH1557 N10191216 SH1557 N10210329 SH1557 N10210524 SH1557 N10210517 SH1557 N10190108 SH1837 N10200727 SH1837 N10201012 SH1837 N10201103 SH1837 N10210412 SH1837 N10191111 USG689 N10191125 USG689 N10190805 SH1368 N10190930 SH1368 N10180808 USG294 N10180906 SH2186 N10190522 SH2186 N10201012 SH2186 N10190226 SH0825 N10190326 SH0825 N10210412 SH0825 N10181126 SH0729 N10190107 SH0729 N10190212 SH0729 N10180814 SH2125 N10180815 SH2125 N10181008 SH2125 N10190107 SH2125 N10190212 SH2125 N10190327 SH2125 N10190729 SH2125 N10191111 SH1076 N10180808 SH1604 N10190930 SH1604 N10190108 SH0495 N10190805 SH0495 N10190930 SH0495 N10200727 SH0495 N10180814 SH1015 N10180813 SH1015 N10181017 SH1015 N10190107 SH1015 N10190108 SH1015 N10190307 SH1015 N10190308 SH1015 N10190522 SH1015 N10190805 SH1015 N10190923 SH1015 N10190917 SH1015 N10191111 SH1015 N11191202 SH1015 N10191216 SH1015 N10191125 SH1015 N10191021 SH1015 N10200810 SH1015 N10201103 SH1015 N10210802 SH1015 N10181024 SH1385 N10191111 SH1385 N10190107 SH1279 N10190212 SH1279 N10190327 SH1279 N10210607 SH1279 Material Number: 420194-13 Batch / System Numbers: K11220626 SH1964 K10220228 SH1837
Apr 8, 2026
View details →Synthes (usa) products llc
High PriorityActive
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.
Apr 8, 2026
View details →Civco medical instruments co. inc.
High PriorityActive
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
UDI-DI: 00841436111102; Lot Number: A257459, A252198, A268105, A276632
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Leg Wraps.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8LGW1; UDI-DI (Product Code): 00840331272079 (LGW8SET-R8LGW1). 2. Model Number: R8LGW2; UDI-DI (Product Code): 00840331272086 (LGW8SET-R8LGW2). 3. Model Number: R8LGW3; UDI-DI (Product Code): 00840331272055 (LGW8SET-R8LGW3). 4. Model Number: S8LGW1; UDI-DI (Product Code): 00840331272116 (LGW8SET-S8LGW1). 5. Model Number: S8LGW2; UDI-DI (Product Code): 00840331272123 (LGW8SET-S8LGW2). 6. Model Number: S8LGW3; UDI-DI (Product Code): 00840331272093 (LGW8SET-S8LGW3). 7. Model Number: S8LGW4; UDI-DI (Product Code): 00840331272109 (LGW8SET-S8LGW4). 8. Model Number: U8LGW1; UDI-DI (Product Code): 00840331272154 (LGW8SET-U8LGW1). 9. Model Number: U8LGW2; UDI-DI (Product Code): 00840331272161 (LGW8SET-U8LGW2). 10. Model Number: U8LGW4; UDI-DI (Product Code): 00840331272147 (LGW8SET-U8LGW4).
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Veo: 00613994717801, 00613994713834, 00613994713841, 00613994870414, 00613994870377, 00613994870407, 00643169378636, 00613994924957, 00613994717672, 00613994715531, 00613994715555, 00613994715562, 00613994409423, 00613994951502, 00643169026131, 00613994622600, 00613994407740, 00643169077737, 00643169464537, 00643169305038, 00643169500259, 00643169503229, 00643169528789, 00643169533776, 00613994151766, 00643169711440, 00763000084370, 00763000161224, 00763000161262, 00643169464520, 00613994963376, 00643169026100, 00613994924247, 00643169299757, 00643169400931, 00643169400986, 00643169535749, 00643169535794, 00643169519190, 00643169579507, 00643169519091, 00763000084349, 00763000084356, 00763000161248, 00763000048853, 00763000161231, 00643169729445, 00643169846036, 00643169579453, 00613994714183, 00613994716156, 00613994657671, 00643169515741, 00643169579514, 00643169579538, 00643169579477, 00643169579569, 00643169579392, 00643169579583, 00643169579552, 00643169579576, 00643169846012, 00643169845909, 00643169845947, 00643169845992, 00643169846043, 00763000067663, 00643169846005, 00763000001247, 00643169578470, 00763000059729, 00763000048860,00763000048914, 00763000048839, 00763000048884, 00763000048822, 00763000048808, 00763000048938, 00763000048815, 00763000048921, 00763000048891, 00763000048785, 00763000048945, 00763000048877, 00763000048846, 00613994924438, 00613994924223, 00613994924391, 00613994924339, 00613994924346, 00613994924216, 00613994924278, 00763000084387, 00643169196766, 00613994611697, 00613994715944, 00613994714190, 00613994716002, 00613994716248, 00613994717719, 00613994716194, 00613994716361, 00613994716422, 00613994716415, 00613994716200, 00613994716354, 00613994716187, 00613994716323, 00613994716408, 00613994716385, 00613994716378, 00613994716217, 00613994863560, 00613994863515, 00613994863607, 00613994863409, 00613994863614, 00613994863355, 00613994863393, 00613994863430, 00613994863416, 00613994863553, 00613994863577, 00613994863539, 00613994863584, 00613994974273, 00613994870278, 00613994863621, 00613994924032, 00613994924254, 00613994863638, 00613994924353, 00613994924414, 00613994924445, 00613994863522, 00613994924407, 00613994863546, 00613994924384, 00613994924230, 00613994924421, 00613994750969, 00643169196674, 00643169196612, 00643169196704, 00643169196735, 00643169196698, 00643169196711, 00643169196773, 00643169196681, 00643169196728, 00643169196759, 00643169196742, 00643169196780, 00643169196636, 00643169196650, 00643169341654, 00643169317550, 00643169317574, 00643169317611, 00643169317567, 00643169317659, 00643169317642, 00643169317666, 00643169317536, 00643169306912, 00643169317581, 00643169341647, 00643169341661, 00643169324039, 00643169318960, 00643169317604, 00643169317598, 00643169317628, 00643169341630, 00643169324084, 00643169326668, 00643169317635, 00643169319370, 00643169381827, 00643169378995, 00643169379008, 00643169381810, 00643169378988, 00643169381780, 00643169381834, 00643169381773, 00643169381889, 00643169381872, 00643169381803, 00643169381797, 00643169381896, 00643169381766, 00643169381841, 00643169381902, 00643169428232, 00643169383838, 00643169379572, 00643169378704, 00643169411692, 00643169382725, 00643169495593, 00643169381865, 00763000084363, 00643169376090, 00643169579545, 00643169579521, 00643169593404, 00643169579439, 00643169579415, 00643169579484, 00643169579491, 00643169742048, 00643169579408, 00643169579422, 00643169845985, 00763000161279, 00763000217396, 00643169845954, 00643169845930, 00643169846067, 00643169846050, 00643169845961, 00643169846029, 00763000161255, 00643169845923, 00763000048907, 00763000048792: Labeling/Packaging; INSTR, INSULIN PUMP 554/754 (6025362 1) INSTRUCTIONS FOR USE, 554/754, DE (6025362-071 4); INSTR,INSULIN PUMP, 554/754 (6025362-022 7); INSTR,INSULIN PUMP, 554/754 (6025362-021 2); INSTR, 554/754, EN, A52 (6025362-024 1); INSTR. FOR USE, 554/754, EN (6025362-023 2); INSTR., INSULIN PUMP, 554/754 (6025362-026 3); INSTR, 554/754, EN (6025362-025 2); Artwork, New, Feature, (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-554/754 PRDGM VEO PUMP W/ENLITE, Nordic Cover, EN, OUS (MP6025679-025 1); Artwork, CRB D Process; Instr, X54, Paradigm, Nordic, EN (MP6025679-023 3); Artwork, CRB A Process; Instr, X54, Paradigm, Nordic, EN (MP6025679-024 1)
Apr 8, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
(1) System Code: 722008; UDI: N/A; System Serial Number: 360, 361, 445, 296, 487, 390, 306, 178, 420, 267, 245, 2470, 491, 113, 386, 69, 413, 365, 454, 304, 442, 125, 441, 320, 325, 112, 254, 456, 52, 34, 239, 407, 187, 437, 82, 102, 288, 349, 106, 105, 481, 71, 424, 1236, 197, 264, 18, 19, 192, 124, 483, 244, 224, 470, 279, 141, 459, 357, 287, 116, 521, 369, 212, 23, 415, 100, 294, 270, 372, 472, 18270, 154, 231, 108, 1178, 246, 115, 460, 319, 465, 142, 419, 312, 37, 59, 455, 217, 350, 406, 160, 167, 435, 447, 410, 196, 458, 480, 476, 370, 169, 121, 259, 266, 186, 290, 253, 359, 391, 283, 205, 425, 346, 376, 150, 394, 123, 513, 337, 93, 268, 200, 87, 110, 46, 542, 334, 122, 8, 468, 250, 482, 63, 408, 305, 213, 547, 546, 475, 356, 404, 398, 31, 553; (2) System Code: 722013; UDI: 00884838059061; System Serial Number: 293, 424, 100, 174, 86, 83, 46, 170, 218, 441, 249, 639, 290, 153, 410, 1, 289, 518, 519, 626, 126, 141, 496, 379, 115, 42, 601, 214, 637, 360, 389, 303, 268, 264, 631, 254, 255, 515, 129, 15, 603, 278, 347, 426, 505, 109, 462, 149, 124, 216, 246, 84, 479, 69, 105, 638, 375, 531, 404, 575, 147, 475, 262, 125, 316, 497, 357, 495, 573, 342, 564, 164, 178, 556, 253, 297, 511, 492, 43, 550, 96, 179, 228, 194, 151, 106, 330, 461, 304, 40, 85, 72, 241, 422, 267, 150, 428, 634, 327, 442, 175, 217, 313, 346, 308, 562, 309, 152, 34, 561, 35, 205, 61, 435, 266, 567, 168, 607, 283, 52, 171, 66, 36, 585, 271, 117, 443, 107, 138, 223, 343, 165, 453, 370, 367, 108, 352, 291, 259, 455, 368, 315, 325, 532, 598, 440, 172, 193, 301, 415, 540, 62, 299, 183, 184, 185, 186, 187, 188, 189, 190, 413, 437, 560, 300, 295, 448, 81, 444, 400, 110, 111, 624, 65, 633, 630, 361, 549, 417, 449, 506, 177, 629, 476, 527, 276, 247, 156, 499, 50, 302, 618, 608, 133, 70, 457, 547, 312, 366, 390, 544, 236, 157, 243, 144, 238, 525, 53, 570, 161, 349, 359, 454, 613, 623, 222, 215, 335, 445, 538, 416, 628, 619, 47, 206, 620, 384, 526, 332, 358, 470, 378, 296, 227, 31, 58, 589, 616, 71, 447, 530, 232, 324, 311, 176, 181, 554, 134, 163, 104, 403, 478, 459, 17, 528, 318, 28, 237, 559, 372, 256, 374, 487, 405, 380, 434, 130, 473, 551, 557, 294, 412, 128, 388, 207, 258, 429, 95, 411, 353, 542, 533, 622, 182, 574, 139, 137, 250, 563, 502, 450, 436, 406, 354, 510, 395, 458, 261, 348, 503, 595, 586, 535, 569, 425, 334, 344, 355, 465, 345, 522, 64, 208, 408, 555, 394, 57, 493;
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Real-Time Insulin Pump: 00613994409423, 00613994622600, 613994622747, 613994407733, 00613994407740, 00613994136374, 00613994271600, 00613994106476, 00613994373120, 00613994409478, 00613994312426, 00613994151780, 00885074419831, 00613994622747, 00613994951502, 00613994622648, 00643169026100, 00613994622624, 00613994622556, 00613994402011, 00613994409553, 00613994368485, 00613994368508, 00613994368522, 00613994108739, 00613994368607, 00613994368492, 00613994368515, 00613994123084, 00613994124814, 00613994402523, 00613994402530, 00613994402516, 00613994401502, 00613994402509, 00613994405913, 00613994123206, 00643169688421, 00643169199699, 00643169199675, 00613994409461, 00613994124777, 00643169572492, 00613994267177, 00643169848054, 00613994266897, 00613994310804, 00613994310798, 00613994310774, 00613994310903, 00613994401564, 00613994401663, 00613994402554, 00613994402462, 00613994402592, 00613994402608, 00613994405944, 00613994402455, 00613994402547, 00613994402479, 00763000069292, 00613994402578, 00613994409447, 00643169729438, 00763000069254, 00763000084325, 00613994402486, 00613994405920, 00763000069261, 00613994948595, 00613994929778, 00613994224569, 00613994929808, 00613994930361, 00613994929761, 00643169199705, 00643169199668, 00643169496248, 00643169848016, 00643169848023, 00763000161095,00613994123329, 00613994125026, 00613994247728, 00613994124692, 00613994124739, 00613994266903, 00613994267153, 00613994266880, 00613994267207, 00613994310866, 00613994310811, 00613994310781, 00613994310873, 00613994310613, 00613994310910, 00613994310880, 00613994310767, 00613994375025, 00613994368638, 00613994368553, 00613994368560, 00613994405937, 00613994368539, 00613994368546, 00613994377586, 00613994368591, 00613994368584, 00613994368577, 00613994402585, 00613994402561, 00613994401588, 00613994929815, 00643169221970, 00763000069247, 00763000090654, 00763000640163, 00613994601629, 00643169354975, 00613994401977, 00763000084332, 00643169919389, 00763000161118, 00763000161071: Artwork, CRB D Process, Instr, 522/722, NA(MP6025250-013DOC); Artwork, CRB D Process, Paradigm¿ 522 and 722 Insulin Pumps User(MP6025681-022DOC); Artwork, CRB A Process, Instr, 522/722,Block Mode,TST,Nordic,EN(MP6025681-023DOC); Artwork, CRB D Process, Instr, 522/722 with Enlite, OUS, EN(MP6025646-021DOC); Artwork, CRB D Process, Instr, 522/722, w/Enlite, OUS, EN(MP6025646-022DOC); Artwork, CRB A Process, Instr, 522/722, w/Enlite, OUS, EN(MP6025646-023DOC); Artwork, CRB A Process, Instr, 522/722, w/Enlite, OUS, EN(MP6025646-023DOC); Artwork, New, Feature (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-522/722 PRDGM X22 PUMP W/ENLITE, EN, OUS(MP6025646-024DOC); Artwork, New, Feature (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-522/722 PRDGM X22 PUMP W/ENLITE, EN, OUS(MP6025646-024DOC); Artwork, New, Feature (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-522/722 PRDGM X22 PUMP W/ENLITE, EN, OUS - Nordic cover (MP6025681-024DOC);
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 670G Insulin Pump: 643169946057, 763000096984, 763000090203, 763000165468, 763000190460, 763000190453, 763000216481, 763000187422, 763000187415, 763000165413, 763000165475, 763000367657, 763000289065, 763000264710, 763000283476, 763000283544, 763000283520, 763000283445, 763000393786, 763000289058, 763000374532, 763000283537, 763000365899, 763000371937, 763000283513, 763000165451, 763000165420, 763000165444, 763000165437, 763000165499, 763000165482, 763000165536, 763000165512, 763000165550, 763000165529, 763000235772, 763000165505, 763000235765, 763000165543, 763000257309, 763000283568, 763000283599, 763000289041, 763000289089, 763000289195, 763000289072, 763000289119, 763000289188, 763000289133, 763000289126, 763000289171, 763000289102, 763000404543, 763000289096, 763000289164, 763000404536, 763000324797, 763000264727, 763000324780, 763000283551, 763000283582, 763000374518, 763000374525, 763000374556, 763000374624, 763000374594, 763000374600, 763000399849, 763000399856, 763000408916, 763000408947, 763000371944, 763000365905, 763000374587, 763000408930, 763000283575, 763000157463, 763000203313, 763000252076, 763000283506, 763000411787, 643169946057, 763000096984, 763000190453, 763000283445, 763000395858, 763000278427, 763000090203, 763000283513, 763000365882, 763000283506, 76300028351303, 763000393786, 76300028351301, 763000166526, 643169939202, 763000190460, 763000283520, 763000072537, 763000256821, 643169939219, 763000187415, 763000283568: MiniMed670G System User Guide(M979513A011 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MINIMED 670G SYSTEM USER GUIDE(M988666A021 1, M979513A011 1, M985214A021 1, M985214A261 1, M974439A181 1, M974439A062 1, M974439A032 1, M974439A043 1, M974439A073 1, M974439A103 1, M974439A052 1, M020098C001 3, M020098C003 1, M974439A165 1, M974439A093 1, M974439A083 1); MINIMED 670G SYSTEM USER GUIDE mg/dL(M974449A111 1, M974449A073 1, M974449A103 1, M974449A023 1, M974449A093 1, M974449A083 1, M974449A113 1); MINIMED 670G SYSTEM USER GUIDE mmol/L(M974439A024 1).
Apr 8, 2026
View details →Civco medical instruments co. inc.
High PriorityActive
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
UDI-DI: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840
Apr 8, 2026
View details →Burlington medical, llc
High PriorityActive
Burlington Medical, Wrap Aprons.
Potential for attenuation degradation over time, decreasing the lifespan.
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8EURO; UDI-DI (Product Code): 00840331297683 (WRAPC8-C8EURO-LF ), 00840331297683 (WRAPC8-C8EURO-LM ), 00840331297683 (WRAPC8-C8EURO-MF ), 00840331297683 (WRAPC8-C8EURO-MM ), 00840331297683 (WRAPC8-C8EURO-SF ), 00840331297683 (WRAPC8-C8EURO-SM ), 00840331297683 (WRAPC8-C8EURO-XLM ), 00840331297683 (WRAPT18-C8EURO-LF ), 00840331297683 (WRAPT18-C8EURO-LM ), 00840331297683 (WRAPT18-C8EURO-MM ), 00840331297683 (WRAPT18-C8EURO-PLUS ), 00840331297683 (WRAPT18-C8EURO-SM ). 2. Model Number: C8F111; UDI-DI (Product Code): 00840331297690 (WRAPT18-C8F111-MM). 3. Model Number: R8EURO; UDI-DI (Product Code): 00840331258721 (WRAPC18-R8EURO-2XF ), 00840331258738 (WRAPC18-R8EURO-2XM ), 00840331258745 (WRAPC18-R8EURO-3XF ), 00840331258752 (WRAPC18-R8EURO-3XM ), 00840331258769 (WRAPC8-R8EURO-LF ), 00840331258776 (WRAPC8-R8EURO-LM ), 00840331258783 (WRAPC8-R8EURO-MF ), 00840331258790 (WRAPC8-R8EURO-MM ), 00840331258806 (WRAPC8-R8EURO-PLUS ), 00840331258813 (WRAPC8-R8EURO-SF ), 00840331258820 (WRAPC8-R8EURO-SM ), 00840331258837 (WRAPC8-R8EURO-XLF ), 00840331258844 (WRAPC8-R8EURO-XLM ), 00840331258851 (WRAPC8-R8EURO-XSF ), 00840331258868 (WRAPC8-R8EURO-XSM ), 00840331258769 (WRAPS8-R8EURO-LF ), 00840331258776 (WRAPS8-R8EURO-LM ), 00840331258783 (WRAPS8-R8EURO-MF ), 00840331258790 (WRAPS8-R8EURO-MM ), 00840331258813 (WRAPS8-R8EURO-SF ), 00840331258820 (WRAPS8-R8EURO-SM ), 00840331258837 (WRAPS8-R8EURO-XLF ), 00840331258844 (WRAPS8-R8EURO-XLM ), 00840331270044 (WRAPT18-R8EURO-LF ), 00840331270051 (WRAPT18-R8EURO-LM ), 00840331270051 (WRAPT18-R8EURO-MF ), 00840331270051 (WRAPT18-R8EURO-MM ), 00840331270044 (WRAPT18-R8EURO-PLUS ), 00840331270044 (WRAPT18-R8EURO-SF ), 00840331270051 (WRAPT18-R8EURO-SM ), 00840331270044 (WRAPT18-R8EURO-XLF ), 00840331270051 (WRAPT18-R8EURO-XLM ), 00840331270051 (WRAPT18-R8EURO-XSM ), 00840331270044 (WRAPT28-R8EURO-2XF ), 00840331270051 (WRAPT28-R8EURO-2XM ), 00840331270044 (WRAPT28-R8EURO-3XF ), 00840331270051 (WRAPT28-R8EURO-3XM ), 00840331270044 (WRAPT28-R8EURO-4XF ), 00840331270051 (WRAPT28-R8EURO-4XM ), 00840331270044 (WRAPT28-R8EURO-5XF ), 00840331270051 (WRAPT28-R8EURO-5XM ), 00840331270044 (WRAPT38-R8EURO-6XF ), 00840331270051 (WRAPT38-R8EURO-6XM ), 00840331270044 (WRAPT38-R8EURO-7XF ), 00840331270051 (WRAPT38-R8EURO-7XM ), 00840331270044 (WRAPT38-R8EURO-8XF ), 00840331270051 (WRAPT38-R8EURO-8XM ), None (IWRAPC8-R8EURO-LFR ), None (IWRAPC8-R8EURO-MFR ), None (IWRAPC8-R8EURO-PLUSL ), None (IWRAPC8-R8EURO-SFS ). 4. Model Number: R8F111; UDI-DI (Product Code): 00840331259049 (WRAPC18-R8F111-2XF ), 00840331259056 (WRAPC18-R8F111-2XM ), 00840331259063 (WRAPC18-R8F111-3XF ), 00840331259087 (WRAPC8-R8F111-LF ), 00840331259094 (WRAPC8-R8F111-LM ), 00840331259100 (WRAPC8-R8F111-MF ), 00840331259117 (WRAPC8-R8F111-MM ), 00840331259124 (WRAPC8-R8F111-PLUS ), 00840331259131 (WRAPC8-R8F111-SF ), 00840331259148 (WRAPC8-R8F111-SM ), 00840331259155 (WRAPC8-R8F111-XLF ), 00840331259162 (WRAPC8-R8F111-XLM ), 00840331270105 (WRAPT18-R8F111-LF ), 00840331270112 (WRAPT18-R8F111-LM ), 00840331270105 (WRAPT18-R8F111-MF ), 00840331270112 (WRAPT18-R8F111-MM ), 00840331270105 (WRAPT18-R8F111-PLUS ), 00840331270105 (WRAPT18-R8F111-SF ), 00840331270112 (WRAPT18-R8F111-SM ), 00840331270105 (WRAPT18-R8F111-XLF ), 00840331270112 (WRAPT18-R8F111-XLM ), 00840331270112 (WRAPT18-R8F111-XSM ), 00840331270105 (WRAPT28-R8F111-2XF ), 00840331270112 (WRAPT28-R8F111-2XM ), 00840331270105 (WRAPT28-R8F111-3XF ), 00840331270112 (WRAPT28-R8F111-3XM ), 00840331270105 (WRAPT28-R8F111-4XF ), 00840331270112 (WRAPT28-R8F111-4XM ), 00840331270105 (WRAPT28-R8F111-5XF ), 00840331270112 (WRAPT28-R8F111-5XM ), 00840331270105 (WRAPT38-R8F111-6XF ), 00840331270112 (WRAPT38-R8F111-6XM ), 00840331270112 (WRAPT38-R8F111-8XM ), None (IWRAPC8-R8F111-MML ). 5. Model Number: R8F112; UDI-DI (Product Code): 00840331259209 (WRAPC18-R8F112-2XF ), 00840331259223 (WRAPC18-R8F112-3XF ), 00840331259247 (WRAPC8-R8F112-LF ), 00840331259254 (WRAPC8-R8F112-LM ), 00840331259261 (WRAPC8-R8F112-MF ), 00840331259278 (WRAPC8-R8F112-MM ), 00840331259292 (WRAPC8-R8F112-SF ), 00840331259308 (WRAPC8-R8F112-SM ), 00840331259315 (WRAPC8-R8F112-XLF ), 00840331259322 (WRAPC8-R8F112-XLM ), 00840331259339 (WRAPC8-R8F112-XSF ), 00840331259346 (WRAPC8-R8F112-XSM ), 00840331270167 (WRAPT18-R8F112-LF ), 00840331270174 (WRAPT18-R8F112-LM ), 00840331270167 (WRAPT18-R8F112-MF ), 00840331270174 (WRAPT18-R8F112-MM ), 00840331270167 (WRAPT18-R8F112-PLUS ), 00840331270167 (WRAPT18-R8F112-SF ), 00840331270174 (WRAPT18-R8F112-SM ), 00840331270167 (WRAPT18-R8F112-XLF ), 00840331270174 (WRAPT18-R8F112-XLM ), 00840331270174 (WRAPT18-R8F112-XSM ), 00840331270174 (WRAPT28-R8F112-2XM ), 00840331270167 (WRAPT28-R8F112-3XF ), 00840331270174 (WRAPT28-R8F112-4XM ), 00840331270167 (WRAPT28-R8F112-5XF ), 00840331270105 (WRAPT38-R8F112-6XF ), 00840331270105 (WRAPT38-R8F112-7XF ), 00840331270112 (WRAPT38-R8F112-7XM ), None (IWRAPC8-R8F112-2XML ), None (IWRAPC8-R8F112-LFR ), None (IWRAPC8-R8F112-LMR ), None (IWRAPC8-R8F112-MFR ), None (IWRAPC8-R8F112-MFS ), None (IWRAPC8-R8F112-MMR ), None (IWRAPC8-R8F112-MMS ), None (IWRAPC8-R8F112-PLUSL ), None (IWRAPC8-R8F112-PLUSR ), None (IWRAPC8-R8F112-SFS ), None (IWRAPC8-R8F112-SMS ), None (IWRAPC8-R8F112-XLFL ), None (IWRAPC8-R8F112-XLML ), None (IWRAPC8-R8F112-XSFS ), None (IWRAPC8-R8F112-XSMS ), None (IWRAPC8-R8F112-MML ). 6. Model Number: R8P600; UDI-DI (Product Code): 00197513001126 (PWRAPC8-R8P600-MD ). 7. Model Number: R8W113; UDI-DI (Product Code): 00197513007906 (WRAPC18-R8W113-2XF ), 00197513007890 (WRAPC18-R8W113-2XM ), 00197513007043 (WRAPC8-R8W113-MF ), 00197513007036 (WRAPC8-R8W113-MM ). 8. Model Number: R8W114; UDI-DI (Product Code): 00197513010210 (WRAPC18-R8W114-2XF ), 00197513010203 (WRAPC18-R8W114-2XM ), 00197513009351 (WRAPC8-R8W114-MF ), 00197513009344 (WRAPC8-R8W114-MM ). 9. Model Number: S8EURO; UDI-DI (Product Code): 00840331262476 (WRAPC18-S8EURO-2XF ), 00840331262483 (WRAPC18-S8EURO-2XM ), 00840331262490 (WRAPC18-S8EURO-3XF ), 00840331262506 (WRAPC18-S8EURO-3XM ), 00840331262513 (WRAPC8-S8EURO-LF ), 00840331262520 (WRAPC8-S8EURO-LM ), 00840331262537 (WRAPC8-S8EURO-MF ), 00840331262544 (WRAPC8-S8EURO-MM ), 00840331262551 (WRAPC8-S8EURO-PLUS ), 00840331262568 (WRAPC8-S8EURO-SF ), 00840331262575 (WRAPC8-S8EURO-SM ), 00840331262582 (WRAPC8-S8EURO-XLF ), 00840331262599 (WRAPC8-S8EURO-XLM ), 00840331262605 (WRAPC8-S8EURO-XSF ), 00840331262612 (WRAPC8-S8EURO-XSM ), 00840331262513 (WRAPS8-S8EURO-LF ), 00840331262520 (WRAPS8-S8EURO-LM ), 00840331262537 (WRAPS8-S8EURO-MF ), 00840331262544 (WRAPS8-S8EURO-MM ), 00840331262568 (WRAPS8-S8EURO-SF ), 00840331262575 (WRAPS8-S8EURO-SM ), 00840331262599 (WRAPS8-S8EURO-XLM ), 00840331270068 (WRAPT18-S8EURO-LF ), 00840331270075 (WRAPT18-S8EURO-LM ), 00840331270068 (WRAPT18-S8EURO-MF ), 00840331270075 (WRAPT18-S8EURO-MM ), 00840331270068 (WRAPT18-S8EURO-PLUS ), 00840331270068 (WRAPT18-S8EURO-SF ), 00840331270075 (WRAPT18-S8EURO-SM ), 00840331270068 (WRAPT18-S8EURO-XLF ), 00840331270075 (WRAPT18-S8EURO-XLM ), 00840331270068 (WRAPT18-S8EURO-XSF ), 00840331270075 (WRAPT18-S8EURO-XSM ), 00840331270068 (WRAPT28-S8EURO-2XF ), 00840331270075 (WRAPT28-S8EURO-2XM ), 00840331270068 (WRAPT28-S8EURO-3XF ), 00840331270075 (WRAPT28-S8EURO-3XM ), 00840331270068 (WRAPT28-S8EURO-4XF ), 00840331270075 (WRAPT28-S8EURO-4XM ), 00840331270068 (WRAPT28-S8EURO-5XF ), 00840331270075 (WRAPT28-S8EURO-5XM ), 00840331270068 (WRAPT38-S8EURO-6XF ), 00840331270075 (WRAPT38-S8EURO-6XM ), 00840331270068 (WRAPT38-S8EURO-7XF ), 00840331270075 (WRAPT38-S8EURO-7XM ), 00840331270068 (WRAPT38-S8EURO-8XF ), 00840331270075 (WRAPT38-S8EURO-8XM ). 10. Model Number: S8F111; UDI-DI (Product Code): 00840331262797 (WRAPC18-S8F111-2XF ), 00840331262803 (WRAPC18-S8F111-2XM ), 00840331262834 (WRAPC8-S8F111-LF ), 00840331262841 (WRAPC8-S8F111-LM ), 00840331262841 (WRAPC8-S8F111-MF ), 00840331262865 (WRAPC8-S8F111-MM ), 00840331262872 (WRAPC8-S8F111-PLUS ), 00840331262889 (WRAPC8-S8F111-SF ), 00840331262896 (WRAPC8-S8F111-SM ), 00840331262902 (WRAPC8-S8F111-XLF ), 00840331262919 (WRAPC8-S8F111-XLM ), 00840331270129 (WRAPT18-S8F111-LF ), 00840331270136 (WRAPT18-S8F111-LM ), 00840331270129 (WRAPT18-S8F111-MF ), 00840331270136 (WRAPT18-S8F111-MM ), 00840331270129 (WRAPT18-S8F111-PLUS ), 00840331270129 (WRAPT18-S8F111-SF ), 00840331270136 (WRAPT18-S8F111-SM ), 00840331270129 (WRAPT18-S8F111-XLF ), 00840331270136 (WRAPT18-S8F111-XLM ), 00840331270136 (WRAPT18-S8F111-XSM ), 00840331270129 (WRAPT28-S8F111-2XF ), 00840331270136 (WRAPT28-S8F111-2XM ), 00840331270129 (WRAPT28-S8F111-3XF ), 00840331270136 (WRAPT28-S8F111-3XM ), 00840331270129 (WRAPT28-S8F111-4XF ), 00840331270136 (WRAPT28-S8F111-4XM ), 00840331270129 (WRAPT28-S8F111-5XF ), 00840331270136 (WRAPT28-S8F111-5XM ), 00840331270129 (WRAPT38-S8F111-6XF ), 00840331270136 (WRAPT38-S8F111-6XM ), 00840331270129 (WRAPT38-S8F111-8XF ), 00840331270136 (WRAPT38-S8F111-8XM ). 11. Model Number: S8F112; UDI-DI (Product Code): 00840331262964 (WRAPC18-S8F112-2XM ), 00840331262995 (WRAPC8-S8F112-LF ), 00840331263008 (WRAPC8-S8F112-LM ), 00840331263015 (WRAPC8-S8F112-MF ), 00840331263022 (WRAPC8-S8F112-MM ), 00840331263046 (WRAPC8-S8F112-SF ), 00840331263053 (WRAPC8-S8F112-SM ), 00840331263077 (WRAPC8-S8F112-XLM ), 00840331270181 (WRAPT18-S8F112-LF ), 00840331270198 (WRAPT18-S8F112-LM ), 00840331270181 (WRAPT18-S8F112-MF ), 00840331270198 (WRAPT18-S8F112-MM ), 00840331270181 (WRAPT18-S8F112-PLUS ), 00840331270198 (WRAPT18-S8F112-SM ), 00840331270181 (WRAPT18-S8F112-XLF ), 00840331270198 (WRAPT18-S8F112-XLM ), 00840331270181 (WRAPT28-S8F112-2XF ), 00840331270198 (WRAPT28-S8F112-2XM ), 00840331270198 (WRAPT28-S8F112-3XM ), 00840331270181 (WRAPT28-S8F112-4XF ), 00840331270198 (WRAPT28-S8F112-5XM ). 12. Model Number: S8W113; UDI-DI (Product Code): 00197513000594 (WRAPT28-S8W113-3XF ). 13. Model Number: U8EURO; UDI-DI (Product Code): 00840331266207 (WRAPC18-U8EURO-2XF ), 00840331266214 (WRAPC18-U8EURO-2XM ), 00840331266245 (WRAPC8-U8EURO-LF ), 00840331266252 (WRAPC8-U8EURO-LM ), 00840331266269 (WRAPC8-U8EURO-MF ), 00840331266269 (WRAPC8-U8EURO-MM ), 00840331266283 (WRAPC8-U8EURO-PLUS ), 00840331266306 (WRAPC8-U8EURO-SM ), 00840331266313 (WRAPC8-U8EURO-XLF ), 00840331266320 (WRAPC8-U8EURO-XLM ), 00840331266337 (WRAPC8-U8EURO-XSF ), 00840331266344 (WRAPC8-U8EURO-XSM ), 00840331266245 (WRAPS8-U8EURO-LF ), 00840331266252 (WRAPS8-U8EURO-LM ), 00840331266269 (WRAPS8-U8EURO-MF ), 00840331266276 (WRAPS8-U8EURO-MM ), 00840331266306 (WRAPS8-U8EURO-SM ), 00840331266320 (WRAPS8-U8EURO-XLM ), 00840331270082 (WRAPT18-U8EURO-LF ), 00840331270099 (WRAPT18-U8EURO-LM ), 00840331270082 (WRAPT18-U8EURO-MF ), 00840331270099 (WRAPT18-U8EURO-MM ), 00840331270082 (WRAPT18-U8EURO-PLUS ), 00840331270082 (WRAPT18-U8EURO-SF ), 00840331270099 (WRAPT18-U8EURO-SM ), 00840331270082 (WRAPT18-U8EURO-XLF ), 00840331270099 (WRAPT18-U8EURO-XLM ), 00840331270099 (WRAPT18-U8EURO-XSM ), 00840331270082 (WRAPT28-U8EURO-2XF ), 00840331270099 (WRAPT28-U8EURO-2XM ), 00840331270082 (WRAPT28-U8EURO-3XF ), 00840331270099 (WRAPT28-U8EURO-3XM ), 00840331270082 (WRAPT28-U8EURO-4XF ), 00840331270099 (WRAPT28-U8EURO-4XM ), 00840331270082 (WRAPT28-U8EURO-5XF ), 00840331270099 (WRAPT28-U8EURO-5XM ), 00840331270082 (WRAPT38-U8EURO-6XF ), 00840331270099 (WRAPT38-U8EURO-6XM ), 00840331270082 (WRAPT38-U8EURO-7XF ), 00840331270099 (WRAPT38-U8EURO-7XM ), 00840331270099 (WRAPT38-U8EURO-8XM ). 14. Model Number: U8F111; UDI-DI (Product Code): 00840331266566 (WRAPC8-U8F111-LF ), 00840331266573 (WRAPC8-U8F111-LM ), 00840331266580 (WRAPC8-U8F111-MF ), 00840331266597 (WRAPC8-U8F111-MM ), 00840331266603 (WRAPC8-U8F111-PLUS ), 00840331266634 (WRAPC8-U8F111-XLF ), 00840331266641 (WRAPC8-U8F111-XLM ), 00840331270143 (WRAPT18-U8F111-LF ), 00840331270150 (WRAPT18-U8F111-LM ), 00840331270143 (WRAPT18-U8F111-MF ), 00840331270150 (WRAPT18-U8F111-MM ), 00840331270143 (WRAPT18-U8F111-PLUS ), 00840331270150 (WRAPT18-U8F111-SM ), 00840331270143 (WRAPT18-U8F111-XLF ), 00840331270150 (WRAPT18-U8F111-XLM ), 00840331270143 (WRAPT28-U8F111-2XF ), 00840331270150 (WRAPT28-U8F111-2XM ), 00840331270150 (WRAPT28-U8F111-3XM ), 00840331270143 (WRAPT28-U8F111-4XF ), 00840331270150 (WRAPT28-U8F111-4XM ), 00840331270143 (WRAPT28-U8F111-5XF ), 00840331270143 (WRAPT38-U8F111-6XF ), 00840331270150 (WRAPT38-U8F111-6XM ), 00840331270143 (WRAPT38-U8F111-7XF ), None (IWRAPC8-U8F111-2XMR ), None (IWRAPC8-U8F111-LMR ), None (IWRAPC8-U8F111-MMR ), None (IWRAPC8-U8F111-SMR ), None (IWRAPC8-U8F111-XLMR ). 15. Model Number: U8F112; UDI-DI (Product Code): 00840331266740 (WRAPC8-U8F112-MF ), 00840331270211 (WRAPT18-U8F112-MM ), 00840331270211 (WRAPT18-U8F112-XLM ), 00840331270211 (WRAPT28-U8F112-4XM ), 00840331270204 (WRAPT28-U8F112-5XF ), None (IWRAPC8-U8F112-2XMR ), None (IWRAPC8-U8F112-LMR ), None (IWRAPC8-U8F112-MMR ), None (IWRAPC8-U8F112-SMR ), None (IWRAPC8-U8F112-XLMR ), None (IWRAPC8-U8F112-XLMXL ). 16. Model Number: U8W113; UDI-DI (Product Code): 00197513000587 (WRAPT28-U8W113-3XF ). 17. Model Number: R8EURO; UDI-DI (Product Code): None (IWRAPC8-R8EURO-LMR).
Apr 8, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 720G Insulin Pump: 763000854768, 763000505196, 763000505219, 763000505318, 763000505257, 763000505295, 763000505233, 763000505370, 763000505325, 763000505332, 763000505394, 763000505356, 763000505387, 763000505349, 763000505400, 763000505226, 763000505271, 763000638016, 763000531171, 763000854751: MINIMED 720G SYSTEM USER GUIDE(M000187C022 1, M000186C002 1, M000186C014 1, M000187C016 1, M000186C021 1, M000186C018 1, M000186C017 1, M000187C010 1, M000187C011 1, M000186C031 1, M000187C013 1, M000187C008 1, M000187C015 1, M000187C005 1, M000187C033 1, M000186C028 1, M000187C023 1, M000187C020 1, M000187C018 1, M000186C018 13, M000186C004 1, M000186C030 1, M000186C009 1, M000187C024 1, M000186C033 1, M000186C003 1, M000187C012 1).
Apr 8, 2026
View details →Medline industries, lp
High PriorityActive
THORACIC ROBOTS, DYNJ908777B
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
UDI-DI 10198459269196 (EA) 40198459269197 (CS) LOTS 25EBD732 25GBG733 25IBQ613 25JBD457 25KBT352 26ABA235 26ABP735
Apr 8, 2026
View details →Intuitive surgical, inc.
High PriorityActive
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Lot Code: 420183, Permanent Cautery Hook GTIN: 00886874111536 FDA Medical Listing Number: D088920 Material Numbers: 420183-05 System Numbers: USG294 SH0059 SH0075 SH0059 USG294 Material Number: 420183-06 da Vinci System Numbers: SH1378 SH1378 SH0729 SH1182 USG294 USG294 USG294 SH1015 SH0729 USG294 SH0825 SH1390 SG704 SH0935 SG704 USG022 SH1182 SH0729 SH1390 SH1276 USG294 SH1182 SG704 SH1182 SH1276 SH1076 USG294 SH1015 SH1076 SH1390 USG022 SH2144 SH1182 SH0825 SH1182 SH0547 USG689 SH1385 USG689 USG294 SH1276 SH1076 SH1276 SH0729 SH0059 SH1604 SH0825 USG294 SH1276 SH1378 SH1622 SH1182 SH0059 SH1182 SH1276 SH1276 USG689 USG294 SH1182 SH1276 SH1378 USG518 SH1182 SH1570 SH1276 SH1182 SH0035 SH0825 SH0035 SH1837 SH1276 USG294 SH0059 SH1368 SH1276 SH1570 SH1378 SH1182 SH1378 SH1378 SH0547 SH1276 SH1276 USG518 SH1276 SH1182 SH1015 SH0495 SH1182 SH1390 SH1378 SH1182 SH1276 SH0825 SH1378 SG704 SH1378 SH1276 SH1182 SH0547 SH0935 SH0547 SH1622 SH1182 SH1557 USG294 SH0495 SH1276 SH1557 SH1276 SH1182 SH1391 SH1276 SH1557 SH2186 SH1182 SH1391 SH1182 SH1997 USG294 SH1997 SH2125 SH1276 SH2125 SH1276 SH1182 Material Number: 420183-10 da Vinci System Numbers: SH1182 SH0825 SH1276 SH1182 SH2125 SH1182 USG294 USG294 SH1182 SH1182 SH0547 SH1378 SH0495 SH1182 SH1997 SH1182 SH1276 SH0825 USG518 SH1182 SH1276 SH1276 SH2125 SH0825 SH1182 SH1182 SH1837 SH0935 SH2144 SH0935 SH2125 SH1182 SH1378 SH0935 SH1276 SH1182 SH1622 SH1390 SH2125 SH1557 SH1182 SH1368 SH0935 SH1557 SH1182 SH0495 SH2125 SH0935 SH1182 SH0547 SG704 SH1182 SH1279 SH1557 SH0825 SH2125 SH1076 Material Number: 420183-11 da Vinci System Numbers: SH1390 SH1182 SH2125 SH1557 SG704 SH1015 USG294 SH1015 SH1182 SH1182 USG294 SH1182 SH0935 SH0935 SH1390 SH2125 SH1182 SH1570 SH1182 SH1015 SH2125 USG294 SH1076 SH1378 SH1557 USG689 USG022 SH0035 SH0059 SH1390 SH2125 SH0935 SH1182 SH1015 SH1182 SH1604 SH2125 SH1182 SH1015 SH1182 SH1622 SH1182 SH0059 SH1015 SH1015 SH0935 SH0935 Material Number: 420183-12 da Vinci System Numbers: SH1390 SH2125 SH1182 SH0935 SH1182 SH0059 SH1015 SH0935 SH2125 SH1182 USG518 USG294 SH1182 SH2125 SH1182 SH1570 SH1182 SH1182 SG704 SH2125 SH1182 SH1557 SG704 SH1182 USG294 SH1557 SH2125 USG294 SH1182 SH1557 SH2125 SH0935 SH0825 SH0729 SH1182 SH1557 SH0059 SH1622 SH1182 USG294 SH1378 SH1557 SH2125 SH1076 SH1822 USG294 SH1182 SH1557 SH0825 SH1182 SH0495 SH2125 SH1557 SH2144 SH2125 SG704 SH0059 SH2125 SH1604 Material Number: 420183-14 da Vinci System Numbers: SH1182 SH2125 SH1182 SH2144 SH2144 USG294 SH1622 SH2125 SH1182 SH1182 SH1822 SH2125 USG721 SH0729 SH1822 SG704 SH2125 SH0825 SH1015 SH1182 SH1182 SH2125 SH1997 SH1622 SH0825 SH2186 SH2180 SH1822 SH0729 SH1015 SH1015 SH2144 SH1822 SH2125 USG721 SH1182 SH1182 SH1997 USG294 SH2186 SH1182 SH0495 SH1997 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Numbers: 420183-16 da Vinci System Number: SH1997
Apr 8, 2026
View details →Ge healthcare llc
High PriorityActive
SIGNA Premier systems
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
UDI-DI/GTIN: 00840682135269, 00195278010797. System ID: 415353UMR2, 415723SHMR19, 413253MR3T, 908725MR, 609652MR3T, M48823, 7168453T, 513584MR5, 513636EASTMR, 513636T1MR, 605333MRPRM, 832522CRMR1, 703858PRE2, 804675VA3T, 082427110162, 082427220143, 082427020147, 082427200242, 082427160461, 082427250139, 082427140382, M4216469, 353745MR01, GON5655515, KRMR56474971, KRMR56203791, KRMR55433661, KRMR56344161, KRMR55774051, KRMR55914661, NOMRI26833321, 15974045, GON1882380, ESMRI27056983, ESMRI26960129, A203MR06, 690120MR01, 11524261, VNMRI26792525, VNMRI26592248, VNMRI26809677
Apr 8, 2026
View details →I.t.s. gmbh
High PriorityActive
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), 21232-6 (26/F62564, 26/F65638), 21233-3 (26/F65639), 21233-4 (26/F65640), 21233-6 (26/F61723, 26/F65046), 21234-4 (26/F65641, 26/F66504), 21235-4 (26/F65642, 26/F67810). 2. Article Number (Lot Numbers): 21231-6 (643/012301, 643/022310, 643/032308, 643/0630, 643/0657, 643/102402, 643/122301). 3. Article Number (Lot Numbers): 37302-18 (18/636447), 37302-20 (18/802189).
Apr 1, 2026
View details →Philips ultrasound, inc
High PriorityActive
Philips L17-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605366371, 989605388061; UDI: N/A; Serial No. 03228X, 03360Q.
Apr 1, 2026
View details →Philips respironics, inc.
High PriorityActive
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
All Model No.; All UDI; All Serial No.
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Article Number (Lot Numbers): 31207-10 (679/112002), 31207-12 (679/092133, 679/102343, 679/112006), 31207-14 (679/102050), 31207-16 (679/102345, 679/102049), 31207-18 (679/0323110, 679/102355, 679/112001), 31207-20 (679/0323111, 679/102051, 679/102356), 31207-24 (679/102028), 31207-26 (679/112008), 31207-28 (679/112009), 31207-30 (679/0323140, 86/483377), 31257-12 (679/081904), 31257-14 (679/042323, 679/081905), 31257-16 (679/042324), 31257-18 (679/112308, 679/022128), 31257-20 (679/022123, 679/042326, 679/112321), 31257-22 (679/022124, 679/042327, 679/112325), 31257-24 (679/022125, 679/112326), 31257-28 (679/022130, 679/052306), 31257-30 (679/022131), 31307-18 (679/061907), 31307-32 (679/062285), 31307-34 (679/062286), 31307-36 (679/062287), 31307-38 (679/032118), 31358-30 (26/F67790), 31437-30 (679/071916), 31437-38 (679/071918), 31437-40 (679/032406, 679/071903), 31437-50 (679/071920), 31757-100 (35/51892), 31757-120 (86/320792), 31757-45 (86/320793), 31757-80 (26/F55872), 31757-85 (26/F55873), 31757-90 (26/F55874).
Apr 1, 2026
View details →Orthalign, inc
High PriorityActive
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Lot # 25092204BB/ UDI:00810832032434
Apr 1, 2026
View details →Orthalign, inc
High PriorityActive
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Lot # 25091103BB/ UDI: 00810832032427
Apr 1, 2026
View details →Merit medical systems, inc.
High PriorityActive
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
REF:UDI-DI/Lot(Expiration): H965103028011/A:00884450793206/I3105589, I3115469, I3314948, I3343030; H965103028021/A:00884450793213/I2985084, I3235297, I3302100, I3343023; H965103028021/EU:00884450840733/I3254932; H965103028031/A:00884450786215/I2890967, I2909607, I2909610, I2909613, I2922255, I2928443, I2928445, I2973185, I2975817, I2979931, I2979932, I3010126, I3015730, I3015731, I3072562, I3108161, I3115487, I3120008, I3156395, I3161825, I3178917, I3202927, I3236144, I3236147, I3236157, I3236162, I3236164, I3368281; H965103028031/EU:00884450835326/I3219447, I3270828, I3288591; H965103028041/A:00884450786253/I2838431, I2910263, I2910264, I2910265, I2973186, I2975804, I2975805, I2979959, I2979960, I3015758, I3064923, I3064925, I3072563, I3108163, I3120003, I3120006, I3156399, I3165147, I3175748, I3178899, I3208677, I3236145, I3236148, I3236158, I3236163, I3236165, I3312321, I3315961, I3323271, I3347039; H965103028041/EU:00884450835333/I3217180, I3270829, I3302439; H965103028051/A:00884450793220/I2929337, I2997999, I3311219; H965103028051/EU:00884450840740/I3219448, I3270832, I3302440; H965103028061/A:00884450793237/I2920321, I2980492, I3154945, I3254911; H965103028061/EU:00884450835340/I3196140, I3270833, I3312332; H965103028070/A:00884450793244/I3015819, I3113237, I3170179, I3247943, I3288616; H965103028070/EU:00884450840757/I3255305, I3307483; H965103028080/A:00884450793251/I3002021, I306492, I3178919, I3302450, I3343031; H965103028080/EU:00884450840764/I3196137, I3302445, I3334625; H965103028090/A:00884450792353/I2920165, I3103138, I3178922, I3290565; H965103028090/EU:00884450840771/I3196135, I3302441, I3352493; H965103028161/A:00884450793268/I2914680, I2980457), I3098578; H965103028181/A:00884450793282/I2890978, I2902665, I2909617, I2909618, I2929338, I3076856, I3085067, I3098579, I3178915, I3254917, I3255301, I3283028; H965103028191/A:00884450793299/H2936911, I2870746, I2908636, I2909637, I2910257, I2920337, I2927199, I3144031, I3164176, I3219662, I3236146, I3288655, I3368110; H965103028191/EU:00884450835371/I3309111; H965103028201/A:00884450793305/I2973187, I3173621, I3178898), I3236149, I3288573; H965103028211/A:00884450793312/I2909764, I3144033, I3302435, I3343037; H965103028220/A:00884450793329/I2909788, I3394016; H965103028230/A:00884450793336/I2982337, I3044847, I3191920, I3288574, I3334623; H965103028240/A:00884450792360/I2929339, I3002035, I3049565, I3108165, I3254923, I3302451; H965103038181/A:00884450786314/I2890952, I2902661, I2902662
Apr 1, 2026
View details →Navajo manufacturing company
High PriorityActive
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.
UPC: 0-24291-25607-6, UDI-DI: 00024291256076
Apr 1, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Model Number: MAJ-1444. UDI-DI: 04953170355929. Catalog number: N5363530. All Lot/Serial Numbers.
Apr 1, 2026
View details →Straumann usa llc
High PriorityActive
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Catalog Number/Art.: 027.4620; UDI-DI: 07630031713766; Order number (lot): 92465US_12039_00_b00 , 92465US_12040_00_b00 , 92465US_12047_00_b00 , 92465US_12048_00_b00 , 70959US_02227_00_b00 , 94021US_02348_00_b00, 70416US_07543_00_b00 , 91395US_01687_00_b00 , 91545US_03284_00_b00 , 91545US_03285_00_b00 , 71711US_00420_00_b00 , 91853US_06313_00_b00 , 72747US_00247_00_b00;
Apr 1, 2026
View details →Olympus corporation of the americas
High PriorityActive
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Model: 3005; UDI: 00821925035881; Lot Number: All unexpired
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 21602-3 (643/072330, 643/092310), 21602-4 (643/072301, 643/072308), 21602-5 (643/022417, 643/0650, 643/072309), 21602-6 (643/042305, 643/072333), 21602-7 (643/072332, 643/082305), 21602-8 (43/0405, 643/012305), 21603-3 (643/072331, 643/082306), 21603-4 (643/102214, 643/102206, 643/072302, 643/022313, 643/032310), 21603-5 (643/072335, 643/122308), 21603-6 (643/022309, 643/072305, 643/072311, 643/122309), 21603-7 (643/072337, 643/082313), 21603-8 (643/072312, 643/122204). 2. Article Number (Lot Numbers): 21225-4 (768/20894, 26/F65041, 26/F66149, 679/092305, 679/022430, 26/F705141, 26/F72362, 26/F73634), 21225-6 (768/20895, 768/20039, 26/F65042, 26/F66150, 26/F66499, 679/092321, 26/F705161, 679/062459, 26/F70516, 26/F73635), 21225-8 (768/20896, 26/F65635, 26/F66500, 26/F70515), 21225-10 (26/F66497), 21225-12 (26/F66498, 679/012438), 21226-4 (26/F65043, 26/F66152, 26/F66501, 26/F70521, 26/F705211, 679/012412, 679/062306, 679/092306, 768/20897, 768/208978), 21226-6 (26/F35433, 26/F65044, 26/F66502, 26/F70522, 26/F705221, 679/062307, 679/092307, 768/20898), 21226-8 (26/F66503, 679/012413, 768/20045, 768/20899), 21226-10 (26/F66151), 21226-12 (26/F66148, 679/012411). 3. Article Number (Lot Numbers): 21601-5 (643/012302, 643/072323), 21601-6 (643/072326, 770/201904), 21601-7 (643/012303, 643/022308, 643/0647, 643/072315, 643/072327, 643/082303), 21601-8 (643/072328, 643/072329), 21601-10 (643/022312, 643/082301, 643/082302), 21601-12 (26/F70342), 21601-14 (26/F70343), 21601-16 (26/F70344).
Apr 1, 2026
View details →Amo puerto rico manufacturing, inc.
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Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403
Apr 1, 2026
View details →Merit medical systems, inc.
High PriorityActive
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
REF:UDI-DI/Lot: H787103028015/A:00884450794524/I3049562; H787103028025/A:00884450794531I3309371; H787103028031/A:00884450794548/I2929299, I3072553, I3154760, I3175731, I3178921, I3315957; H787103028035/A:00884450786130/I2910259, I2910261, I2910262, I2980545, I2995795, I3021388, I3076851, I3085062, I3219446, I3219454, I3255314, I3288649, I3334618; H787103028041/A:00884450794555/I2909647, I3115465, I3178909, I3236154; H787103028045/A:00884450786161/I3004072, I3015761, I3044845, I3072554, I3108153, I3176646, I3178918, I3213147, I3219456, I3281054, I3334627; H787103028051/A:00884450794562/I2995730, I3072556, I3213145, I3219455, I3288560, I3302443; H787103028055/A:00884450794579/I3178903); H787103028061/A:00884450794586/I2929300, I2995814, I3072557, I3165105, I3207168, I3236155, I3334619; H787103028075/A:00884450794609/I2995817), I3209313, I3270826; H787103028085/A:00884450794623/I2890956, I3072561, I3108155, I3288562, I3302444; H787103028095/A:00884450794630/I2909667, I2929315, I3021151, I3098576), I3219463, I3288581; H787103028165/A:00884450794647/I3049563; H787103028181/A:00884450794661/I2929317, I3178900, I3208675; H787103028185/A:00884450786178/I2927170, I2929318, I2929319, I3002050, I3015762, I3021450, I3049572, I3085060, I3173615, I3178896, I3195157; H787103028191/A:00884450794678/I2909758; H787103028195/A:00884450786185/I2890957, I2929321, I3021395, I3049573, I3076853, I3124837, I3169030, I3213148, I3236141, I3236161, I3302447, I3343042; H787103028205/A:00884450794692/I2927146, I2995766, I3015801, I3044846, I3144026, I3219464, I3288564, I3302448; H787103028215/A:00884450794708/I3178904; H787103028225/A:00884450794715/I3044836, I3108157, I3236142, I3315958; H787103028235/A:00884450842249/I3178905;
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 21116-8 (679/092230), 21117-10 (679/032313, 679/092231), 21118-10 (679/032314, 679/072047, 679/092232). 2. Article Number (Lot Numbers): 21121-6 (679/092236, 679/092329), 21121-8 (679/052226). 3. Article Number (Lot Numbers): 21122-10 (00/0425-02, 00/0825-02, 679/022443, 679/062310, 86/043372), 21122-6 (00/0325-01, 00/0425-01, 679/042340, 679/062334, 679/122269, 86/043366), 21122-8 (00/0325-08, 679/022243, 679/022304, 679/022451, 679/042209, 679/042214, 679/052319, 679/102368, 86/043368). 4. Article Number (Lot Numbers): 21123-4 (00/0810-06, 679/052014, 679/062216), 21124-4 (679/042333, 679/062217, 679/072346), 21127-6 (679/052228), 21128-6 (679/042341).
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
Brand Name: Humeral Head Plate with Angular Stability, with the
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Article Number (Lot Numbers): 211341-10 (26/F63368, 26/F65625, 26/F66904, 26/F669041, 679/012410), 211341-4 (26/F63366, 26/F65626, 26/F656261, 26/F66145, 26/F661451, 26/F66496, 26/F66905, 26/F669051, 26/F73497, 679/012439, 679/022450), 211341-7 (26/F63367, 26/F65627, 26/F66146, 26/F66906, 679/012440), 21134-4 (768/18758, 768/19642), 21134-5 (778/201904), 21135-4 (26/F67801, 768/21382), 21136-4 (26/F65629, 26/F66907, 26/F67802, 26/F70071, 768/21383), 21136-5 (770/101901), 21136-7 (26/F65039, 26/F65630), 21137-4 (26/F65631, 26/F67804, 768/21384), 21137-7 (26/F65040), 21138-4 (26/F65633, 26/F66908, 26/F67806), 21139-4 (26/F65634, 26/F67807, 768/21386).
Apr 1, 2026
View details →Philips ultrasound, inc
High PriorityActive
Philips Mini Multi TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M.
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).
Apr 1, 2026
View details →Philips respironics, inc.
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Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
All Model No.; All UDI; All Serial No.
Apr 1, 2026
View details →Philips ultrasound, inc
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Philips L12-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231; UDI: (01)00884838067851(21)B27H7T, (01)00884838067974(21)B0B0B1, (01)00884838067851(21)B16RRG, (01)00884838067974(21)B0HWBM, (01)00884838067974(21)B0B39M, (01)00884838067851(21)B1N2FG, (01)00884838067851(21)B1DD6B, (01)00884838067851(21)B27GVB, (01)00884838067851(21)B27RQ7, (01)00884838067851(21)B1WT18, (01)00884838067851(21)B1N1JB; Serial No. B107H4, B106RJ, B02RKJ, B0PXC9, B03JZF, B107JF, B27H7T, B0B0B1, B106XL, B10CF6, B14HHX, B10BZF, B04PTM, B16RRG, 0392R5, B1JPC9, B1JQ8W, B0HWBM, B0B39M, B0XK56, B16L5T, B10BQ3, B0J9Q6, B106DF, B105C1, B1N2FG, B10CTM, B01QKF, B10C67, B0FD7B, B0M21H, B0P7ZP, B1DD6B, B0F6F2, B27GVB, B27RQ7, B14CBD, B14J0X, B1WT18, B1N1JB.
Apr 1, 2026
View details →Medline industries, lp
High PriorityActive
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107
Apr 1, 2026
View details →Olympus corporation of the americas
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Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Model: HACF0533; UDI: 00821925036390; Lot Numbers: All unexpired;
Apr 1, 2026
View details →Beckman coulter, inc.
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MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Due to the likely presence of contamination in well(s).
Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
Apr 1, 2026
View details →Philips ultrasound, inc
High PriorityActive
Philips C9-4 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605365021; UDI: N/A; Serial No. 033DZ4.
Apr 1, 2026
View details →I.t.s. gmbh
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Volar Radius Plate with Angular Stability with the
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Article Number (Lot Numbers): 21031-3 (679/042207, 679/032240, 679/0323115, 679/052317, 26/F70606, 679/032253, 643/032501, 643/072503, 643/102501), 21031-5 (43/0015, 643/102201, 643/102201, 679/0323121, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 679/0323120, 643/102201, 643/102201, 643/102201, 643/102201, 679/0323120, 679/0323120), 21032-11 (679/112312), 21032-3 (679/032241, 643/0623, 679/042293, 679/0323122, 679/062367, 679/052318, 643/022501, 643/062501, 643/072501, 643/102502), 21032-5 (679/122136, 679/0323143, 679/042337), 21033-3 (679/062212, 679/022301, 679/042338, 679/022302), 21033-5 (643/0629, 26/F24901, 679/012311), 21034-3 (679/062221, 679/012312, 679/072217, 679/042339), 21034-5 (643/102202, 679/012314, 679/012313), 21035-3 (679/062222, 679/042308, 643/012501, 643/0548), 21036-3 (679/062213, 679/042309, 679/112317),
Apr 1, 2026
View details →Koven technology, inc.
High PriorityActive
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
Apr 1, 2026
View details →Erbe usa inc
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Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Probes may rupture/burst during activation
UDI: 04050147021822/ Lots: WO459860 WO462187 WO462322 WO462390 WO462391 WO462392 WO462393 WO462396 WO462677 WO462678 WO463323 WO463324 WO463325 WO463326 WO463386 WO463387 WO464280 WO464281 WO464282 WO464283 WO464284 WO465059 WO465060 WO465061 WO465062 WO467876 WO467877 WO467878 WO467879 WO468225 WO468226 WO468227 WO468642 WO468643 WO468644 WO468645 WO468647 WO468671 WO468672 WO468673 WO468674 WO469361 WO469362 WO469363 W2459858 W2459958 W2462283 W2463593 W2465596 W2465623 W2465693 W2465768 W2468859 W2470050 W2470051 W2470052 W4465597
Apr 1, 2026
View details →Olympus corporation of the americas
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Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Model: 920005PK; UDI: 00821925036178; Lot Numbers: All unexpired;
Apr 1, 2026
View details →Philips ultrasound, inc
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Philips X7-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605388121, 989605347571, 989605347573; UDI: (01)00884838061729(21)0344RZ; Serial No. 03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9.
Apr 1, 2026
View details →Olympus corporation of the americas
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Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Model: 3006; UDI: 00821925035898; Lot Numbers: All unexpired;
Apr 1, 2026
View details →Philips ultrasound, inc
High PriorityActive
Philips 3D6-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605326521, 989605440872, 989605440871; UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3, (01)00884838067714(21)02RRQX, (01)00884838067714(21)02HD9F; Serial No. 02V8MV, 02Q19C, 02DNGH, 02TWL6, 02P2LF, 031XK6, 02VF0G, 02HJ9Q, 02DNKX, 02BXT7, 02VHQZ, 02TWD3, 02NDCL, 02CBD4, 02RRQX, 02KWQ9, 02HD9F.
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 21311-11 (26/F62573), 21311-15 (26/F65048, 26/F67521), 21311-7 (26/F66165, 26/F67825), 21312-11 (26/F65049, 26/F67826), 21312-15 (26/F66166), 21312-7 (26/F65643, 26/F67827). 2. Article Number (Lot Numbers): 21094-10 (643/032304, 643/082309), 21094-4 (643/0572, 643/0571), 21094-6 (643/112202), 21094-8 (643/012309). 3.Article Number (Lot Numbers): 21093-4 (679/032311, 679/112331), 21093-6 (679/112332).
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
FR.O.H. Calcaneus Repair System with the
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Article Number (Lot Numbers): 21064-60 (679/012318, 679/0722100).
Apr 1, 2026
View details →Straumann usa llc
High PriorityActive
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Catalog Number/Art.: 010.5438; UDI-DI: 07630031773937; Order number (lot): 71315US_00729_01_b00, 91076US_03269_00_b00, 72509US_01048_00_b00, 72839US_00065_00_b00, 39133US_11508_02_b00, 4202CA_00558_00_b00, 72630CA_00109_00_b00;
Apr 1, 2026
View details →Philips ultrasound, inc
High PriorityActive
Philips OMNI III TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605440701, 989605440702, 989605440772, 989803001561; UDI: (01)00884838067585(21)02ZTTT, (01)00884838067585(21)B0X7MD, (01)00884838067585(21)02VWNV, (01)00884838067585(21)02JQPG, (01)00884838067585(21)02PCMT, (01)00884838067585(21)0341PG, (01)00884838067585(21)02QLMQ, (01)00884838067585(21)B0JFCN, (01)00884838067585(21)03C009, (01)00884838067585(21)02Y7HM, (01)00884838067585(21)02VTGK, (01)00884838067585(21)037CHG, (01)00884838067585(21)03G0BB, (01)00884838067585(21)02WH6F, (01)00884838067585(21)02QK2L, (01)00884838067585(21)037F68, (01)00884838067585(21)0344C9, (01)00884838067585(21)037HLM, (01)00884838067646(21)035R8K, (01)00884838067585(21)02JJ0T, (01)00884838067585(21)031LC8, (01)00884838067585(21)039JWQ, (01)00884838067585(21)03436F, (01)00884838067585(21)039PCB, (01)00884838067585(21)02P8GV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)03F770, (01)00884838067585(21)0319LX, (01)00884838067585(21)02DG0D, (01)00884838067585(21)B0JF93, (01)00884838067585(21)03C7Q0, (01)00884838067585(21)039Q2L, (01)00884838067585(21)02YCFD, (01)00884838067585(21)B05DX2, (01)00884838067585(21)02WCTB, (01)00884838067585(21)039PC3, (01)00884838067585(21)035V3H, (01)00884838067585(21)038DX2, (01)00884838067585(21)B0LYR8, (01)00884838067585(21)02CGWH, (01)00884838067585(21)032MLN, (01)00884838067585(21)038LT2, (01)00884838067585(21)03G4GG, (01)00884838067585(21)03435X, (01)00884838067585(21)032MMK, (01)00884838067585(21)B0JFDK, (01)00884838067585(21)02WMD4, (01)00884838067585(21)02JP4Z, (01)00884838067585(21)031LCH, (01)00884838067585(21)02JJ6T, (01)00884838067585(21)039JWV, (01)00884838067585(21)035YQG, (01)00884838067585(21)03C04R, (01)00884838067585(21)02DCH7, (01)00884838067585(21)02D9TH, (01)00884838067585(21)035Q9M, (01)00884838067585(21)031CDK, (01)00884838067585(21)0379BH; Serial No. 02ZTTT, 02DFBP, B0X7MD, 039MMD, 02VWNV, 02JQPG, 02PCMT, 0341PG, 02GR5B, 035PWZ, 02QLMQ, B0JFCN, 03CVTB, 03C009, 02Y7HM, 02VTGK, 037CHG, 03G0BB, 02WH6F, 02QK2L, 038MJ6, 037F68, 038GL7, 0344C9, 037HLM, 035R8K, 02JL01, 02JJ0T, 031LC8, 039JWQ, 035PYK, 03436F, 039PCB, 031HN7, 02P8GV, 039HQ2, B07FFB, 03F770, 035Q9P, 0319LX, 02DG0D, B0JF93, 03C7Q0, 039Q2L, 02YCFD, B05DX2, 02WCTB, 039PC3, 035V3H, 038DX2, B0LYR8, 02CGWH, 032MLN, 035P8R, 038LT2, 03G4GG, 03435X, 032MMK, 02QGKV, B0JFDK, 02VN40, 032FKW, 02WMD4, 02JP4Z, 031LCH, 02JJ6T, 039JWV, 035YQG, 03C04R, 03C6ZH, 02DCH7, 02D9TH, 035Q9M, 031CDK, 0379BH.
Apr 1, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
Apr 1, 2026
View details →Tandem diabetes care, inc.
High PriorityActive
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
Version 7.8.1/ UDI: (01)008500066132625
Apr 1, 2026
View details →Medtronic minimed, inc.
High PriorityActive
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).
MiniMed 780G Model Number: MMT-1884 UDI-DI code: 763000414344 Serial Numbers: NG2445689H NG2445778H NG2455039H NG2461527H NG2461608H NG2471389H NG2471573H NG2472820H NG2473989H NG2480622H NG2481237H NG2488091H NG2489139H NG2489358H NG2493893H NG2494899H NG2496212H NG2496474H NG2497261H NG2499391H NG2499496H NG2500475H NG2500548H NG2501835H NG2502145H NG2502898H NG2507769H NG2507907H NG2508301H NG2508631H NG2508977H NG2511996H NG2513292H NG2521020H NG2522070H NG2523184H NG2530419H NG2531373H NG2531462H NG2531531H NG2532792H NG2533855H NG2535235H NG2535576H NG2537531H NG2538456H NG2540108H NG2541102H NG2541837H NG2543029H NG2544725H NG2548997H NG2550437H NG2570180H NG2570258H NG2570863H NG2576778H NG2579113H NG2579956H NG2580323H NG2580479H NG2583059H NG2583537H NG2586717H NG2589082H NG2590426H NG2603812H NG2603854H NG2604027H NG2611960H NG2612797H NG2614177H NG2617670H NG2617983H NG2629660H NG2635544H NG2636572H NG2637401H NG2642169H NG2644227H NG2644567H NG2647406H NG2647913H NG2648318H NG2649298H NG2656257H NG2656473H NG2657321H NG2657360H NG2658332H NG2659390H NG2659574H NG2697897H NG2697936H NG2698209H NG2698900H NG2705266H NG2706152H NG2710968H NG2712109H NG2714386H NG2718094H NG2723617H NG2724376H NG2724445H NG2742517H NG2742729H NG2742925H NG2742927H NG2745927H NG2748918H NG2748985H NG2749113H NG2749121H NG2749143H NG2750007H NG2750299H NG2751081H NG2751191H NG2752539H NG2752574H NG2753164H NG2753234H NG2753931H NG2754038H NG2760759H NG2760871H NG2761027H NG2761050H NG2761095H NG2761117H NG2761226H NG2761771H NG2762312H NG2762332H NG2772977H NG2773133H NG2773170H NG2773198H NG2773224H NG2773698H NG2774482H NG2774486H NG2774628H NG2775088H NG2775593H NG2775790H NG2775796H NG2776055H NG2776076H NG2776843H NG2777281H NG2777366H NG2777406H NG2777964H NG2778250H NG2778518H NG2791067H NG2810990H NG2811465H NG2851127H NG2852041H NG2852121H NG2852167H NG2852226H NG2852237H NG2852293H NG2852641H NG2852707H NG2853049H NG2853185H NG2853369H NG2853574H NG2853980H NG2854083H NG2854095H NG2854218H NG2854266H NG2868862H NG2869169H NG2869564H NG2870219H NG2870848H NG2871392H NG2871868H NG2872358H NG2872379H NG2873197H NG2879290H NG2880034H NG2880037H NG2880061H NG2880324H NG2892508H NG2909952H NG2910456H NG2910488H NG2910742H NG2910995H NG2911113H NG2911329H NG2911785H NG2911915H NG2912050H NG2912065H NG2912195H NG2912304H NG2912412H NG2912423H NG2912530H NG2912600H NG2912625H NG2912670H NG2912798H NG2916905H NG2917028H NG2917060H NG2917238H NG2917352H NG2917461H NG2917748H NG2917757H NG2917849H NG2917881H NG2918087H NG2918234H NG2918273H NG2918540H NG2918762H NG2918951H NG2919128H NG2919210H NG2921713H NG2921759H NG2921764H NG2921912H NG2921960H NG2922097H NG2922157H NG2922350H NG2922515H NG2922615H NG2922632H NG2922633H NG2922990H NG2923035H NG2923056H NG2923120H NG2923140H NG2923262H NG2923459H NG2923582H NG2923832H NG2923995H NG2924042H NG2924152H NG2941414H NG2941570H NG2941614H NG2941619H NG2941809H NG2941839H NG2941875H NG2942123H NG2942193H NG2942249H NG2942367H NG2942645H NG2942782H NG2943281H NG2943510H NG2943529H NG2943592H NG2951199H NG2951224H NG2951253H NG2951586H NG2951675H NG2951690H NG2951706H NG2951750H NG2951859H NG2952135H NG2952255H NG2952320H NG2952397H NG2952463H NG2952485H NG2952507H NG2952650H NG2953269H NG2953290H NG2953392H NG2953536H NG2953801H NG2953875H NG2953954H NG2953997H NG2954054H NG2954081H NG2954200H NG2954202H NG2955586H NG2955592H NG2955666H NG2955753H NG2955756H NG2955850H NG2955927H NG2955990H NG2955994H NG2956003H NG2956028H NG2956052H NG2956167H NG2956214H NG2956245H NG2956375H NG2956416H NG2956504H NG2956533H NG2956561H NG2956567H NG2956660H NG2956711H NG2956824H NG2956934H NG2956979H NG2960027H NG2960318H NG2960498H NG2960556H NG2960899H NG2960914H NG2961016H NG2961049H NG2961106H NG2961108H NG2961114H NG2961187H NG2961287H NG2961320H NG2961354H NG2961405H NG2961445H NG2961655H NG2961682H NG2961761H NG2961771H NG2961782H NG2961813H NG2961906H NG2961958H NG2961965H NG2961968H NG2961995H NG2962012H NG2962032H NG2968147H NG2968281H NG2968308H NG2968340H NG2968491H NG2968492H NG2968499H NG2968805H NG2968842H NG2968986H NG2969067H NG2969111H NG2969152H NG2969273H NG2969277H NG2969388H NG2969415H NG2969441H NG2969468H NG2969542H NG2969582H NG2969745H NG2980849H NG2980857H NG2980875H NG2980916H NG2981068H NG2981268H NG2981313H NG2981419H NG2981696H NG2981774H NG2981975H NG2981985H NG2982089H NG2982172H NG2982232H NG2982281H NG2982538H NG2982662H NG2982763H NG2982864H NG2982878H NG2982896H NG2982986H NG2983018H NG3001336H NG3001600H NG3001820H NG3001831H NG3001921H NG3002022H NG3002026H NG3002037H NG3002060H NG3002155H NG3002250H NG3002265H NG3002371H NG3002388H NG3002553H NG3002580H NG3002594H NG3002602H NG3002608H NG3002641H NG3002652H NG3002681H NG3002708H NG3002710H NG3002734H NG3002762H NG3002772H NG3002782H NG3002909H NG3002911H NG3002929H NG3002958H NG3002962H NG3002996H NG3003022H NG3003051H NG3003153H NG3010488H NG3010602H NG3010604H NG3039386H NG3039702H NG3039783H NG3039868H NG3039898H NG3039907H NG3040007H NG3040066H NG3040192H NG3040203H NG3040271H NG3040310H NG3040388H NG3040462H NG3040663H NG3040915H NG3040957H NG3041383H NG3041471H NG3041507H NG3041558H NG3041714H NG3041804H NG3041850H NG3041939H NG3041956H NG3042074H NG3042088H NG3042225H NG3042258H NG3042339H NG3042429H NG3042444H NG3042556H NG3042613H NG3042808H NG3042814H NG3042827H NG3042847H NG3043123H NG3043204H NG3043239H NG3043266H NG3043366H NG3049774H NG3049819H NG3049826H NG3049828H NG3049866H NG3049875H NG3049894H NG3049899H NG3049933H NG3049993H NG3050017H NG3050045H NG3050076H NG3050147H NG3050213H NG3050292H NG3050369H NG3050457H NG3050480H NG3050549H NG3050579H NG3050598H NG3050631H NG3050665H NG3050667H NG3050754H NG3050884H NG3050889H NG3050994H NG3051014H NG3051043H NG3051101H NG3051146H NG3051176H NG3051340H NG3051417H NG3051461H NG3051497H NG3051536H NG3051561H NG3051566H NG3051690H NG3051721H NG3052194H NG3052670H NG3052958H NG3053073H NG3053170H NG3053302H NG3053400H NG3053421H NG3054702H NG3054721H NG3055038H NG3055061H NG3056417H NG3056636H NG3070993H NG3074383H NG3074438H NG3074461H NG3074532H NG3074697H NG3075903H NG3075935H NG3076521H NG3076597H NG3078872H UDI-DI code: 763000439859 Serial Numbers: NG2521143H NG2583395H NG2617162H NG2629426H NG2629644H NG2630119H NG2630635H NG2640853H NG2641540H NG2647767H NG2656322H NG2672162H NG2724308H NG2742319H NG2742619H NG2854386H NG2869076H NG2869428H NG2872045H NG2880599H NG2880930H NG2881168H NG2952824H NG2960122H NG2960155H NG2961005H NG2981338H NG2981449H NG2981455H NG2981459H NG2981461H NG2981500H NG2981639H NG3001480H NG3039155H NG3039437H NG3039662H NG3039860H NG3051945H NG3052291H NG3052464H NG3056782H NG3065697H NG3075841H NG3076011H NG3076138H NG3078541H NG3078685H NG3078710H NG3078719H NG3078922H UDI-DI code: 763000545604 Serial Numbers: NG3104959H NG3105146H NG3105159H NG3105212H NG3105241H NG3105341H NG3105343H NG3105380H NG3105436H NG3105450H NG3105460H NG3105485H NG3105487H NG3105501H NG3105595H NG3105755H NG3105794H NG3105819H NG3105823H NG3106011H NG3106032H NG3106131H NG3106145H NG3106161H NG3106258H NG3106267H NG3106273H NG3106359H NG3106396H NG3106549H NG3106577H NG3106695H NG3106726H NG3106755H NG3106763H NG3106767H NG3106788H NG3106808H NG3106873H NG3106884H NG3106891H NG3110328H NG3110411H NG3110486H NG3110492H NG3110494H NG3110495H NG3110511H NG3110513H NG3110558H NG3110617H NG3110642H NG3110676H NG3110679H NG3110736H NG3110738H NG3110782H NG3110804H NG3110808H NG3110867H NG3110918H NG3110938H NG3110964H NG3111009H NG3111048H NG3111082H NG3111184H NG3111212H NG3111224H NG3111246H NG3111256H NG3111368H NG3111392H NG3111579H NG3111627H NG3111647H NG3111662H NG3111680H NG3111755H NG3111779H NG3111798H NG3111831H NG3111838H NG3111930H NG3111939H NG3111969H NG3112000H NG3112010H NG3112032H NG3112081H NG3112117H NG3112175H NG3112244H NG3112246H NG3112249H NG3112303H NG3112355H NG3112385H NG3112766H NG3112778H NG3112971H NG3113130H NG3113153H NG3114006H NG3114030H NG3114124H NG3114181H NG3114185H NG3114186H NG3114233H NG3114301H NG3114333H NG3114371H NG3114497H NG3114553H NG3114596H NG3114721H NG3114736H NG3114840H NG3114882H NG3114900H NG3114949H NG3114974H NG3114988H NG3115020H NG3115692H NG3115702H NG3115739H NG3115747H NG3115802H NG3115822H NG3115823H NG3115826H NG3115827H NG3115840H NG3115843H NG3115863H NG3115935H NG3115937H NG3115953H NG3116008H NG3116077H NG3116121H NG3116129H NG3116206H NG3116237H NG3116241H NG3116970H NG3116982H NG3116987H NG3117144H NG3117299H NG3117306H NG3117314H NG3117316H NG3117391H NG3117404H NG3117413H NG3117443H NG3117539H NG3117634H NG3117686H NG3117691H NG3117734H NG3117785H NG3117822H NG3117863H NG3117883H NG3117885H NG3117989H NG3118174H NG3118214H NG3118254H NG3118272H NG3118329H NG3118447H NG3118644H NG3118819H NG3118835H NG3118915H NG3118955H NG3119076H NG3135728H NG3135954H NG3135974H NG3136141H NG3136250H NG3136547H NG3136655H NG3136680H NG3136764H NG3136791H NG3136842H NG3136862H NG3136916H NG3136925H NG3136955H NG3137000H NG3137021H NG3137046H NG3137362H NG3137381H NG3137401H NG3137402H NG3137442H NG3137479H NG3137502H NG3137560H NG3137583H NG3137817H NG3137849H NG3137868H NG3137877H NG3137907H NG3138055H NG3138145H NG3138149H NG3138179H NG3138409H NG3138451H NG3138471H NG3138526H NG3138539H NG3138542H NG3138552H NG3138609H NG3138637H NG3138648H NG3138668H NG3147283H NG3147620H NG3147735H NG3147837H NG3147857H NG3148221H NG3148360H NG3148751H NG3148767H NG3148777H NG3148871H NG3148878H NG3148891H NG3148924H NG3148956H NG3148962H NG3149022H NG3149054H NG3149087H NG3149473H NG3149538H NG3149647H NG3161707H NG3161714H NG3161766H NG3161862H NG3161918H NG3161938H NG3162101H NG3162468H NG3162470H NG3162511H NG3162577H NG3162855H NG3162911H NG3162916H NG3163024H NG3163045H NG3163132H NG3163188H NG3163613H NG3163620H NG3163771H NG3164131H NG3164221H NG3164373H NG3164473H NG3164587H NG3164702H NG3164784H NG3164820H NG3165546H NG3165639H NG3165715H NG3172447H NG3172573H NG3172630H NG3172652H NG3172693H NG3172828H NG3172844H NG3172856H NG3172922H NG3173061H NG3173132H NG3178735H NG3178793H NG3178853H NG3178912H NG3182547H NG3182624H NG3182663H NG3182680H NG3182878H NG3182981H NG3183239H NG3183428H NG3183441H NG3183476H NG3183569H NG3183575H NG3183654H NG3183696H NG3183815H NG3183817H NG3183859H NG3183875H NG3183963H NG3183993H NG3183998H NG3184183H NG3184196H NG3184692H NG3185372H NG3191595H NG3192231H NG3192385H NG3192497H NG3192506H NG3192578H NG3192700H NG3192919H NG3192935H NG3193003H NG3193098H NG3193172H NG3193227H NG3193230H NG3193609H NG3193727H NG3193738H NG3193995H NG3194168H NG3194356H NG3194396H NG3194530H NG3194608H NG3194620H NG3194724H NG3194785H NG3194887H NG3194896H NG3194901H NG3194953H NG3194993H NG3195071H NG3195116H NG3195190H NG3195300H NG3195335H NG3195473H NG3195494H NG3195524H NG3195696H NG3195730H NG3195736H NG3203111H NG3203266H NG3203334H NG3203410H NG3203565H NG3203578H NG3203653H NG3203752H NG3203780H NG3203812H NG3203917H NG3203979H NG3204329H NG3204481H NG3204564H NG3204650H NG3204655H NG3204929H NG3204992H NG3205227H NG3205301H NG3205427H NG3205710H NG3205768H NG3205794H NG3205833H NG3206024H NG3206110H NG3206192H NG3206262H NG3206304H NG3206345H NG3206448H NG3206542H NG3206595H NG3206611H NG3206619H NG3206712H NG3206718H NG3206721H NG3206780H NG3206791H NG3206846H NG3206847H NG3206868H NG3206869H NG3206913H NG3206919H NG3206921H NG3207325H NG3207421H NG3207527H NG3208290H NG3208311H NG3208324H NG3208375H NG3213347H NG3213451H NG3213461H NG3213526H NG3213616H NG3213666H NG3213670H NG3213822H NG3213899H NG3213978H NG3214139H NG3214147H NG3214301H NG3214690H NG3214742H NG3214775H NG3214819H NG3214853H NG3214856H NG3214975H NG3215004H NG3215019H NG3215103H NG3221640H NG3221971H NG3221990H NG3221998H NG3222045H NG3222288H NG3222465H NG3222512H NG3222598H NG3222745H NG3222793H NG3222795H NG3222949H NG3222976H NG3222998H NG3226231H NG3226270H NG3226301H NG3226312H NG3226323H NG3226373H NG3226379H NG3226385H NG3226459H NG3226540H NG3226579H NG3226898H NG3226926H NG3226960H NG3226961H NG3226971H NG3226973H NG3227901H NG3228247H NG3228272H NG3228358H NG3228552H NG3228560H NG3228635H NG3233852H NG3235153H NG3235890H NG3238541H NG3238888H NG3238964H NG3239023H NG3239043H NG3239125H NG3239221H NG3239270H NG3239274H NG3239300H NG3239308H NG3239327H NG3239363H NG3239488H NG3239492H NG3239602H NG3239675H NG3239687H NG3239815H NG3239953H NG3239971H NG3240062H NG3240166H NG3240255H NG3240281H NG3240315H NG3240489H NG3240513H NG3240604H NG3240775H NG3240806H NG3240875H NG3240947H NG3241083H NG3241102H NG3241106H NG3241208H NG3241220H NG3241482H NG3241491H NG3242131H NG3242195H NG3242323H NG3242337H NG3242347H NG3242379H NG3242403H NG3242464H NG3242668H NG3242671H NG3242903H NG3242959H NG3243100H NG3243321H NG3243324H NG3243330H NG3243381H NG3243433H NG3243445H NG3243474H NG3243606H NG3243645H NG3243659H NG3243700H NG3244115H NG3244136H NG3244824H NG3244889H NG3244988H NG3245066H NG3245231H NG3245232H NG3245242H NG3245286H 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NG3352352H NG3352357H NG3352379H NG3352454H NG3352484H NG3352501H NG3352530H NG3352587H NG3352631H NG3352753H NG3352905H NG3353153H NG3353165H NG3353219H NG3353231H NG3353241H NG3353383H NG3353403H NG3353420H NG3353439H NG3353489H NG3353519H NG3353622H NG3353641H NG3353798H NG3353859H NG3353967H NG3355859H NG3356140H NG3356259H NG3356320H NG3356350H NG3356355H NG3356560H NG3356748H NG3362076H NG3362131H NG3362138H NG3362143H NG3362160H NG3362207H NG3362209H NG3362212H NG3362629H NG3362944H NG3363019H NG3363036H NG3363170H NG3363290H NG3363399H NG3363566H NG3363657H NG3363712H NG3363730H NG3363943H NG3363949H NG3364099H NG3364118H NG3364150H NG3364229H NG3364261H NG3364319H NG3364406H NG3364441H NG3364501H NG3364569H NG3364631H NG3364639H NG3364645H NG3364650H NG3364711H NG3364737H NG3364757H NG3364813H NG3364851H NG3364854H NG3364904H NG3369448H NG3369498H NG3369526H NG3369536H NG3369542H NG3369666H NG3369671H NG3369725H NG3369750H NG3369770H NG3369786H NG3370247H NG3370341H NG3370487H 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NG3452831H NG3452957H NG3453007H NG3453042H NG3453075H NG3453426H NG3453428H NG3453483H NG3453492H NG3554446H NG3554489H NG3554543H NG3554751H NG3560840H NG3560884H NG3569799H NG3570451H UDI-DI code: 763000640095 Serial Numbers: NG3104580H NG3104789H NG3110101H NG3116173H NG3119145H NG3119458H NG3119507H NG3119730H NG3119833H NG3135607H NG3135718H NG3147899H NG3147921H NG3163071H NG3163526H NG3184720H NG3184785H NG3184912H NG3185210H NG3185266H NG3191053H NG3191276H NG3191364H NG3191425H NG3191627H NG3191691H NG3192062H NG3194657H NG3205367H NG3206971H NG3207130H NG3213279H NG3214381H NG3214812H NG3228388H NG3233570H NG3233623H NG3233867H NG3234105H NG3234323H NG3234727H NG3234789H NG3234883H NG3235133H NG3235472H NG3235643H NG3235682H NG3235686H NG3235768H NG3235854H NG3235970H NG3236243H NG3236323H NG3236324H NG3236603H NG3236686H NG3236712H NG3242205H NG3242370H NG3246414H NG3253416H NG3261805H NG3261965H NG3262131H NG3262182H NG3262213H NG3262249H NG3262282H NG3262491H NG3291857H 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NG3456889H NG3456894H NG3456930H NG3457031H NG3457075H NG3457106H NG3457116H NG3457135H NG3457158H NG3457166H NG3457185H NG3457189H NG3457192H NG3457202H NG3457203H NG3457209H NG3457218H NG3457271H NG3457299H NG3457310H NG3457348H NG3457370H NG3457383H NG3457403H NG3457405H NG3457409H NG3457418H NG3457429H NG3457439H NG3457484H NG3457493H NG3457949H NG3457995H NG3458002H NG3458038H NG3458063H NG3458129H NG3458132H NG3458148H NG3458157H NG3458220H NG3458234H NG3458237H NG3458241H NG3458328H NG3458340H NG3458356H NG3458367H NG3458383H NG3458389H NG3458390H NG3458397H NG3458398H NG3458405H NG3458407H NG3458410H NG3458418H NG3458456H NG3458466H NG3458479H NG3458491H NG3458524H NG3458571H NG3458613H NG3458636H NG3458644H NG3458660H NG3458673H NG3458694H NG3458784H NG3458815H NG3458818H NG3458862H NG3458883H NG3458886H NG3458896H NG3458897H NG3458927H NG3458987H NG3459062H NG3459066H NG3459069H NG3459127H NG3459132H NG3459189H NG3459551H NG3459574H NG3459602H NG3459604H NG3459605H NG3459608H NG3459611H NG3459615H NG3459618H NG3459625H NG3459651H NG3459658H NG3459661H NG3459676H NG3459703H NG3459728H NG3459736H NG3459777H NG3459781H NG3459825H NG3459879H NG3459903H NG3459919H NG3459924H NG3459929H NG3459935H NG3459952H NG3459954H NG3459960H NG3459966H NG3459996H NG3460006H NG3460046H NG3460056H NG3460153H NG3460156H NG3460178H NG3460181H NG3460194H NG3460241H NG3460335H NG3460340H NG3460353H NG3460359H NG3460392H NG3460446H NG3460482H NG3460490H NG3460526H NG3460534H NG3460590H NG3460665H NG3460668H NG3460670H NG3460737H NG3460761H NG3460785H NG3460788H NG3460796H NG3460798H NG3460799H NG3460810H NG3460814H NG3460824H NG3460836H NG3460842H NG3460857H NG3460863H NG3460871H NG3460884H NG3460896H NG3460953H NG3460990H NG3461004H NG3461006H NG3461045H NG3461067H NG3461075H NG3461146H NG3461204H NG3461218H NG3461274H NG3461308H NG3461363H NG3461426H NG3461428H NG3461448H NG3461586H NG3461652H NG3461706H NG3461710H NG3461762H NG3461833H NG3461848H NG3461890H NG3461893H NG3461902H NG3462342H NG3462377H NG3462380H NG3462389H NG3462412H NG3462422H NG3462455H NG3462463H NG3462468H NG3462476H NG3462536H NG3462572H NG3462594H NG3462660H NG3462696H NG3462711H NG3462717H NG3462718H NG3462766H NG3463336H NG3463404H NG3463424H NG3463441H NG3463490H NG3463498H NG3463592H NG3463670H NG3463678H NG3463688H NG3464119H NG3464125H NG3464173H NG3464182H NG3464200H NG3464277H NG3464322H NG3464351H NG3464354H NG3464394H NG3464418H NG3464457H NG3464503H NG3464542H NG3464572H NG3464645H NG3464692H NG3464694H NG3464697H NG3464703H NG3464740H NG3464761H NG3464811H NG3464825H NG3464836H NG3464882H NG3464892H NG3464933H NG3464986H NG3464997H NG3465058H NG3465075H NG3465082H NG3465194H NG3465315H NG3465340H NG3465441H NG3465458H NG3465529H NG3465600H NG3465685H NG3465750H NG3465793H NG3466199H NG3466233H NG3466243H NG3466252H NG3466275H NG3466318H NG3466323H NG3466334H NG3466397H NG3466484H NG3466489H NG3466517H NG3466519H NG3466524H NG3466552H NG3466592H NG3466601H NG3466665H NG3466667H NG3466680H NG3466758H NG3466812H NG3466887H NG3466910H NG3466961H NG3466967H NG3467038H NG3467052H NG3467065H NG3467108H NG3467117H NG3467141H NG3467162H NG3467179H NG3467383H NG3467406H NG3467417H NG3467422H NG3467425H NG3467429H NG3467468H NG3467495H NG3467502H NG3467526H NG3467622H NG3467639H NG3467640H NG3467644H NG3467707H NG3467742H NG3467745H NG3467773H NG3467794H NG3467869H NG3467885H NG3467901H NG3468523H NG3468526H NG3470220H NG3470222H NG3470266H NG3470375H NG3470397H NG3470447H NG3470453H NG3470467H NG3470600H NG3470624H NG3470648H NG3470690H NG3470746H NG3470837H NG3470851H NG3470891H NG3470903H NG3470947H NG3470953H NG3470956H NG3471005H NG3471028H NG3471074H NG3471108H NG3471241H NG3471291H NG3471378H NG3471421H NG3471424H NG3471453H NG3471466H NG3471484H NG3471498H NG3471502H NG3471516H NG3471542H NG3471571H NG3471642H NG3471678H NG3471702H NG3471707H NG3471763H NG3471797H NG3472303H NG3472311H NG3472381H NG3472481H NG3472592H NG3472642H NG3472776H NG3472794H NG3472815H NG3472827H NG3472868H NG3472873H NG3472874H NG3472882H NG3472890H NG3472936H NG3473038H NG3473061H NG3473095H NG3473151H NG3473169H NG3473183H NG3473206H NG3473237H NG3473285H NG3473303H NG3473323H NG3473333H NG3473346H NG3473392H NG3473465H NG3473507H NG3473514H NG3473557H NG3473583H NG3473658H NG3473675H NG3473692H NG3473749H NG3473765H NG3473772H NG3473793H NG3473797H NG3473817H NG3473827H NG3473854H NG3473866H NG3474262H NG3474327H NG3474344H NG3474550H NG3474554H NG3474601H NG3474613H NG3474628H NG3474668H NG3474694H NG3474723H NG3474794H NG3474799H NG3474810H NG3474821H NG3474862H NG3474949H NG3474957H NG3475059H NG3475092H NG3475106H NG3475144H NG3475150H NG3475153H NG3475161H NG3475166H NG3475296H NG3475336H NG3475398H NG3475425H NG3475460H NG3475567H NG3475574H NG3475592H NG3475761H NG3475773H NG3475791H NG3475799H NG3475810H NG3475819H NG3475824H NG3475825H NG3475841H NG3475842H NG3475872H NG3475874H NG3475879H NG3475923H NG3475926H NG3475927H NG3475961H NG3475976H NG3475988H 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NG3501590H NG3501625H NG3501678H NG3501705H NG3501742H NG3501775H NG3501805H NG3501810H NG3501856H NG3501870H NG3501883H NG3502018H NG3502039H NG3502075H NG3502083H NG3502087H NG3502123H NG3502162H NG3502231H NG3502239H NG3502242H NG3502292H NG3502349H NG3502366H NG3502382H NG3502383H NG3502402H NG3502444H NG3502445H NG3502476H NG3502478H NG3502530H NG3502538H NG3502547H NG3502569H NG3502576H NG3502584H NG3502598H NG3502604H NG3502608H NG3502617H NG3502620H NG3502690H NG3502693H NG3502696H NG3502702H NG3502708H NG3502738H NG3502750H NG3502846H NG3502924H NG3502936H NG3502943H NG3502987H NG3503046H NG3503134H NG3503168H NG3503181H NG3503203H NG3503211H NG3503225H NG3503235H NG3503242H NG3503262H NG3503294H NG3503305H NG3503732H NG3503733H NG3503738H NG3503744H NG3503756H NG3503776H NG3503785H NG3503797H NG3503804H NG3503813H NG3503817H NG3503820H NG3503824H NG3503826H NG3503835H NG3503841H NG3503879H NG3503888H NG3503893H NG3503911H NG3503915H NG3503943H NG3503951H NG3503957H NG3503967H NG3503989H NG3503998H NG3504022H NG3504042H NG3504053H NG3504066H NG3504070H NG3504330H NG3505336H NG3505339H NG3505346H NG3505360H NG3505369H NG3505373H NG3505396H NG3505424H NG3505444H NG3505448H NG3505452H NG3505460H NG3505477H NG3505537H NG3505538H NG3505546H NG3505555H NG3505568H NG3505589H NG3505644H NG3505660H NG3505684H NG3505718H NG3505719H NG3505785H NG3505988H NG3505989H NG3506000H NG3506005H NG3506008H NG3506014H NG3506020H NG3506035H NG3506072H NG3506096H NG3506098H NG3506111H NG3506155H NG3506178H NG3506247H NG3506248H NG3506282H NG3506288H NG3506305H NG3506312H
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 21301-5 (26/F62569), 21301-7 (26/F62570), 21301-9 (26/F67518), 21301-13 (26/F62568, 26/F67815), 21302-5 (26/F67520), 21302-7 (26/F67821), 21302-9 (26/F62572, 26/F67822), 21302-13 (26/F62571, 26/F67519, 26/F67820). 2. Article Number (Lot Numbers): 21321-7 (26/F54955, 26/F62576), 21321-12 (26/F55883), 21322-7 (26/F55890, 26/F62578), 21322-12 (26/F62577). 3. Article Number (Lot Numbers): 21325-4 (26/F70528, 679/022433, 679/032217, 679/102240, 679/102242, 679/102303), 21325-7 (679/102241, 679/102304).
Apr 1, 2026
View details →Merit medical systems, inc.
High PriorityActive
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
REF:UDI-DI/Lot: FCL-174-00/B:00884450522196/I2362705, I2370091, I2370711, I2370712, I2377840, I2377841, I2391548, I2397290, I2415120, I2417400, I2417401, I2417402, I2428656, I2428657, I2428658, I2428659, I2469204, I2469205, I2469206, I2469207, I2473119, I2485668, I2485669, I2485670, I2485671, I2485672, I2485673, I2485674, I2485675, I2496785, I2496787, I2496790, I2516610, I2516611, I2516612, I2516613, I2516614, I2516615, I2539710, I2539711, I2539713, I2539714, I2539715, I2539717, I2561078, I2561079, I2561081, I2561082, I2573969, I2606642, I2606643, I2606644, I2606645, I2619459, I2621646, I2621647, I2621648, I2621649, I2621650, I2621651, I2621652, I2621653, I2642738, I2642739, I2642740, I2644031, I2644032, I2644033, I2644034, I2644036, I2661872, I2661873, I2661874, I2661875, I2661876, I2661877, I2708121, I2708122, I2708123, I2708124, I2720071, I2720074, I2720075, I2720076, I2720077, I2720078, I2720079, I2729938, I2729939, I2729940, I2729941, I2729942, I2729943, I2729944, I2729945, I2759253, I2759254, I2759255, I2759256, I2759257, I2759258, I2759260, I2759261, I2759268, I2759269, I2781492, I2781493, I2781494, I2781495, I2781496, I2781497, I2781498, I2781499, I2788883, I2788884, I2788885, I2788886, I2788887, I2788888, I2788889, I2788890, I2788891, I2788892, I2810292, I2810293, I2810294, I2810296, I2810297, I2841474, I2841475, I2849305, I2849306, I2854355, I2854356, I2854357, I2860217, I2860218, I2861568, I2861569, I2871785, I2871786, I2871787, I2883689, I2883691, I2890983, I2904247, I2904250, I2927630, I2927631, I2942563, I2942564, I2942565, I2942566, I2942567, I2942568, I2942569, I2942570, I2942571, I2942667, I2942669, I2988895, I2988896, I2988897, I3013245, I3013246, I3075993, I3075994, I3075995, I3075996, I3075997, I3083308, I3083309, I3083310, I3083312, I3083314, I3083317, I3098214, I3098256, I3127468, I3138237, I3138238, I3138239, I3138240, I3138241, I3138242, I3159773, I3159774, I3159776, I3159777, I3186218, I3257331
Apr 1, 2026
View details →Olympus corporation of the americas
High PriorityActive
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Model: PK-CF0533; UDI: 00821925035867; Lot Numbers: All unexpired;
Apr 1, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
Apr 1, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
Apr 1, 2026
View details →Philips ultrasound, inc
High PriorityActive
Philips OMNI II TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.
Apr 1, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
Apr 1, 2026
View details →Philips ultrasound, inc
High PriorityActive
Philips X3-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605440742, 989603002321, 989605388101, 989605440741; UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0, (01)00884838067615(21)02ZWBH, (01)00884838067615(21)02GP3C, (01)00884838067615(21)03DTL6, (01)00884838067615(21)02JK1H, (01)00884838067615(21)02VMJ6, (01)00884838067615(21)035Z89, (01)00884838067615(21)031C21, (01)00884838067615(21)02JL3W, (01)00884838067615(21)03C066, (01)00884838067615(21)02JK8D; Serial No. 033TVZ, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, 02JK8D.
Apr 1, 2026
View details →Philips respironics, inc.
High PriorityActive
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
All Model No.; All UDI; All Serial No.
Apr 1, 2026
View details →Carefusion 303, inc.
High PriorityActive
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
Catalog Number: 8015 UDI-DI codes: 10885403210747 10885403210754 10885403210891 10885403212048 10885403222108 10885403224614 10885403515231 10885403516023 10885403519215 10885403519284 10885403519291 10885403801518 10885403801532 10885403801549 Serial Numbers: 12360968 12360983 12360985 12360986 12360987 12360988 12360989 12360990 12360991 12360992 12360993 12360994 12360995 12360996 12360997 12360998 12360999 12361000 12361001 12361002 12361003 12361004 12361005 12361006 12361008 12361010 12361013 12361017 12361018 12361019 12361020 12361021 12361022 12361024 12361026 12361027 12361028 12361029 12361030 12361031 12383470 12383471 12383472 12386884 12386885 12388269 12389653 12389660 12389680 12389683 12389691 12389698 12389715 12389727 12389730 12389734 12389738 12389740 12389741 12390061 12390104 12390107 12390118 12390133 12390155 12390184 12390187 12390199 12390219 12390236 12390239 12390257 12390258 12390271 12390274 12390290 12390293 12390300 12390301 12390302 12390558 12390560 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Apr 1, 2026
View details →Ge medical systems, llc
High PriorityActive
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
HIBC: +B681J02000; E85101LA: IMB-22-013 IMB-24-013 IMB-23-006 IMB-24-001 IMB-24-016 IMB-24-018 IMB-24-007 IMB-21-001 IMB-23-004 IMB-24-015 IMB-22-014 IMB-22-011 IMB-21-008 IMB-22-010 IMB-23-003 IMB-22-002 IMB-16-005 IMB-16-002 IMB-17-007 IMB-21-003 IMB-16-003 IMB-18-006 IMB-16-006 IMB-19-014 IMB-23-007 IMB-19-011 IMB-24-011 IMB-15-001 IMB-24-009 IMB-20-005 IMB-19-009 IMB-15-003 IMB-18-007 IMB-17-011 IMB-18-003 IMB-19-003 IMB-17-006 IMB-20-004 IMB-21-005 IMB-21-006 IMB-20-012 IMB-22-004 IMB-17-008 IMB-20-022 IMB-19-019 IMB-18-004 IMB-17-012 IMB-19-008 IMB-15-004 IMB-16-004 IMB-17-005 IMB-18-002 IMB-18-005 IMB-18-010 IMB-19-005 IMB-15-002 IMB-17-009 IMB-17-010 IMB-24-012 IMB-17-002 IMB-20-016 IMB-22-007 IMB-24-002 IMB-20-010 IMB-22-005 IMB-22-017 IMB-24-021 IMB-19-002 IMB-24-017 IMB-20-021 IMB-19-007 IMB-24-014 IMB-24-004 IMB-24-020 IMB-19-013 IMB-20-009 IMB-24-006 IMB-20-008 IMB-24-023 IMB-24-022 IMB-18-009 IMB-19-001 IMB-19-004 IMB-19-006 IMB-19-010 IMB-19-016 IMB-22-001 IMB-22-012 IMB-22-016 IMB-22-018 IMB-17-003 IMB-24-005 IMB-16-007 IMB-22-015 IMB-24-003 IMB-20-002 IMB-20-003 IMB-20-017 IMB-20-018 IMB-20-019 IMB-21-002 IMB-21-004 IMB-22-003 IMB-22-008 IMB-22-009 IMB-20-011 IMB-20-020; E85101LP: IMB-25-005 IMB-21-007 IMB-25-007 IMB-25-008 IMB-20-001 IMB-20-013 IMB-25-012 IMB-25-009 IMB-25-006 IMB-21-009 IMB-25-013 IMB-25-010 IMB-19-012 IMB-25-001 IMB-25-004 IMB-24-024 IMB-25-023 IMB-25-003
Apr 1, 2026
View details →Philips ultrasound, inc
High PriorityActive
Philips S4-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605458221, 989605458222, 989605477101; UDI: (01)00884838085183(21)B25VV3, (01)00884838085183(21)B21XVK, (01)00884838085183(21)B1ZJVG, (01)00884838085183(21)B2D31R, (01)00884838085183(21)B21XXK, (01)00884838085183(21)B25VX0, (01)00884838085183(21)B21Y07, (01)00884838085183(21)B21Y6L, (01)00884838085183(21)B21XYW, (01)00884838085183(21)B1RCNL, (01)00884838074231(21)B21Y64, (01)00884838074231(21)B21YF6, (01)00884838085183(21)B2D34Z, (01)00884838085183(21)B1RCVN, (01)00884838085183(21)B1W8DH, (01)00884838085183(21)B21XTP, (01)00884838085183(21)B21XXQ, (01)00884838085183(21)B25VWD, (01)00884838085183(21)B2Y9PD, (01)00884838085183(21)B2Y9W3, (01)00884838085183(21)B1RCZK, (01)00884838086579(21)B2C76J, (01)00884838085183(21)B2D30D, (01)00884838085183(21)B2792J, (01)00884838085183(21)B2D36X, (01)00884838085183(21)B278QM, (01)00884838085183(21)B21Y7X, (01)00884838085183(21)B1ZJVN, (01)00884838085183(21)B1RCRC, (01)00884838074231(21)B1RCWC, (01)00884838074231(21)B1RCQL, (01)00884838074231(21)B1RCMH, 010088483808518321B2D2RX, (01)00884838086579(21)B2C768, (01)00884838085183(21)B2D2DX, (01)00884838085183(21)B21Y85, 010088483808518321B279D9, (01)00884838085183(21)B1RCW9, (01)00884838085183(21)B1RCNG, (01)00884838085183(21)B21XRB, (01)00884838085183(21)B1RD54; Serial No. B25VV3, B21XVK, B1ZJVG, B2D31R, B21XXK, B25VX0, B21Y07, B21Y6L, B21XYW, B1RCNL, B21Y64, B21YF6, B2D34Z, B1RCVN, B1W8DH, B21XTP, B21XXQ, B25VWD, B2Y9PD, B2Y9W3, B1RCZK, B2C76J, B2D30D, B2792J, B2D36X, B278QM, B21Y7X, B1ZJVN, B1RCRC, B1RCWC, B1RCQL, B1RCMH, B2D2RX, B2C768, B2D2DX, B21Y85, B279D9, B1RCW9, B1RCNG, B21XRB, B1RD54.
Apr 1, 2026
View details →Olympus corporation of the americas
High PriorityActive
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Model: 920000PK; UDI: 00821925038080; Lot Numbers: All unexpired;
Apr 1, 2026
View details →Merit medical systems, inc.
High PriorityActive
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
REF:UDI-DI/Lot(Expiration): DC01455550/C:00884450697870/H2600169; DC21452419/C:00884450697900/H2659228: DC21452419-NE5/C:00884450697894/H3249278): DC21452823/C /H2600164, H2628890; DC21452823-NE5/C:00884450697917/H2990807: DC21453227/C/H2630602; DC21454035/C:00884450697962/H2628887: DC21455550/C:00884450697979/H2630553, H2659229
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 21604-6 (643/052301, 643/0652, 643/092201), 21604-9 (643/032311, 643/062308, 643/062309, 643/112310, 643/122201). 2. Article Number (Lot Numbers): 21605-11 (643/072314, 643/102207), 21605-6 (643/0654, 643/072306, 643/072316, 643/072338, 643/102208, 643/102212, 643/102217, 643/112306, 643/122202), 21605-9 (643/0643, 643/0662, 643/072307, 643/072339, 643/112309, 643/122203). 3. Article Number (Lot Numbers): 21105-6 (86/876787), 21105-8 (86/876788). 4. Article Number (Lot Numbers): 21104-4 (679/052234, 679/082305, 86/036334), 21104-5 (679/0722101, 679/082306, 86/036335), 21104-6 (679/012307, 86/876760), 21104-7 (679/082307, 86/036336, 86/876781), 21104-8 (679/082308, 86/876783), 21104-9 (86/876904). 5. Article Number (Lot Numbers): 21101-5 (86/876637), 21101-6 (679/121605, 00/1105-12, 26/F41923, 86/876638, 86/903610), 21101-7 (770/201905, 00/0518-06, 679/042303, 86/876640), 21101-8 (86/876721, 679/062224), 21101-9 (679/122264, 86/876727), 21101-11 (86/876633), 21101-13 (86/876635). 6. Article Number (Lot Numbers): 21102-6 (770/201905). 7. Article Number (Lot Numbers): 21103-8 (679/092216), 21103-9 (679/062215, 86/876758), 21103-10 (679/092219, 86/876741), 21103-11 (679/062214), 21103-12 (86/876743), 21103-13 (679/022303, 86/876745).
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 37351-10-N (18/240314, 679/122205), 37351-12-N (18/200330, 18/943977, 26/F65544, 679/032401, 679/052417, 679/122261), 37351-14-N (18/201331, 18/511504, 18/944978, 26/F65545, 679/032402, 679/032514, 679/052244, 679/052418, 679/052516, 679/072520), 37351-16-N (18/202332, 18/521505, 18/945979, 26/F65163, 679/032423, 679/032504, 679/052201, 679/062466, 679/062504, 679/072521, 679/122251), 37351-18-N (18/203333, 18/531506, 18/946980, 18/971215, 26/F65546, 679/022329, 679/022516, 679/032430, 679/062206, 679/062505, 679/072522), 37351-20-N (18/231334, 18/541507, 18/952981, 26/F65164, 26/F65547, 679/032431, 679/062230, 679/072501, 679/122202), 37351-22-N (18/233335, 18/953982, 26/F65548, 679/062233, 679/092111, 679/122210), 37351-24-N (18/238336, 18/956983, 26/F65549, 679/042415, 679/072203, 679/112242), 37351-26-N (18/204337, 18/947984, 26/F65166, 26/F65550, 679/022330, 679/042416, 679/062207), 37351-28-N (18/234338, 18/954985, 26/F65551, 679/022331, 679/042423, 679/072204), 37351-30-N (18/205339, 18/948986, 26/F65552, 679/042424, 679/072205, 679/122209), 37351-32-N (18/235340, 18/955987, 26/F65553, 679/042425, 679/062234), 37351-34-N (18/206341, 18/491108, 26/F65554, 679/012306, 679/042426, 679/062208), 37351-36-N (18/239342, 18/571109, 18/571503, 26/F65555, 679/022324, 679/052401, 679/062209), 37351-38-N (18/230679, 18/501110, 18/862696, 679/052402, 679/122252), 37351-40-N (147/15088L, 18/207343, 18/506128, 18/511111, 679/052411), 37351-42-N (18/581112, 679/032515), 37351-44-N (18/591113, 679/022511), 37351-46-N (18/601114), 37351-48-N (18/611115, 679/032517), 37351-50-N (18/513248, 18/621116, 18/912703, 679/032518, 679/062508), 37351-55-N (18/652407, 679/032519), 37351-60-N (18/662408), 37351-65-N (679/022512, 679/052236), 37351-70-N (18/631117, 679/052237), 37351-75-N (18/641118, 679/052238), 37351-80-N (679/052239, 679/072406), 37351-85-N (679/052240). 2. Article Number (Lot Numbers): 21241-5 (770/201905), 21241-7 (770/201906), 21242-7 (770/201901), 21243-10 (770/201901), 21244-9 (770/201905).
Apr 1, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers.
Apr 1, 2026
View details →Erbe usa inc
High PriorityActive
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Probes may rupture/burst during activation
UDI: 04050147021846/ Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 32151-6 (18/408462, 18/500495, 18/691266), 32151-8 (18/408866, 18/531370), 32151-9 (18/351668, 18/541373, 18/741269), 32151-10 (18/408986, 18/551374), 32151-11 (18/371670, 18/561375), 32151-12 (18/409087, 18/571376, 18/771272), 32151-13 (18/581377), 32151-14 (18/409289, 18/591378, 18/791274), 32151-15 (18/409390), 32151-16 (18/409491), 32151-18 (18/821277), 32151-20 (18/831278). 2. Article Number (Lot Numbers): 21505-4 (86/350493, 86/677353), 21506-4 (86/642718, 86/677157). 3. Article Number (Lot Numbers): 21507-4 (26/F65050), 21508-4 (26/F63934, 86/677180). 4. Article Number (Lot Numbers): 21517 (26/F66911). 5. Article Number (Lot Numbers): 21502 (86/677136), 21503-4 (86/337934), 21503-6 (86/868870), 21503-8 (26/F63936), 21503-10 (86/337896, 86/677146), 21504-6 (26/F63364, 86/868885), 21504-8 (26/F63365), 21504-10 (86/642711, 86/677154). 6. Article Number (Lot Numbers): 21513-3 (86/677385), 21513-5 (86/677389), 21514-3 (26/F63935), 21514-5 (86/642722, 86/677183, 86/869183). 7. Article Number (Lot Numbers): 37151-5 (18/561228), 37151-8 (18/166019), 37151-9 (18/625633), 37151-10 (18/626634), 37151-12 (18/628636, 18/671232), 37151-13 (18/166423), 37151-15 (18/206189), 37151-16 (18/132035, 18/691234), 37151-18 (18/142036), 37151-24 (18/167068, 18/172039), 37251-8 (18/421197), 37251-9 (18/591223), 37251-11 (18/619644), 37251-12 (18/620645, 18/962052), 37251-13 (18/521703), 37251-14 (18/531704, 18/951141), 37251-16 (18/002056, 18/031952, 18/623648, 18/971143), 37251-20 (18/571708, 26/F61731).
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90. 6. Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200. 7. Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32. 8. Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90. 9. Curved Plate; Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20. 10. Posterior Column Plate, Left; Article Numbers: 212121-6. 11. Posterior Column Plate, Right; Article Numbers: 212131-6. 12. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-SM. 13. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-LA. 14. Posterior Wall Plate, Extended, Right; Article Numbers: 212111-LA, 212111-SM. 15. Posterior Wall Plate, Left; Article Numbers: 212141-7, 212141-8. 16. Posterior Wall Plate, Right; Article Numbers: 212151-7, 212151-8. 17. PRS Plate; Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7. 18. Quadrilateral Buttress Plate; Article Numbers: 21208-13, 21209-13. 19. Quadrilateral Buttress Plate; Article Numbers: 21208-11, 21209-11. 20. Rim Plate, Left; Article
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 21218-16 (679/112166, 679/122229, 679/122230, 679/122304), 21219-16 (679/012441, 679/062456, 679/0624561, 679/112167, 679/122228). 2. Article Number (Lot Numbers): 21218-14(679/032417, 679/102231, 679/112158, 679/112164, 679/122231), 21219-14 (679/012505, 679/112159, 679/112165, 679/122227, 679/122305). 3. Article Number (Lot Numbers): 21216-10 (679/032501, 679/062453, 679/072276, 679/072510, 679/092203, 679/092401, 679/112168, 679/112409, 679/122270), 21216-12 (679/032503, 679/062344, 679/062454, 679/072277, 679/092204, 679/112170, 679/112413, 679/122271), 21217-10 (679/032502, 679/062346, 679/072278, 679/092402, 679/092404, 679/102216, 679/112169, 679/112423), 21217-12 (679/022238, 679/062345, 679/072513, 679/092403, 679/112171, 679/122407, 679/122426). 4. Article Number (Lot Numbers): 30591-36 (18/922090), 30591-70 (18/231539, 18/775273), 30591-75 (18/751307), 30591-80 (18/777295), 30591-85 (18/301308), 30591-90 (18/311309). 5. Article Number (Lot Numbers): 37422-12-N (18/145897, 18/461842), 37422-14-N (18/215281, 679/032001, 679/062320, 679/092355, 679/122326), 37422-16-N (679/052229, 679/052307, 679/102214, 679/102306, 679/122329), 37422-18-N (18/240520, 18/452529, 18/473354, 679/052316, 679/102215, 679/102337, 679/122330), 37422-20-N (679/0323147, 679/072306, 679/102211, 679/102338, 679/122331), 37422-22-N (18/092876, 18/543636, 679/012406, 679/062361, 679/072312, 679/102212, 679/102348), 37422-24-N (679/012407, 679/052333, 679/072313, 679/102349), 37422-26-N (679/012435, 679/062316, 679/072322, 679/102353), 37422-28-N (18/192499, 679/012422, 679/032211, 679/062317, 679/062323, 679/072323, 679/102361), 37422-30-N (18/217289, 679/012436, 679/032212, 679/0323142, 679/072324, 679/102354), 37422-32-N (18/218290, 679/012437, 679/052335, 679/052337, 679/072329, 679/112306), 37422-34-N (18/031830, 18/219291, 679/012446, 679/062337, 679/062341, 679/072330, 679/112318), 37422-36-N (18/220292, 18/240540, 18/734742, 679/012447, 679/042317, 679/042321, 679/062003, 679/072334, 679/102361), 37422-38-N (18/105881, 18/221293, 18/362296, 18/412482, 679/012243, 679/022407, 679/052331, 679/052334, 679/072349, 679/112323), 37422-40-N (18/052830, 18/222294, 18/240538, 18/493069, 18/736744, 679/022401, 679/032310, 679/042302, 679/072354, 679/112329), 37422-42-N (18/053831, 18/081544, 18/223295, 18/364298, 18/733745, 679/022402, 679/062371, 679/082304, 679/112330), 37422-44-N (18/054832, 18/224296, 18/365299, 18/737746, 18/781832, 679/022412, 679/042331, 679/042345, 679/082314, 679/112335), 37422-46-N (18/052578, 18/225314, 18/366300, 18/738747, 679/022419, 679/042313, 679/042318, 679/082319, 679/112336), 37422-48-N (18/056834, 18/226315, 679/022423, 679/052324, 679/052328, 679/072316, 679/092314, 679/112337), 37422-50-N (18/227316, 18/740748, 679/022436, 679/042336, 679/052314, 679/092342, 679/112338), 37422-55-N (18/113882, 18/368302, 679/032215, 679/052336, 679/062309, 679/092322, 679/112324), 37422-60-N (18/229318, 18/240517, 18/927095, 28/33034, 679/032403, 679/062349, 679/062351, 679/092325, 679/122307), 37422-65-N (18/118884, 18/230319, 18/271754, 18/743749, 18/761192, 28/35846, 679/032216, 679/072303, 679/092326, 679/122308), 37422-70-N (679/102213, 18/744750, 18/893916, 679/062368, 679/092338, 679/102213, 679/122309), 37422-75-N (18/122888, 18/231839, 679/072304, 679/122306), 37422-80-N (679/122254, 18/124887, 679/062352, 679/122320), 37422-85-N (18/056936, 18/271837, 679/012256, 679/092339), 37422-90-N (18/050600, 18/321273, 679/092340), 37422-95-N (18/130891, 679/092341), 37422-100-N (18/132892, 18/341607, 679/102403), 37422-105-N (679/102404), 37422-110-N (18/136894, 18/371843, 679/092337), 37422-115-N (18/138895, 18/391845, 679/012262), 37422-120-N (18/140896, 679/092349), 37592-18 (679/072351), 37592-20 (18/831792, 18/252862), 37592-22 (18/172773, 679/072356), 37592-24 (679/082301), 37592-26 (18/182774, 679/082303), 37592-28 (679/012140, 679/082310), 37592-30 (18/112775, 679/082317), 37592-32 (679/082312), 37592-34 (18/192863, 679/082313), 37592-36 (679/082318), 37592-38 (679/092308), 37592-40 (679/052116, 679/072314), 37592-42 (679/092310), 37592-46 (18/092772, 679/092312), 37592-48 (679/052118, 679/092313), 37592-50 (679/092343), 37592-54 (679/072315), 37592-56 (18/721587), 37592-58 (679/092334), 37592-60 (679/042213, 679/072325, 679/092345), 37592-65 (679/072331), 37592-70 (679/042289, 679/072340, 679/092353), 37592-75 (18/429442, 679/092351), 37592-80 (679/052204, 679/072341, 679/092335), 37592-85 (679/042291, 679/072342, 679/092354), 37592-90 (679/042292, 679/092352). 6. Article Number (Lot Numbers): 31851-60 (18/373463, 18/813133), 31851-65 (18/374464), 31851-70 (18/375465), 31851-75 (18/376467), 31851-80 (18/125212, 18/377468, 18/431563, 18/867967), 31851-85 (18/044945, 18/378469, 18/441564), 31851-90 (18/045946, 18/343266, 18/451565), 31851-95 (18/046947, 18/128224, 18/379470, 18/461566), 31851-100 (18/129225, 18/471567, 18/821469, 18/860968), 31851-105 (18/380471), 31851-110 (18/901298, 18/387472), 31851-115 (18/381473, 18/048949), 31851-120 (18/049950, 18/133227, 18/511577, 18/862970), 31851-125 (18/050951, 18/347474, 18/521578), 31851-130 (18/051952, 18/344368, 18/531579), 31851-135 (18/382475, 18/541580), 31851-140 (18/052953, 18/551777, 18/863971), 31851-145 (18/054954, 18/137229, 18/345351, 18/561779), 31851-150 (18/138260, 18/191042, 18/346352, 18/571780, 18/797898), 31851-155 (18/201043, 18/384476), 31851-160 (18/062955, 18/799900, 18/866972), 31851-165 (18/063956, 18/211045, 18/385477), 31851-170 (18/141230, 18/221046, 18/348353), 31851-175 (18/064957, 18/142263, 18/386398), 31851-180 (18/065958, 18/143264, 18/388399), 31851-185 (18/389400), 31851-190 (18/066959, 18/390401), 31851-195 (18/067960, 18/391478), 31851-200 (18/013266, 18/392479), 31854-60 (18/393482), 31854-65 (18/394499, 18/691605), 31854-70 (18/070983, 18/395500), 31854-75 (18/071984, 18/396501), 31854-80 (18/072985, 18/397502, 18/731608, 18/871960), 31854-85 (18/149247, 18/240529, 18/741609, 18/872961), 31854-90 (18/150280, 18/398503, 18/751610, 18/873962), 31854-95 (18/399504, 18/761611, 18/874963), 31854-100 (18/400505, 18/771612, 18/868964), 31854-105 (18/401506), 31854-110 (18/073986, 18/869965), 31854-115 (18/074987, 18/402507, 18/801615), 31854-120 (18/403508, 18/870966), 31854-125 (18/404509, 18/821617), 31854-130 (18/075988, 18/405366, 18/831618), 31854-135 (18/076989, 18/406510), 31854-140 (18/407369, 18/851693), 31854-145 (18/408370, 18/861706), 31854-150 (18/160285, 18/409371, 18/871704), 31854-155 (18/410511), 31854-160 (18/1622951, 18/411372, 18/862761, 18/891708), 31854-165 (18/163286, 18/412512), 31854-170 (18/164296, 18/413513), 31854-175 (18/079992, 18/414514), 31854-180 (18/080993, 18/415515), 31854-185 (18/081994, 18/416373, 18/808929), 31854-190 (18/082995), 31854-195 (18/083996, 18/961715), 31854-200 (18/084997, 18/417516). 7. Article Number (Lot Numbers): 32351-10 (18/019937, 18/208200, 18/731287, 679/052205, 679/122249), 32351-12 (18/020938, 18/209211, 18/741316, 679/062203, 679/102243), 32351-14 (18/210212, 18/501230, 18/761312, 679/012324, 679/032524, 679/042419, 679/062225, 679/082501, 679/122207), 32351-16 (18/022940, 18/211212, 18/771313, 679/022311, 679/022533, 679/032525, 679/042421, 679/072201, 679/092501, 679/122204), 32351-18 (18/212213, 18/781322, 18/801041, 679/022312, 679/032526, 679/042427, 679/072202, 679/102501, 679/122208), 32351-20 (18/024942, 18/181975, 18/213214, 18/791323, 679/032527, 679/042428, 679/102502, 679/112225), 32351-22 (18/025943, 18/214215, 18/801324, 18/8013241, 18/821061, 679/052219, 679/112235), 32351-24 (18/026988, 18/215216, 18/811325, 18/8113251, 18/831062, 679/052206, 679/102239), 32351-26 (18/027989, 18/216217, 18/821326, 18/841063, 679/052202, 679/052407, 679/112236), 32351-28 (18/028990, 18/217218, 18/8313271, 679/052220, 679/102235), 32351-30 (18/029991, 18/218219, 18/841314, 679/062205, 679/122260), 32351-32 (18/219220, 18/301035, 18/851315, 18/8513151, 679/012303, 679/052203), 32351-34 (18/220221, 18/311041, 18/861328, 18/961089, 679/052243, 679/112229), 32351-36 (18/230222, 18/411090, 679/052221, 679/112241), 32351-38 (18/131369, 18/1313691, 18/221226, 18/321091, 26/F66144, 679/052207, 679/102247), 32351-40 (18/222223, 18/331092, 679/052208, 679/122243), 32351-42 (18/223224, 18/341093, 18/871329, 18/8713291, 679/112214), 32351-44 (18/351094, 18/881330, 18/8813301, 18/921138, 679/052209, 679/112211), 32351-46 (18/225227, 18/361095, 18/891331, 18/8913311, 18/931313, 679/042217, 679/112215), 32351-48 (18/226228, 18/371096, 679/052210, 679/122244), 32351-50 (18/227229, 18/381097, 18/941314, 679/012304, 679/052211), 32351-55 (18/391098, 18/901332, 18/951142, 18/951315, 679/042218, 679/112237), 32351-60 (18/229231, 18/401099, 18/961316, 679/042283, 679/122250), 32351-65 (18/981144, 679/022326, 679/042284), 32351-70 (18/236233), 32351-75 (18/237234, 679/022328), 32351-80 (18/461103, 679/042286), 32351-85 (18/431104), 32352-16 (679/022406, 679/072207, 679/122427), 32352-18 (679/012501, 679/022344, 679/052182), 32352-20 (18/670753, 679/012453, 679/012504, 679/022345, 679/052184, 679/052311), 32352-22 (18/237340, 679/012454, 679/022346, 679/022506, 679/062101, 679/072208, 679/122003), 32352-24 (18/238437, 18/672755, 679/022404, 679/032379, 679/032528, 679/052312, 679/062102, 679/072209, 679/122424), 32352-26 (18/239357, 18/673756, 679/022352, 679/022405, 679/032512, 679/052313, 679/072210, 679/122416), 32352-28 (18/240358, 18/674757, 679/022411, 679/032267, 679/032324, 679/032529, 679/052303, 679/072211, 679/122418), 32352-30 (18/675758, 18/950241, 679/022417, 679/022513, 679/032325, 679/052304, 679/072213, 679/102414, 679/102513), 32352-32 (18/242360, 18/676759, 679/022418, 679/032323, 679/032530, 679/052305, 679/072214, 679/122421), 32352-34 (18/243361, 18/677760, 679/022426, 679/022514, 679/032326, 679/052301, 679/072280, 679/102401), 32352-36 (18/244362, 18/678761, 679/032327, 679/032531, 679/042274, 679/052302, 679/072282, 679/122422), 32352-38 (18/245363, 18/679762, 679/022428, 679/0323112, 679/032392, 679/032513, 679/072283, 679/112502, 679/122413), 32352-40 (18/246364, 18/680763, 679/012506, 679/022438, 679/032268, 679/032375, 679/042342, 679/072112, 679/072285, 679/112505, 679/122419), 32352-42 (18/247365, 18/681764, 679/012507, 679/012508, 679/032347, 679/042343, 679/062246), 32352-44 (18/248366, 18/682765, 679/012217, 679/012503, 679/032339, 679/062247), 32352-46 (18/249367, 18/683766, 18/819818, 679/012218, 679/022526, 679/032371, 679/042332, 679/062249, 679/072294, 679/102402, 679/122501), 32352-48 (18/250368, 679/022444, 679/022505, 679/032372, 679/062251, 679/102180), 32352-50 (18/251369, 18/685768, 679/012509, 679/022452, 679/032364, 679/042329, 679/062253, 679/072295, 679/112434), 32352-55 (18/252370, 18/686769, 679/022504, 679/032376, 679/062255, 679/072296, 679/072297, 679/122401, 679/122504), 32352-60 (18/253438, 18/687770, 679/012222, 679/022527, 679/032328, 679/062257, 679/072298), 32352-65 (18/254460, 18/688798, 679/022457, 679/022520, 679/032343, 679/062259), 32352-70 (18/255371, 18/823821, 679/032344, 679/032408, 679/042316, 679/062261, 679/082201), 32352-75 (18/256429, 679/022522, 679/032398, 679/032399, 679/032409, 679/062263), 32352-80 (18/257430, 679/022523, 679/0323104, 679/0323107, 679/032410, 679/062265), 32352-85 (679/0323109, 679/0323113, 679/062267), 32352-90 (679/0323138, 679/0323141, 679/062268), 32352-95 (679/0323146, 679/0323148, 679/062271), 32352-100 (679/012230, 679/032266, 679/032411, 679/042301, 679/062273), 32352-105 (679/032412, 679/032509, 679/042311, 679/062275), 32352-110 (679/032413, 679/032521, 679/042312, 679/062277), 32352-115 (679/032418, 679/042319, 679/062279), 32352-120 (679/032419, 679/042320, 679/062281), 32455-18 (18/371232), 32455-20 (18/892124), 32455-22 (18/391234, 18/434375, 679/032395), 32455-24 (18/401235, 18/435376, 26/F62579, 679/032387, 679/032396, 679/092502), 32455-26 (18/411236, 18/436377, 679/032397, 679/092503), 32455-28 (18/437378, 679/032345), 32455-30 (18/256241, 679/032346, 679/032388), 32455-32 (18/438380, 18/441239, 26/F62581, 679/032384), 32455-34 (18/440381, 18/451240, 18/565613, 26/F62918, 679/032385), 32455-36 (18/441382, 18/461241, 26/F62582, 679/032389), 32455-38 (18/442383, 18/471242, 679/022353, 679/032363, 679/092507), 32455-40 (18/481243, 18/4812431, 26/F62583, 26F/62583, 679/022351, 679/032349), 32455-42 (18/491244, 26/F62584), 32455-44 (18/445386, 18/501245, 679/022354, 679/032366), 32455-46 (18/511246, 26/F62585, 679/032317, 679/032367), 32455-48 (18/231444, 18/446387, 679/022355, 679/032368), 32455-50 (18/531248), 32455-52 (18/541249, 679/032318, 679/032369), 32455-54 (18/377660, 18/392952, 18/551250), 32455-56 (679/032373), 32455-58 (18/378662, 18/412953, 18/571252), 32455-60 (679/032319, 679/032374), 32455-65 (18/591254), 32455-70 (18/601255, 26/F62586), 32455-75 (18/611256), 32455-80 (18/621257, 26/F62587), 32455-85 (18/231516, 26/F62588), 32455-90 (18/641259, 679/0323108), 32475-32 (26/F16726). 8. Article Number (Lot Numbers): 37455-18 (18/231558), 37455-20 (18/021319), 37455-22 (18/211320), 37455-24 (18/671425, 18/231558), 37455-26 (18/221322, 18/231449), 37455-28 (18/041323), 37455-30 (18/231324), 37455-32 (18/051325), 37455-34 (18/241326), 37455-36 (18/061375, 26/F62605), 37455-38 (18/251376), 37455-40 (18/532513, 18/691442, 26/F62606), 37455-42 (18/151343, 18/261380), 37455-44 (18/081388), 37455-46 (18/231515), 37455-48 (18/231514), 37455-50 (18/281394), 37455-52 (18/101395), 37455-54 (18/701444), 37455-56 (18/111408, 18/656368), 37455-60 (18/121449, 18/572515), 37455-65 (18/131479), 37455-70 (18/141480, 26/F62607), 37455-75 (18/151481, 26/F62608), 37455-80 (18/686476, 26/F62609), 37455-85 (18/171483, 26/F62610), 37455-90 (18/181484). 9. Article Number (Lot Numbers): 211911-4 (00/0825-10, 679/012425, 679/022531, 679/0323131, 679/062430, 679/0624301, 679/102431, 679/122267), 211911-5 (00/0724-28, 00/1225-04, 679/012426, 679/022321, 679/022518, 679/0323132, 679/052527, 679/0624311, 679/0624312, 679/102432), 211911-6 (00/1024-15, 679/012427, 679/022322, 679/022501, 679/042513, 679/062432, 679/0624322, 679/102433, 679/112177), 211911-7 (00/0724-31, 00/0724-32, 00/0724-33, 00/0724-34, 00/0724-35, 00/0725-16, 00/1225-05, 679/022323, 679/022502, 679/052529, 679/062231, 679/102434), 211911-8 (679/012428, 679/022503, 679/022532, 679/0323135, 679/112178, 679/112407), 211911-10 (00/0724-39, 00/1024-17, 679/0323127, 679/102429, 679/112179, 679/122266), 211911-12 (679/0323128, 679/102228, 679/112203, 679/112219), 211911-14 (679/0323129, 679/102229, 679/112221), 211911-16 (679/0323130, 679/062232, 679/112222), 211911-20 (679/062429, 679/112418, 679/122268). 10. Article Number (Lot Numbers): 212121-6 (679/052152, 679/062338, 679/122235). 11. Article Number (Lot Numbers): 212131-6 (679/062319, 679/122234). 12. Article Number (Lot Numbers): 212101-SM (679/042515, 679/052322, 679/122215, 679/122303, 679/122402). 13. Article Number (Lot Numbers): 212101-LA (00/0724-48, 00/1024-09, 679/062313, 679/062443, 679/112206, 679/122302, 679/122405). 14. Article Number (Lot Numbers): 212111-LA (679/032421, 679/042516, 679/062347, 679/062402, 679/062445, 679/122414), 212111-SM (00/0724-65, 00/1024-10, 00/1024-11, 679/022530, 679/032246, 679/062318, 679/062403, 679/062473, 679/092237, 679/112015, 679/122406). 15. Article Number (Lot Numbers): 212141-7 (00/0724-81, 00/0724-85, 679/032331, 679/052168, 679/062448, 679/122214), 212141-8 (679/022408, 679/032332, 679/052429, 679/062449, 679/0624491, 679/062474, 679/122233). 16. Article Number (Lot Numbers): 212151-7 (00/0624-06, 679/012449, 679/052153, 679/062219, 679/062450, 679/062475, 679/102230, 679/112239), 212151-8 (00/0624-11, 00/0724-51, 679/012450, 679/032248, 679/062451, 679/072508). 17. Article Number (Lot Numbers): 21194-6 (679/042247), 21194-7 (679/042249), 21194-8 (679/042250), 21195-10 (679/042252), 21195-12 (679/042253), 21195-7 (679/032221). 18. Article Number (Lot Numbers): 21208-13 (679/032414, 679/052428, 679/062122, 679/102435, 679/112162, 679/112174, 679/122221, 679/122222), 21209-13 (679/062442, 679/0624421, 679/112163, 679/112175, 679/112408, 679/122236). 19. Article Number (Lot Numbers): 21208-11 (679/012429, 679/062440, 679/0624401, 679/112160, 679/112172, 679/122219), 21209-11 (679/062441, 679/112161, 679/112173, 679/112412, 679/122237, 679/122238, 679/122239). 20. Article Number (Lot Numbers): 212061-10 (00/0724-110, 679/062311, 679/112217, 679/122218), 212061-14 (00/0724-42, 00/0724-47, 679/032238, 679/032337, 679/062312). 21. Article Number (Lot Numbers): 212071-10 (679/032415, 679/052329), 212071-14 (679/032338, 679/032416). 22. Article Number (Lot Numbers): 211751-5 (679/052320, 679/112180, 679/112202, 679/112220), 211771-4 (679/052321, 679/102227, 679/122301). 23. Article Number (Lot Numbers): 211821-10 (679/012423, 679/032333, 679/062426, 679/112176), 211821-11 (00/0724-71, 00/0724-74, 679/032334), 211821-12 (679/022320), 211821-14 (679/012424, 679/122217). 24. Article Number (Lot Numbers): 21161-4 (679/092320, 679/112201), 21161-6 (679/032305, 679/032306, 679/042304, 679/052506, 679/062218), 211621-4 (00/0724-18, 00/0724-63, 679/042305, 679/062423, 679/102226, 679/112414), 211621-6 (00/0825-13, 679/022529, 679/042306, 679/062424, 679/112415). 25. Article Number (Lot Numbers): 211631-6 (00/0125-35, 679/022515, 679/032315, 679/062302, 679/062425, 679/0624251, 679/112411), 211631-8 (00/0724-118, 00/1220-11, 679/062303, 679/122216).
Apr 1, 2026
View details →Merit medical systems, inc.
High PriorityActive
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
REF:UDI-DI/Lot: CENFP15K/A:00884450199992/H3357122; CENFP15K/B: CENFP17K/A:00884450200001/H2643728, H2644554, H2755843, H2777866, H3357123; CENFP19K/A:00884450200018/H2415318, H2466455, H2466456, H2608337, H2632772, H2632921, H2643525, H2643729, H2658246, H2658395, H2663614, H2708827, H2777850, H2817064, H2817066, H2834183, H2834184, H2835774, H2875195, H2892153, H2900496, H2900649, H2918430, H2938756, H2982068, H2998532, H3019164, H3028009, H3089474, H3096774, H3101839, H3110067, H3123035, H3131873, H3139507, H3143969, H3152236, H3328470, H3332131, H3332133, H3357124, H3383280, H3398546; CENFP23K/A:00884450200025/H2368055, H2460265, H2543292, H2612929, H2622368, H2623456, H2631340, H2640771, H2663612, H2663613, H2719753, H2812164, H2817069,, H2834179, H2834181, H2847016, H2868174, H2880283, H2897527, H2900497, H2900550,, H2907334, H2911460, H2938761, H2978595, H2990699, H3004608, H3019163, H3049760,, H3049761 H3052479 H3071291 H3075039, H3089475, H3092914, H3096777, H3104588,, H3107507, H3120779, H3131874, H3143970, H3145117, H3191613, H3211721 H3316467,, H3328494, H3332218, H3332219, H3332220, H3351695;, CENFP27K/A:00884450200056/H2286892, H2480924, H2623453, H2643731, H2643732, H2653626, H2663616, H2777861, H2798003, H2833668, H2834185, H2880284, H2900619, H2907339, H2910719, H2911565, H2978601, H2986646, H2998508, H3004606, H3013812, H3019148, H3096779, H3110068, H3131879, H3143988, H3145119, H3156431, H3357125, H3383281; CENFT15K: H2845485,H2907340, H2911505, H2978606, H3004602; CENFT15K/D: H3071303, H3075046, H3116838; CENFP31K/A:00884450200063/H2623455, H2643737, H2663617, H3052480, H3071293, H3071294, H3110069, H3113265, H3143998, H3196708, H3328496, H3332421; CENFT17K:00884450276082/H2750962, H2755782, H2777600, H3034899, H3059017, H3059018, H3062346; CENFT17K/A:00884450295526/H2911456; CENFT17K/D:00884450820773/H3139508; CENFT19K:00884450276105/H2632775, H2658397, H2709212, H2817067, H2821275, H2835372, H2856854, H2864393S1, H2884659, H2900500, H2907322, H2907349, H2918517, H2933863, H2937909, H2937910, H2978622, H2999167, H3019145, H3034898, H3049764; CENFT19K/A:00884450295540/H2907422; CENFT19K/B:00884450725993/H2801414; CENFT19K/D:00884450820780/H3049766, H3049767, H3071304, H3075050, H3089478, H3126999, H3144001, H3152238, H3156433, H3162590, H3179819, H3196714, H3221338, H3233980, H3239914, H3253651, H3261220, H3283451, H3306069, H3350849, H3357127, H3357128, H3365884, H3372112, H3398547; CENFT23K:00884450276129/H2368107, H2657097, H2709213, H2719652, H2783586, H2812165, H2834187, H2834188, H2864382S1, H2870049, H2892155, H2898665, H2900501, H2907365, H2911451, H2911452, H2934395, H2971862, H2986161, H2986162, H2998549, H3007025, H3019139, H3028000; CENFT23K/A:00884450295564/H2709157, H2817068, H2911454, H2990794, H3013830, H3019136, H3034895; CENFT23K/B:00884450726006/H2801413; CENFT23K/D:00884450820797/H3049771, H3049772, H3071305, H3071306, H3145122, H3152240, H3170518, H3196713, H3201956, H3211729, H3221345, H3233987, H3239915, H3249275, H3275167, H3301761, H3306072, H3323733, H3332225, H3342600; CENFT27K:00884450276143/H2618709, H2642807, H2783590, H2817065, H2835374, H2884649, H2892156, H2900227, H2910433, H2937927, H2949972, H2971939, H3019133, H3027993, H3059051, H3062349, H3071308; CENFT27K/A:00884450295588/H2831335, H2847031, H2911463, H3019129; CENFT27K/B:00884450726013/H2801412; CENFT27K/D:00884450820803/H3049776, H3049777, H3080509, H3152241, H3179811, H3186110, H3191615, H3201954, H3206164, H3301764, H3323734, H3342755, H3372113, H3385315; CENFT31K:00884450276167/H2821396, H2884650, H2900615, H2911536, H2933865, H2971861, H3003224, H3059059, H3059060, H3089477, H3101838; CENFT31K/A:00884450295601/H2938653, H3013843; CENFT31K/B:00884450726020/H2811536; CENFT31K/D:00884450820810/H3071085, H3071309, H3082414, H3144317, H3163092, H3179823, H3191620, H3206153, H3239916, H3249277, H3275168, H3283445, H3306075, H3323741
Apr 1, 2026
View details →Olympus corporation of the americas
High PriorityActive
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Model: 3005PK; UDI: 00821925036000; Lot Numbers: All unexpired;
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 31404-16 (679/062339, 679/122213, 679/122332), 31404-18 (679/122212, 679/062340), 31404-20 (18/089221, 679/062343, 679/122241), 31404-22 (18/061535, 679/012416, 679/062350), 31404-24 (18/071536, 679/062362, 679/122246), 31404-26 (679/122245, 679/062363), 31404-28 (18/186278, 679/062364), 31404-30 (18/187299, 679/012401, 679/062365, 679/122242), 31404-32 (18/111540, 679/062366, 679/122211), 31404-34 (679/122206, 18/121544, 679/012402, 679/042414, 679/072302, 679/122206), 31404-36 (18/188300, 679/052403, 679/072305, 679/112223), 31404-38 (18/189301, 679/112213, 679/012455, 679/072309), 31404-40 (18/181043, 679/062321, 679/122201, 679/122310, 679/052404, 679/032532), 31404-42 (679/122203, 18/191303, 679/072310, 679/012418, 679/052424, 679/052505), 31404-44 (18/192304, 679/112232, 679/052332, 679/052425, 679/052508), 31404-46 (679/122240, 679/062322, 679/112210, 679/052426, 679/042505), 31404-48 (679/052427, 679/072317, 679/122248), 31404-50 (18/194306, 679/112228, 679/062301, 679/122311, 679/052406, 679/052413, 679/042506, 679/062501), 31404-55 (18/195307, 679/122258, 18/211647, 679/072326, 679/012452, 679/062467, 679/062511), 31404-60 (18/196308, 679/112240, 679/052325, 679/122312, 679/062485, 679/062512), 31404-65 (679/122259, 679/072327, 18/205310, 679/022410), 31404-70 (679/012301, 18/197309, 679/072328, 679/022413, 679/062479), 31404-75 (18/205411, 18/381989, 679/012302), 31404-80 (18/172638, 18/205232, 18/321164, 679/022416), 31457-30 (26/F50332), 31457-36 (18/198343), 31457-40 (18/199344), 31457-46 (18/947783, 18/736681), 31457-50 (18/201346, 26/F67796), 31457-55 (18/202347, 26/F67797), 31457-60 (18/203355), 31652-100 (679/122117, 679/022350, 679/102335, 679/022335, 18/924999), 31652-105 (679/022336, 679/032377), 31652-110 (679/032380, 679/102339), 31652-115 (679/102336), 31652-120 (679/092002, 679/102347), 31652-25 (679/112134, 679/032340), 31652-30 (679/032341), 31652-35 (679/082315), 31652-40 (679/082316), 31652-45 (679/032330, 679/092332), 31652-55 (679/032391, 679/092333), 31652-60 (679/022337, 679/032378, 679/092336), 31652-65 (679/022338, 679/032322, 679/092347), 31652-70 (679/032320, 679/032365, 679/042405, 679/112154), 31652-75 (26/F65330, 679/032348, 679/032386), 31652-80 (679/112181, 679/032321, 679/092350, 679/032362, 679/092348, 679/042410, 18/920995), 31652-85 (679/122145, 679/032382, 679/022349, 679/102301, 679/102305, 679/042411, 18/541045), 31652-90 (679/012201, 679/032383, 679/032383, 679/022347, 679/042406), 31652-95 (18/923998, 679/012202, 679/032316), 31731-100 (18/775943, 26/F58803, 679/102420), 31731-105 (18/776944, 26/F58804, 26/F65649, 679/102421), 31731-110 (26/F58805, 26/F65650, 679/102422), 31731-115 (26/F58806, 26/F65651, 679/102423), 31731-120 (26/F58807, 26/F65652, 679/102436), 31731-50 (09/1244, 26/F14488, 26/F21185, 26/F58793), 31731-60 (26/F58795, 26/F65655), 31731-65 (26/F65656, 26/F58796), 31731-70 (26/F58797, 26/F65657), 31731-75 (26/F58798, 26/F65658), 31731-80 (679/072040, 26/F58799, 26/F65659), 31731-85 (18/331317, 26/F65660, 679/072044), 31731-90 (09/1247, 09/1248, 26/F58801, 26/F65661, 46/612), 31731-95 (18/581247, 26/F58802, 26/F65662, 679/102437), 31732-60 (18/961265), 31734-100 (26/F65672), 31734-105 (26/F58839, 26/F65673), 31734-110 (26/F58840, 26/F65674, 679/032425), 31734-115 (26/F65675), 31734-120 (26/F58842, 26/F65676, 26/F72277), 31734-45 (18/761192), 31734-50 (26/F58828, 26/F65680), 31734-60 (26/F58830), 31734-65 (26/F58831, 26/F65683, 679/032428), 31734-70 (26/F58832, 26/F65684, 26/F72275, 679/032429), 31734-75 (26/F58833, 26/F65685), 31734-80 (26/F58834, 26/F65686, 679/032435), 31734-85 (26/F58835, 26/F65687, 26/F72276), 31734-90 (26/F65688, 679/032436), 31734-95 (26/F58837, 26/F65689, 679/042401). 2. Article Number (Lot Numbers): 31277-18 (26/F36049), 31357-20 (18/091247), 31357-22 (679/031707), 31357-24 (86/485378), 31357-26 (18/121250), 31357-28 (26/F65909), 31357-30 (18/165201, 18/341054), 31357-32 (18/166217), 31357-34 (18/167218), 31357-36 (18/168219, 26/F65910), 31357-38 (18/167220), 31357-40 (26/F65911, 18/170221), 31357-42 (26/F65912), 31357-44 (18/171222, 18/361059, 26/F65913), 31357-46 (18/861060), 31357-48 (18/172223, 26/F65914), 31357-60 (26/F65648), 31357-65 (679/012125), 31357-70 (18/902013). 3. Article Number (Lot Numbers): 36851 (26/F59918, 26/F61351, 26/F64885, 26/F64886, 26/F65908, 26/F66506, 26/F71413, 26/F71764, 26/F72364, 26/F73020, 26/F74288). 4. Article Number (Lot Numbers): 36432 (26/F65379, 26/F67799, 26/F72744, 774/300002), 36653 (26/F62590, 26/F68455), 36732 (26/F67800). 5. Article Number (Lot Numbers): 36431 (26/F62589, 26/F65378, 26/F66505, 26/F67798, 26/F70092, 26/F72743, 26/F73017, 26/F73494), 36651 (26/F61694, 26/F65380, 26/F68454, 26/F73018), 36653 (26/F73019), 36731 (26/F60987, 26/F62591, 26/F67523, 26/F70093, 26/F72363, 26/F73495).
Apr 1, 2026
View details →Philips ultrasound, inc
High PriorityActive
Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824.
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1. Article Number (Lot Numbers): 37303-10 (18/151720, 18/268729, 679/032432, 679/072268, 679/102237, 679/102307), 37303-12 (18/570637, 679/032434, 679/072269, 679/102346, 679/112227), 37303-14 (18/751091, 26/F66913, 679/012510, 679/062288, 679/102359, 679/112410), 37303-16 (679/072263, 679/102245, 18/151841, 26/F66914, 18/331193, 18/543625, 679/012511, 679/042403, 679/102360), 37303-18 (18/151942, 18/210467, 18/231415, 18/341194, 18/572633, 18/771093, 679/012512, 679/022507, 679/042404, 679/102248, 679/112319), 37303-20 (18/152043, 18/211468, 18/351195, 18/573634, 18/701585, 18/781094, 679/022508, 679/042420, 679/112216, 679/112328), 37303-22 (18/171705, 18/212469, 18/361196, 18/574635, 18/791095, 679/022509, 679/042417, 679/112224, 679/112340), 37303-24 (18/575639, 18/741572, 26/F66915, 679/022510, 679/112226, 679/122313, 679/122333), 37303-26 (18/152346, 18/214471, 26/F66916, 679/012403, 679/112230, 679/122323), 37303-28 (26/F66917, 679/112231, 679/122328), 37303-30 (18/192716, 18/591743, 679/122334). 2. Article Number (Lot Numbers): 32271-10 (18/061949, 18/231167, 679/062351), 32271-12 (18/048927, 26/F66235, 679/042215, 679/062342, 679/062405, 679/062489, 679/072271), 32271-14 (18/049928, 18/231165, 26/F66140, 679/042210, 679/052340, 679/052518, 679/062471, 679/062490, 679/072267), 32271-16 (18/231164, 18/311125, 26/F66141, 679/042216, 679/052519, 679/062315, 679/062483, 679/072272, 679/072401), 32271-18 (18/062950, 26/F65556, 26/F66236, 679/032261, 679/062332, 679/072402), 32271-20 (18/063951, 26/F66237, 679/052326), 32271-22 (18/064952, 26/F65557, 679/032263, 679/062354), 32271-24 (18/065953, 26/F65558, 679/062333), 32271-26 (679/032265), 32271-28 (26/F65559, 679/062357, 679/052520), 32271-32 (26/F65561), 32271-34 (26/F65562). 3. Article Number (Lot Numbers): 37304-10 (18/635486, 26/F24799, 679/012419, 86/011176), 37304-12 (18/061352, 18/521172, 18/5211721, 18/576643, 18/630487, 679/012433, 679/092207, 679/122409), 37304-14 (18/081360, 18/531173, 18/5311731, 18/577644, 18/631488, 679/012434, 679/092208, 679/122410), 37304-16 (18/541174, 18/578645, 18/632489, 679/012444, 679/092201, 679/122411), 37304-18 (18/092020, 18/551175, 18/633490, 679/022403, 679/092202), 37304-20 (18/011320, 18/561176, 18/634491, 679/012287, 679/012420, 679/082217, 86/483331), 37304-22 (18/241273, 679/012288, 679/012421), 37304-24 (18/021321, 18/571177, 679/012289, 679/012445). 4. Article Number (Lot Numbers): 21413-6 (26/F52124). 5. Article Number (Lot Numbers): 21431-ME (679/102045). 6. Article Number (Lot Numbers): 21482 (679/092020), 21483 (26/F55902). 7. Article Number (Lot Numbers): 21421-5 (26/F65377, 679/092039). 8. Article Number (Lot Numbers): 37241-10 (18/012169, 18/610104, 18/701013), 37241-12 (18/231295, 18/767108), 37241-14 (18/511016, 18/537392, 26/F24807, 679/012280), 37241-16 (18/005340, 18/121106, 18/231387, 18/521017, 18/560517), 37241-18 (18/232328, 18/531018, 679/072408, 86/311848), 37241-20 (18/233388, 18/541020, 18/562519, 679/072419, 86/287847), 37241-22 (18/066109, 18/234389, 18/551021, 26/F24594, 26/F24811), 37241-24 (18/561022, 18/564521, 18/608110, 26/F24595), 37241-26 (18/611111, 18/711023, 26/F24596, 26/F24813), 37241-28 (18/612112, 18/721024, 18/811597, 26/F24597, 86/485508), 37241-30 (18/015172, 18/613113, 18/731019, 26/F24598). 9. Article Number (Lot Numbers): 21015-08 (00/0123-12, 00/0321-43, 00/0723-07), 21015-09 (00/0123-13).
Apr 1, 2026
View details →I.t.s. gmbh
High PriorityActive
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
1 Article number (Lot Numbers): 21112-7 (643/0549), 21114-5 (643/032301, 643/042303, 643/042304, 643/0618, 643/102211, 643/112304), 21113-9 (643/072320). 2. Article number (Lot Numbers): 21111-6 (643/032306, 643/072319, 643/112201), 21111-8 (643/032318), 21111-12 (643/032305).
Apr 1, 2026
View details →Philips respironics, inc.
High PriorityActive
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
All Model No.; All UDI; All Serial No.
Apr 1, 2026
View details →Erbe usa inc
High PriorityActive
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
Probes may rupture/burst during activation
UDI: 04050147021785/ Lots: WO461310 WO461311 WO461312 WO461314 WO461315 WO461829 WO461831 WO461832 WO461833 WO461834 WO461835 WO461842 WO461843 WO461844 WO461847 WO461848 WO462117 WO462118 WO462119 WO462120 WO462121 WO462122 WO462123 WO462124 WO462125 WO462128 WO462129 WO462130 WO462373 WO462374 WO462375 WO462376 WO462377 WO462378 WO462379 WO462380 WO462387 WO462388 WO462389 WO462397 WO462825 WO462826 WO462827 WO462828 WO462829 WO462830 WO462831 WO462838 WO462839 WO462840 WO462841 WO462842 WO462843 WO462844 WO462845 WO462846 WO462847 WO462848 WO462849 WO463308 WO463309 WO463310 WO463311 WO463312 WO463313 WO463314 WO463316 WO463317 WO463390 WO463391 WO463392 WO463393 WO463394 WO463395 WO463396 WO463397 WO463398 WO463399 WO463400 WO463401 WO463402 WO463403 WO463404 WO463405 WO463406 WO463407 WO463408 WO463409 WO464270 WO464271 WO464272 WO464273 WO464274 WO464275 WO464276 WO464277 WO464278 WO464279 WO464699 WO464700 WO464701 WO464702 WO464703 WO464994 WO464995 WO464996 WO464997 WO465021 WO465022 WO465023 WO465024 WO465025 WO465026 WO465027 WO465050 WO465051 WO465052 WO465053 WO465054 WO465055 WO465056 WO465057 WO465066 WO465067 WO465068 WO465069 WO465243 WO465244 WO465245 WO465246 WO465247 WO465248 WO465249 WO465255 WO465256 WO465257 WO465258 WO465259 WO465260 WO465261 WO465262 WO465266 WO465267 WO465268 WO465269 WO467858 WO467859 WO467860 WO467861 WO467862 WO467863 WO467884 WO467885 WO467886 WO468210 WO468211 WO468212 WO468213 WO468214 WO468215 WO468216 WO468217 WO468218 WO468219 WO468220 WO468221 WO468230 WO468231 WO468232 WO468609 WO468610 WO468611 WO468612 WO468613 WO468614 WO468618 WO468619 WO468620 WO468621 WO468622 WO468623 WO468624 WO468625 WO468626 WO468627 WO468628 WO468629 WO468630 WO468631 WO468632 WO468634 WO468635 WO468636 WO468637 WO468638 WO468639 WO468640 WO468641 WO468654 WO468655 WO468656 WO468657 WO468658 WO468659 WO468660 WO468661 WO468662 WO468663 WO468664 WO468665 WO468666 WO468669 WO468670 WO469350 WO469351 WO469352 WO469353 WO469354 WO469357 WO469358 WO469359 WO471335 WO471336 WO471337 WO471338 WO471339 WO471340 WO471341 WO471342 WO471344 W4468495 W4465348 W2469080 W2469062 W2469061 W2469059 W2469058 W2468858 W2465755 W2465609 W2463595 W2463592 W2463591 W2463590 W2463589 W2462285 W2462282 W2462281 W2462280 W2462279 W2459857 W2459856 W2459855
Apr 1, 2026
View details →Convatec, inc
High PriorityActive
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Drainable large pouch may leak due to manufacturing issue.
UDI: 00768455221400/ Lot: 5J03908
Mar 25, 2026
View details →Baxter healthcare corporation
High PriorityActive
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Lot Code: " Code: HKO " Version or Model: 901029 " Catalog Number: VS100 " Company Name: WELCH ALLYN, INC. " Primary DI Number: 00732094214154 " Packaging DI Number: 00732094212228 " Description: VS100 UDI BASE " Software version: 3.2.0.1 " Serial Numbers: Refer to attached Affected Table
Mar 25, 2026
View details →Ge medical systems, llc
High PriorityActive
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
UDI Numbers: (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1035825832001 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(01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)008406821
Mar 25, 2026
View details →Ge medical systems, llc
High PriorityActive
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
Product ID Numbers: 4446-2-Centricity Universal Viewer-00558643 100256-3-Centricity Universal Viewer-00558700 101044-1-Centricity Universal Viewer-00558694 13240-2-Centricity Universal Viewer-00558103 4441-1-Centricity Universal Viewer-00558677 4578-1-Centricity Universal Viewer-00558340 10831-2-Centricity Universal Viewer-00558682 656341-Centricity Universal Viewer-01431499 50567-Centricity Universal Viewer-02176369 2690973-Centricity Universal Viewer-01454622 EG1526-Centricity Universal Viewer-00158976 A91901-Centricity Universal Viewer-00044549 M3488569-Centricity Universal Viewer-00071707 25540620 - HC4105-Centricity Universal Viewer-00001393 416005-Centricity Universal Viewer-00260808 1868708X - 556162-Centricity Universal Viewer-00157857 HKOB01-Centricity Universal Viewer-01282268 BMH-Centricity Universal Viewer-01820534 JIPMER-Centricity Universal Viewer-01820555 4347967-Centricity Universal Viewer-01474540 651342-Centricity Universal Viewer-01365218 651342-Centricity Universal Viewer-01365213 A3431341-Centricity Universal Viewer-00545677 473265-Centricity Universal Viewer-01442014 JP-131575-Centricity Universal Viewer-01275307 442900-Centricity Universal Viewer-01460668 577127-Centricity Universal Viewer-01444349 349551-Centricity Universal Viewer-02350518 PL3277-Centricity Universal Viewer-00038831 RU3866-Centricity Universal Viewer-01445731 RU8945-Centricity Universal Viewer-01445740 RU2580-Centricity Universal Viewer-01445743 1354732-Centricity Universal Viewer-01273292 RU3453-Centricity Universal Viewer-01273249 SA2160-Centricity Universal Viewer-00111827 SA1208-Centricity Universal Viewer-00066587 882983-Centricity Universal Viewer-02277629 ZA2533-Centricity Universal Viewer-00116577
Mar 25, 2026
View details →Lemaitre vascular, inc.
High PriorityActive
Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
REF#: AG740; UDI-DI: 00316837000299; Serial Number: 24GG298-022; Expiration Date: 28Jun2027;
Mar 25, 2026
View details →Hologic, inc.
High PriorityActive
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Due to product exhibiting potential to generate either invalid or false negative results.
Lot Code: The Aptima HPV Assay Kit Part Number 303585, Master Lot 929785 contains one Refrigerated Box (PN 302883) and one Room Temperature Box (PN 302885). The following are the UDI number for each box: UDI Number for PN 302883: 15420045500051 UDI Number for PN 302885: 15420045500068
Mar 25, 2026
View details →Convatec, inc
High PriorityActive
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Drainable large pouch may leak due to manufacturing issue.
UDI: 00768455221363 Lot: 5K01728
Mar 25, 2026
View details →Abbott diagnostics scarborough, inc.
High PriorityActive
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
Mar 25, 2026
View details →Stryker medical division of stryker corporation
High PriorityActive
Cub Pediatric Crib, Model FL19H
Cribs sold in the USA are missing two access door warning labels.
UDI-DI (GTIN) 07613327169348 Serial Numbers F61948 F61875 F61710 F62449 F62450 F62451 F62452 F62047 F62048 F62498 F62499 F62500 F61619 F61620 F61621 F61622 F61623 F61624 F61625 F61626 F61627 F61628 F61629 F61630 F61631 F61632 F61633 F61634 F61635 F61636 F61637 F61638 F61639 F61640 F61641 F61642 F61643 F61644 F61645 F61646 F61647 F61648 F61649 F61650 F61651 F61652 F61653 F61654 F61655 F61656 F61657 F61658 F61659 F61660 F61661 F61662 F61663 F61664 F61665 F61666 F61667 F61668 F61669 F61670 F61671 F61672 F61673 F61674 F61675 F61676 F61677 F61678 F61679 F61680 F61681 F61682 F61683 F61684 F61685 F61686 F61687 F61688 F61889 F61890 F61891 F61892 F61893 F61698 F61699 F62448 F61972 F61988 F61989 F62181 F62501 F62502 F62532 F62533 F62432 F62446 F62447 F61595 F61992 F61993 F62125 F62389 F61894 F62123 F61742 F61743 F62117 F62118 F62119 F62433 F62434 F62435 F62436 F62437 F61917 F61918 F61919 F61920 F61921 F61922 F61923 F61924 F61925 F61926 F61927 F61928 F61929 F61930 F61865 F61866 F62159 F62160 F62161 F62325 F62158 F62204 F62205 F62524 F62525 F61695 F61696 F61729 F62083 F62084 F62085 F62086 F62087 F61763 F61764 F61765 F61766 F61767 F61768 F61769 F61770 F61771 F61772 F62431 F62394 F62395 F62396 F62397 F62398 F62399 F62400 F62401 F62402 F62403 F62419 F62420 F62421 F62422 F62423 F62424 F62425 F61998 F61693 F61694 F62530 F62531 F61697 F61700 F62371 F62372 F62373 F62374 F62375 F62195 F62015 F62248 F62249 F62380 F61945 F61946 F61947 F62146 F62147 F62331 F62332 F62333 F62334 F61933 F61934 F61935 F61936 F61937 F61938 F61939 F61940 F61941 F61942 F61943 F61944 F61575 F61576 F61577 F61604 F61605 F61606 F61607 F61608 F61609 F61611 F61612 F61613 F61614 F62010 F62011 F62012 F62013 F62014 F61910 F61911 F61912 F61785 F62044 F62045 F61991 F62462 F61826 F61827 F61828 F61829 F61830 F61831 F61832 F61833 F61834 F61835 F61836 F61837 F62116 F62246 F62247 F62459 F62460 F62518 F62519 F61741 F61745 F61746 F62177 F62178 F62179 F62180 F62453 F62454 F61915 F61916 F62552 F62553 F62554 F62555 F62556 F62557 F62558 F62559 F62126 F62335 F62336 F62337 F62338 F62339 F62340 F62341 F62342 F62343 F62344 F62345 F62346 F62347 F62348 F62349 F62350 F62351 F62352 F62353 F62354 F62355 F61570 F61970 F62503 F62504 F62505 F62506 F62507 F62508 F62509 F62510 F62511 F62512 F62513 F62514 F62515 F62516 F62517 F62305 F62429 F62430 F62303 F62304 F62370 F61788 F61789 F61790 F61791 F61792 F61793 F61794 F61795 F61796 F61797 F62226 F62227 F61881 F61882 F61883 F61884 F61885 F61886 F61887 F61888 F62077 F61711 F61712 F61713 F61714 F62382 F62388 F61717 F61718 F61719 F61720 F61721 F61736 F61737 F61738 F61739 F61740 F62033 F61701 F61702 F61703 F61704 F61705 F61857 F61858 F61786 F61787 F62306 F62307 F62356 F62357 F62358 F62359 F62360 F62361 F61581 F61715 F61716 F62148 F62149 F62150 F62151 F62152 F62153 F61838 F61839 F61840 F61841 F61842 F61843 F61913 F61914 F62108 F62109 F62110 F62111 F62112 F62113 F62127 F62128 F62129 F62130 F62131 F62132 F62120 F62464 F62466 F62467 F62468 F62469 F62470 F62471 F62472 F62473 F62474 F61449 F61450 F62463 F62287 F62288 F62289 F62290 F62291 F62309 F62310 F62311 F62312 F62313 F62314 F62315 F62316 F62317 F62318 F62319 F62320 F62321 F62322 F62323 F62324 F62362 F62363 F62043 F62404 F62405 F62194 F62364 F62365 F62366 F62367 F61735 F61761 F61762 F61747 F61748 F61749 F61760 F62156 F62157 F61864 F61447 F61971 F62016 F62228 F62229 F62230 F62231 F62232 F61582 F61583 F61584 F61585 F62080 F62081 F62196 F62197 F62198 F62529 F62520 F62521 F62522 F62523 F61851 F61852 F61853 F61854 F61855 F61856 F61730 F61731 F61732 F61733 F62497 F61579 F61744 F61750 F61751 F61752 F61753 F61754 F61755 F61999 F62000 F62001 F62002 F62003 F62004 F62005 F62006 F62007 F62008 F61773 F61774 F61990 F62042 F62465 F62250 F62251 F62252 F62253 F62254 F62255 F62256 F62257 F62258 F62259 F62260 F62261 F62262 F62263 F62264 F62266 F62267 F62268 F62269 F62270 F62271 F62272 F62273 F62274 F62275 F62276 F62277 F62278 F62279 F62280 F62281 F62282 F62283 F62284 F62285 F62286 F62292 F62293 F62294 F62295 F62296 F62297 F62298 F62376 F62416 F62417 F61571 F61572 F61573 F61574 F62049 F62050 F62051 F62052 F62009 F62368 F62369 F61931 F61932 F62021 F62022 F62023 F61592 F61593 F62409 F61580 F61589 F61590
Mar 25, 2026
View details →Convatec, inc
High PriorityActive
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
UDI: 00768455221264 Lot: 5K00011,5K00714
Mar 25, 2026
View details →Ge medical systems, llc
High PriorityActive
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
UDI Numbers: (01)00840682103800(10)6.0SP42094097001D (01)00840682103800(10)6.0SP7.12094097001H (01)00840682103800(10)60P102.2094097001H (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP62094097001D (01)00840682103800(10)6.0SP72094097001D (01)00840682103800(10)6.0SP72094097001D (01)00840682103800(10)6.0SP72094097001D (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)6.0SP5.0.12094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP5.0.1.12094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP5.0.12094097001D (01)00840682103800(10)6.0SP5.0.1.12094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP5.0.12094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP5.0.12094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60SP90182094097001H (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP7.12094097001H (01)00840682103800(10)6.0SP7.12094097001H (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP5.0.32094097001D (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)60P90111.2094097001H 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(01)00840682103800(10)60SP5.0.4.12094097001D (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P102.2094097001H (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P104.2094097001H (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP62094097001D (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)6.0SP5.0.32094097001D (01)00840682103800(10)6.0SP50412094097001D (01)00840682103800(10)60P102.2094097001H (01)00840682103800(10)6.0SP50412094097001D (01)00840682103800(10)6.0SP50412094097001D (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P102.2094097001H (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)60P104.2094097001H (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P104120
Mar 25, 2026
View details →Elekta, inc.
High PriorityActive
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Due to adapter not being properly aligned or locked in place.
Lot Code: 07340048303019 (Perfexion) and Serial Numbers: LGK Perfexion/11868-004/6002 LGK Perfexion/12214-003/6007 LGK Perfexion/10567-026/6011 LGK Perfexion/10567-024/6014 LGK Perfexion/12451-001/6019 LGK Perfexion/10064-008/6021 LGK Perfexion/18630-001/6031 LGK Perfexion/11813-003/6034 LGK Perfexion/11007-005/6035 LGK Perfexion/10908-003/6045 LGK Perfexion/13337-LGK001/6052 LGK Perfexion/10762-005/6057 LGK Perfexion/11550-001/6065 LGK Perfexion/14878-003/6067 LGK Perfexion/11792-005/6077 LGK Perfexion/10356-007/6079 LGK Perfexion/10924-001/6089 LGK Perfexion/15045-LGK001/6091 LGK Perfexion/11848-003/6095 LGK Perfexion/12236-006/6097 LGK Perfexion/13558-001/6099 LGK Perfexion/20364-001/6103 LGK Perfexion/10848-LGK001/6108 LGK Perfexion/11390-LGK001/6109 LGK Perfexion/30002718-001/6113 LGK Perfexion/11433-LGK001/6116 LGK Perfexion/10643-005/6117 LGK Perfexion/11990-LGK001/6118 LGK Perfexion/12620-002/6120 LGK Perfexion/17322-001/6121 LGK Perfexion/105528-001/6122 LGK Perfexion/11999-001/6126 LGK Perfexion/10917-004/6128 LGK Perfexion/17357-001/6130 LGK Perfexion/10394-LGK01/6144 LGK Perfexion/30002934-ENS/6160 LGK Perfexion/10583-LGK002/6161 LGK Perfexion/16867-001/6166 LGK Perfexion/10929-LGK002/6175 LGK Perfexion/10424-001/6182 LGK Perfexion/17539-001/6185 LGK Perfexion/11377-003/6186 LGK Perfexion/16647-001/6187 LGK Perfexion/11733-001/6192 LGK Perfexion/10960-005/6193 LGK Perfexion/21061-001/6195 LGK Perfexion/11439-002/6196 LGK Perfexion/30000655-001/6199 LGK Perfexion/11731-005/6200 LGK Perfexion/11149-LGK002/6206 LGK Perfexion/11077-007/6207 LGK Perfexion/30001910-001/6208 LGK Perfexion/13514-001/6211 LGK Perfexion/10979-002/6213 LGK Perfexion/10208-003/6215 LGK Perfexion/11127-009/6219 LGK Perfexion/30000732-001/6223 LGK Perfexion/30001270-001/6225 LGK Perfexion/11420-001/6228 LGK Perfexion/30001527-001/6231 LGK Perfexion/10879-LGK002/6234 LGK Perfexion/10698-001/6237 LGK Perfexion/10711-002/6243 LGK Perfexion/10148-LGK002/6245 LGK Perfexion/12748-LGK001/6248 LGK Perfexion/11536-LGK002/6251 LGK Perfexion/10567-044/6253 LGK Perfexion/10425-LGK002/6254 LGK Perfexion/11434-LGK002/6255 LGK Perfexion/13031-LGK/6256 LGK Perfexion/11006-LGK002/6259 LGK Perfexion/30000722-003/6261 LGK Perfexion/10537-LGK002/6264 LGK Perfexion/30001107-002/6265 LGK Perfexion/10630-002/6266 LGK Perfexion/11524-002/8001 LGK Perfexion/12643-001/8010 LGK Perfexion/30003042-001/8011 LGK Perfexion/11695-LGK002/8015 LGK Perfexion/11322-002/8028 LGK Perfexion/10700-LGK002/8044 LGK Perfexion/12957-003/8053 LGK Perfexion/11787-003/8059 LGK Perfexion/30000346-001/8065 LGK Perfexion/30004796-RS001/8078 LGK Perfexion/11131-LGK002/8098 LGK Perfexion/13252-LGK001/8106 LGK Perfexion/30000269-LGK001/8109 LGK Perfexion/15490-003/8124 LGK Perfexion/30002079-LGK001/8180 07340048305587 (Icon) and Serial Numbers: LGK Icon/30004749-LGK001/8099 LGK Icon/14750-LGK001/8083 LGK Icon/12579-007/6250 LGK Icon/18850-500/8005 LGK Icon/11920-C5210/6088 LGK Icon/30004694-003/8064 LGK Icon/30000718-002/6246 LGK Icon/30004889-LGK001/8087 LGK Icon/14765-003/8027 LGK Icon/12473-003/6005 LGK Icon/12274-014/6209 LGK Icon/10611-001/6081 LGK Icon/11720-002/6143 LGK Icon/12846-004/6064 LGK Icon/12242-003/8085 LGK Icon/30005412-002/8114 LGK Icon/12178-002/8002 LGK Icon/12685-007/8105 LGK Icon/10545-009/8072 LGK Icon/12926-001/6212 LGK Icon/14915-003/6236 LGK Icon/30004236-003/8117 LGK Icon/30002968-004/8030 LGK Icon/12668-008/8178 LGK Icon/14983-500/6076 LGK Icon/11916-001/8056 LGK Icon/11083-HOM001/6070 LGK Icon/15554-001/8103 LGK Icon/15661-502/8121 LGK Icon/10247-002/6136 LGK Icon/30000736-003/8108 LGK Icon/30005910-001/8127 LGK Icon/11676-003/8040 LGK Icon/11976-502/8035 LGK Icon/11868-008/6131 LGK Icon/12947-003/8122 LGK Icon/11290-ENS1/6174 LGK Icon/18464-003/8066 LGK Icon/10795-K08002/6063 LGK Icon/30004024-RS01/6201 LGK Icon/11291-001/6018 LGK Icon/10326-003/6105 LGK Icon/21121-002/8067 LGK Icon/10783-003/8077 LGK Icon/30004796-RS001/8078 LGK Icon/30006128-500/8112 LGK Icon/30004887-LGK001/8069 LGK Icon/30006248-500/8125 LGK Icon/30000656-500/6227 LGK Icon/17414-004/8043 LGK Icon/17525-002/6038 LGK Icon/12629-003/6026 LGK Icon/15514-003/8034 LGK Icon/17522-001/6214 LGK Icon/20438-003/6013 LGK Icon/10416-LGK001/6125 LGK Icon/15748-LGK001/6106 LGK Icon/11019-LGK002/8071 LGK Icon/10997-LGK001/6087 LGK Icon/10832-LGK002/8115 LGK Icon/11992-LGK002/8029 LGK Icon/10654-LGK002/8100 LGK Icon/14900-LGK001/6058 LGK Icon/11230-LGK002/8025 LGK Icon/12958-LGK002/8096 LGK Icon/11639-LGK001/6042 LGK Icon/13480-LGK003/8095 LGK Icon/11892-LGK002/8057 LGK Icon/11414-LGK002/6205 LGK Icon/11986-LGK003/8088 LGK Icon/11143-LGK002/6257 LGK Icon/11991-LGK003/8084 LGK Icon/10362-LGK002/8039 LGK Icon/10959-LGK001/6132 LGK Icon/11784-LGK001/6055 LGK Icon/10648-LGK001/6098 LGK Icon/10514-LGK002/6183 LGK Icon/30000333-LGK002/8119 LGK Icon/10103-LGK02/6149 LGK Icon/30001254-001/8092 LGK Icon/10104-LGK002/8046 LGK Icon/11530-001/6101 LGK Icon/19100-LGK001/8033 LGK Icon/10234-002/6111 LGK Icon/11586-001/6157 LGK Icon/15416-001/6086 LGK Icon/10444-LGK004/8003 LGK Icon/10728-001/6062 LGK Icon/11352-001/6044 LGK Icon/17033-LGK002/8113 LGK Icon/10974-503/8061 LGK Icon/40017-002/6170 LGK Icon/17260-LGK001/8073 LGK Icon/19046-LGK001/8036 LGK Icon/11674-LGK001/8031 LGK Icon/12109-002/6169 LGK Icon/12959-002/6033 LGK Icon/10420-AVL-GK/6156 LGK Icon/10590-LGK-01/8097 LGK Icon/10209-001/6046 LGK Icon/30005199-LGK001/8090 LGK Icon/30001255-LGK001/8091 LGK Icon/30001751-002/6068 LGK Icon/30004975-LGK001/8102 LGK Icon/105618-001/6110 LGK Icon/19633-001/6154 LGK Icon/30003654-LGK001/8054 LGK Icon/14958-504/6155 LGK Icon/30004895-001/8104 LGK Icon/30000767-LGK001/6104 LGK Icon/30002955-001/8016 LGK Icon/11553-001/6024 LGK Icon/11582-LGK001/8111 LGK Icon/17032-LGK002/8129 LGK Icon/11418-LGK002/8051 LGK Icon/10476-LGK001/6263 LGK Icon/30007880-LGKVDH/8131 LGK Icon/10118-001/6230 LGK Icon/30007230-LGK001/8133 LGK Icon/19710-LGK002/8070 LGK Icon/13271-LGK01/8076 LGK Icon/12270-001/8050 LGK Icon/10886-013/6027 LGK Icon/18062-001/6146 LGK Icon/13160-001/6039 LGK Icon/14117-005/8055 LGK Icon/11090-005/6165 LGK Icon/10434-004/6244 LGK Icon/11328-020/8063 LGK Icon/11395-010/6032 LGK Icon/10568-007/8094 LGK Icon/12752-004/6242 LGK Icon/10817-009/6204 LGK Icon/10591-002/6083 LGK Icon/10567-038/6107 LGK Icon/14569-001/6135 LGK Icon/13779-002/8026 LGK Icon/11054-004/8038 LGK Icon/15053-001/6179 LGK Icon/10039-004/8048 LGK Icon/10071-007/6119 LGK Icon/13120-011/8013 LGK Icon/11073-016/8080 LGK Icon/17674-003/8037 LGK Icon/30002346-001/8058 LGK Icon/10899-007/6260 LGK Icon/10597-002/6167 LGK Icon/10383-007/6100 LGK Icon/10383-009/8120 LGK Icon/10193-007/6056 LGK Icon/30000118-001/6240 LGK Icon/11039-006/6188 LGK Icon/10760-006/6173 LGK Icon/16717-002/8116 LGK Icon/10387-018/6093 LGK Icon/10894-003/8042 LGK Icon/11138-004/6115 LGK Icon/12269-002/6082 LGK Icon/11791-006/6022 LGK Icon/11834-004/6222 LGK Icon/10313-010/8136 LGK Icon/10909-024/8107 LGK Icon/10982-003/6053 LGK Icon/10176-002/8086 LGK Icon/11347-003/6134 LGK Icon/11256-001/6012 LGK Icon/12108-004/8041 LGK Icon/11360-004/6059 LGK Icon/10436-009/6150 LGK Icon/13553-005/6249 LGK Icon/11198-009/8081 LGK Icon/10673-022/8012 LGK Icon/14236-001/6114 LGK Icon/10492-003/8019 LGK Icon/19112-LGK001/8060 LGK Esprit UDI-DI code: 07340201501139 and Serial Numbers: LGK Esprit/10711-LGK001/8195 LGK Esprit/30008463-0002/8179 LGK Esprit/30004455-LGK001/8148 LGK Esprit/10587-LGK001/8181 LGK Esprit/12236-LGK013/8197 LGK Esprit/14874-005/8138 LGK Esprit/14857-003/8160 LGK Esprit/30006645-LGK001/8196 LGK Esprit/10684-002/6090 LGK Esprit/30002563-LGK001/8144 LGK Esprit/18649-004/8139 LGK Esprit/20116-001/8192 LGK Esprit/30006828-001/8167 LGK Esprit/11154-GK007/8151 LGK Esprit/30002306-LGK001/8164 LGK Esprit/11563-LGK003/8171 LGK Esprit/11670-LGK002/8166 LGK Esprit/10375-LGK002/8126 LGK Esprit/30006511-LGK001/8149 LGK Esprit/15104-LGK002/8147 LGK Esprit/30008296-LGK001/6223 LGK Esprit/19115-LGK001/8193 LGK Esprit/12028-LGK002/6217 LGK Esprit/10523-LGK001/8187 LGK Esprit/10459-LGK002/8152 LGK Esprit/10158-LGK/8163 LGK Esprit/40023-LGK002/8162 LGK Esprit/10444-001/8185 LGK Esprit/11352-LGK002/8154 LGK Esprit/17033-003/8183 LGK Esprit/11245-LGK001/8017 LGK Esprit/13125-NUC001/8158 LGK Esprit/12027-ETZ-G2/8134 LGK Esprit/12946-LGK001/8014 LGK Esprit/30005168-503/8172 LGK Esprit/10076-GK002/8045 LGK Esprit/11234-LGK001/8130 LGK Esprit/10779-08/8024 LGK Esprit/13370-006/8173 LGK Esprit/30002888-LGK001/6159 LGK Esprit/30001913-LGK001/8032 LGK Esprit/30003406-LGK002/8022 LGK Esprit/12766-LGK003/8123 LGK Esprit/10622-014/8140 LGK Esprit/11373-010/8145 LGK Esprit/11396-004/8176 LGK Esprit/10643-007/8191 LGK Esprit/11175-013/6229 LGK Esprit/30000171-003/6172 LGK Esprit/10349-007/8161 LGK Esprit/10636-007/8062 LGK Esprit/10567-053/6232 LGK Esprit/10567-050/8052 LGK Esprit/10567-048/8142 LGK Esprit/10567-054/8168 LGK Esprit/12164-005/8153 LGK Esprit/14030-004/8146 LGK Esprit/11714-005/8184 LGK Esprit/11092-004/8188 LGK Esprit/10255-013/8165 LGK Esprit/10877-012/8169 LGK Esprit/11740-003/8135 LGK Esprit/12864-LGK001/8186 LGK Esprit/10379-004/8137 LGK Esprit/13826-003/6239 LGK Esprit/10383-LGK012/6100 LGK Esprit/14153-003/8175 LGK Esprit/11798-014/8156 LGK Esprit/11888-007/6171 LGK Esprit/11710-006/8170 LGK Esprit/11077-009/8190 LGK Esprit/11030-011/8155 LGK Esprit/10542-015/6238 LGK Esprit/11201-006/6047 LGK Esprit/19485-002/8174 LGK Esprit/10909-013/8020 LGK Esprit/11293-008/8182 LGK Esprit/11226-004/8177 LGK Esprit/11820-008/8006 LGK Esprit/11772-007/8143 LGK Esprit/11198-008/8082 LGK Esprit/10673-031/8141 LGK Esprit/30006566-003/8118 LGK Esprit/11848-007/6095 LGK Esprit/10714-013/8159
Mar 25, 2026
View details →Diagnostica stago, inc.
High PriorityActive
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Model/Catalog Number: REF 00515; UDIs: (1) (01)03607450005158(11)240630(17)250930(10)273015(241)00515, (2) (01)03607450005158(11)250325(17)260630(10)273127(241)00515, (3)(01)03607450005158(11)250416(17)260731(10)273275(241)00515, (4)(01)03607450005158(11)250527(17)260831(10)273567(241)00515, (5)(01)03607450005158(11)250618(17)260930(10)273681(241)00515, (6)(01)03607450005158(11)250716(17)261031(10)273808(241)00515, (7)(01)03607450005158(11)250716(17)261231(10)273808(241)00515, (8)(01)03607450005158(11)250909(17)261231(10)274108(241)00515 (9) (01)03607450005158(11)250326(17)260630(10)273128(241)00515, (10) (01)03607450005158(11)250429(17)260731(10)273606(241)00515, (11) (01)03607450005158(11)250709(17)261031(10)273805(241)00515, (12) (01)03607450005158(11)251007(17)270131(10)274219(241)00515; Lot numbers: (1)273015, (2)273127, (3)273275, (4)273567, (5)273681, (6)273808, (7)273995, (8)274108, (9)273128, (10)273606, (11)273805, (12)274219;
Mar 25, 2026
View details →Howmedica osteonics corp.
High PriorityActive
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
Part Number: 210490; UDI: (01)07613327523874(10)TU6563205RP; Lot numbers: ALL;
Mar 25, 2026
View details →Datascope corp.
High PriorityActive
Battery Charging Station; Model: 0998-00-0802;
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.
Model: 0998-00-0802; UDI: 10607567111964; Serial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI, 210018425EAI, 210020144EAI, 210020944EAI, 210022544EAI, 210020244EAI, 210022144EAI, 210020044EAI, 210020544EAI, 210021344EAI, 210023244EAI, 210018025EAI, 210019025EAI, 210021144EAI, 210021044EAI, 210022344EAI, 210019225EAI, 210019125EAI, 210018525EAI, 210022844EAI, 200017647EAI, 210019725EAI, 210022744EAI;
Mar 25, 2026
View details →Lutronic corporation
High PriorityActive
CLARITY II Laser System; Model No. 1110200210.
Reports of devices sparking/popping and potentially burning patients.
Model No. 1110200210; UDI: 08809447653723; Serial No. C3023K024, C3022B006, C3025D028, C3022L031, C3024D027, C3022H015, C3024K033, C3019J018, C3024K030, C3025B076, C3023K043, C3021K002, C3025E050, C3025E035, C3022L010, C3023G009, C3023J037, C3021D021, C3020C010, C3019L007, C3025B011, C3025B012, C3022G011, C3022F020, C3025D076, C3024J038, C3025E041, C3021L005, C3025C022, C3024G026, C3023B044, C3021F012, C3024G008, C3024D025, C3025E065, C3024F030, C3022H021, C3022H022, C3025C029, C3023L034, C3023L070, C3023D060, C3024H029, C3025D094, C3023L043, C3022M010, C3023C008, C3025D085, C3022J035, C3022K009, C3023K035, C3025B071, C3021F001, C3023J006, C3022L026, C3022J033, C3023J004, C3024G004, C3022D023, C3025E028, C3021L031, C3023K048, C3025D080, C3019M006, C3022A003, C3023K027, C3021K020, C3022K023, C3025D035, C3023J029, C3022E030, C3021L007, C3025B078, C3023J041, C3023A020, C3025E038, C3023H019, C3025C034, C3024J041, C3025E047, C3025D097, C3022E026, C3024J089, C3025B033, C3023B002, C3023B040, C3023B018, C3022K007, C3024F012, C3022G015, C3022J024, C3025B118, C3024J088, C3023L010, C3022F014, C3022F015, C3024J078, C3023L041, C3020K009, C3019J007, C3020K012, C3023B035, C3024J046, C3025D040, C3024J047, C3020J012, C3024J091, C3025D039, C3024M058, C3020L006, C3023E026, C3023E027, C3022K020, C3023L027, C3020L008, C3022L040, C3024G014, C3023M020, C3025E091, C3022A032, C3022B012, C3025E095, C3025C019, C3025C020, C3025C017, C3025C018, C3024D002, C3024C017, C3022J011, C3020H003, C3023H016, C3024C013, C3022A009, C3022J030, C3021F013, C3023E029, C3021M005, C3025E027, C3022K008, C3023K046, C3023D015, C3024G022, C3025B003, C3025E073, C3023L012, C3024H016, C3024J043, C3021G022, C3019K005, C3023G031, C3023E037, C3025E033, C3023M024, C3025D105, C3023F021, C3025E060, C3024F013, C3022E029, C3024K051, C3024J086, C3025C035, C3023E024, C3024J045, C3023J042, C3025B028, C3023F025, C3023L035, C3023C013, C3023D049, C3023D048, C3021J003, C3023F015, C3025E034, C3023A019, C3020G002, C3023D041, C3023D045, C3025D099, C3023G013, C3023D018, C3024M055, C3023C012, C3023F022, C3025C026, C3022L038, C3024H031, C302J009, C3025E032, C3024K117, C3022K006, C3024G017, C3024J049, C3022F001, C3023J017, C3022J027, C3021A007, C3023A024, C3024H077, C3024K016, C3025B079, C3023D002, C3022A033, C3023F020, C3023F019, C3022L036, C3023M021, C3024G018, C3025D084, C3025E006, C3024H021, C3024J036, C3022H013, C3025B118, C3024M060, C3024J075, C3022F019, C3019M009, C3019K003, C3023L039, C3024H016, C3022M016, C3024K113, C3022J028, C3022L056, C3022H014, C3022C011, C3021K004, C3024H079, C3025B074, C3024K054, C3023K031, C3022H020, C3024H074, C3023K030, C3022B005, C3025D081, C3024G010, C3025E056, C3021D018, C3021L030, C3025E025, C3019M001, C3021J001, C3021M018, C3022K019, C3021L008, C3021G020, C3019K009, C3023E035, C3022J029, C3021A008, C3025D102, C3024K114, C3022E020, C3020L003, C3023L044, C3024J042, C3023E038, C3023L068, C3022M004, C3023E040, C3024D031, C3019M007, C3023K042, C3024J054, C3024K023, C3023C016, C3023C020, C3024K035, C3022A007, C3023D044, C3023B005, C3022C009, C3024J081, C3023L069, C3022L003, C3024H028, C3019K004, C3025D030, C3024H061, C3024C018, C3025E011, C3025E052, C3021M007, C3025E075, C3025D083, C3025E054, C3020C007, C3025D101, C3024J044, C3024H030, C3025D043, C3023J036, C3025B072, C3025D082, C3023H017, C3024D028, C3023D014, C3022F010, C3023A026, C3025D096, C3023L037, C3024E007, C3025B115, C3024K111, C3023J005, C3025B113, C3023J039, C3023J011, C3023D021, C3019K008, C3024H015, C3024J090, C3023E023, C3023D059, C3023K022, C3022F005, C3024H041, C3023C018, C3023A022, C3023L033, C3025B073, C3025D095, C3022L033, C3023J014, C3022J025, C3019L004, C3025B009, C3025E051, C3020G003, C3024E009, C3024H014, C3022F021, C3025B111, C3022J002, C3022L041, C3021K021, C3025E023, C3025E071, C3022L049, C3024C019, C3023L019, C3023K049, C3023C010, C3020J005, C3021M011, C3021K003, C3023H014, C3022M006, C3023A021, C3021M010, C3025E029, C3023D012, C3020G008, C3024G024, C3025D103, C3024D023, C3023L073, C3022D025, C3024H034, C3023C006, C3022L039, C3024K116, C3024H024, C3021D017, C3023B004, C3024H071, C3021J033, C3022H025, C3024H033, C3021H017, C3025D098, C3023K034, C3023G025, C3024J003, C3024K020, C3019M008, C3025B037, C3025B036, C3022E016, C3022M009, C3025E049, C3023G026, C3023D008, C3024F011, C3025E039, C3022F012, C3023B041, C3024K057, C3025D065, C3024H075, C3023B042, C3024D026, C3021F011, C3024J035, C3024K021, C3021F008, C3023L014, C3024H020, C3023G016, C3020G009, C3024E005, C3025D061, C3022L057, C3020J013, C2014K002, C3023E041, C3025E074, C3025D045, C3025D086, C3024K022, C3025E036, C3025D027, C3023C017, C3022A002, C3025D036, C3023D016, C3023F016, C3024G016, C3025E076, C3025B119, C3023K044, C3022L018, C3024H040, C3024K027, C3019L001, C3025E013, C3020J004, C3023B010, C3022E014, C3022J008, C3022E017, C3022A034, C3023J034, C3024K034, C3024H068, C3023J043, C3023L076, C3022H024, C3025C031, C3023A028, C3019J010, C3022J015, C3023D043, C3023D050, C3023B016, C3022L006, C3022L005, C3025E062, C3023G024, C3023K041, C3022K010, C3023H015, C3025D100, C3025B034, C3025B031, C3022G014, C3025E066, C3025E014, C3025C016, C3023G010, C3022L042, C3022L043, C3022L044, C3023L071, C3023G029, C3023L007, C3025E044, C3020L001, C3021M004, C3024C012, C3025D029, C3022L028, C3022L035, C3025E063, C3025E048, C3022H018, C3022H019, C3022K013, C3021F010, C3020J014, C3020K011, C3022M007, C3021D016, C3025E093, C3022M008, C3024D030, C3025D063, C3023E042, C3022E028, C3025D037, C3022L007, C3025E021, C3024K050, C3023K047, C3025E017, C3022M014, C3023K036, C3023K050, C3023J002, C3024F027, C3025C028, C3022A035, C3025E072, C3024K120, C3024H067, C3024H064, C3024H063, C3024H065, C3022C029, C3025E019, C3024K025, C3022J014, C3022L027, C3022F006, C3023A023, C3022A031, C3022D024, C3025E094, C3020J008, C3019H008, C3024H070, C3024H060, C3021D022, C3024J084, C3024J075, C3025D042, C3024K119, C3025E089, C3019H002, C3019J017, C3023B017, C3022L009, C3025E030, C3023H020, C3022M005, C3022K014, C3025E064, C3022A028, C3024H037, C3019L002, C3024H072, C3022H016, C3024G005, C3020L002, C3024J039, C3025B080, C3022L055, C3023L009, C3023F017, C3025E018, C3025E097, C3025E043, C3023L013, C3022F009, C3021G001, C3019L006, C3022F017, C3024J002, C3022H017, C3021D019, C3023D017, C3024K112, C3022L052, C3022C004, C3022K024, C3023L045, C3022L058, C3023E032, C3024G003, C3024J083, C3024H018, C3023G033, C3021M014, C3022M013, C3022E022, C3021F004, C3023H023, C3023L020, C3024K026, C3020L004, C3022F002, C3025D079, C3023L023, C3021H013, C3023F029, C3021K005, C3025D032, C3024K115, C3024G027, C3024H017, C3023J032, C3023J038, C3023E033, C3023D005, C3024F010, C3023L018, C3024F009, C3022C010, C3024D024, C3021K001, C3023B036, C3019J014, C3025C027, C3024J006, C3019J008, C3022F016, C3023D055, C3023E031, C3023E039, C3022H012, C3023D042, C3021M015, C3025B117, C3023B012, C3023L028, C3023J040, C3022L019, C3024J009, C3024J010, C3024K055, C3023L039, C3022E027, C3025C023, C3023B043, C3025D034, C3024J087, C3022G018, C3023J012, C3023M027, C3024G007, C3023D046, C3023K028, C3024J052, C3023C005, C3024J037, C3024J093, C3024J079, C3023M023, C3023B019, C3021F014, C3025E009, C3023D019, C3022E015, C3023G032, C3022C023, C3023C014, C3022M011, C3024G009, C3024J076, C3022M003, C3022B013, C3020J007, C3025D044, C3025E008, C3020K010, C3024C015, C3022F007, C3023L022, C3022J026, C3024D029, C3023L016, C3019M004, C3021L004, C3025E067, C3024M062, C3022E023, C3023B039, C3022J001, C3023J033, C3024G019, C3025E092, C3019K010, C3023L024, C3025C030, C3023L046, C3025E016, C3023K029, C3022L053, C3023K045, C3023C007, C3025C021, C3023C004, C3025E020, C3023K023, C3024D005, C3024D001, C3025E057, C3022L037, C3021F007, C3021M012, C3024H038, C3024D004, C3023L042, C3023M019, C3024G025, C3022F008, C3021M013, C3022A037, C3019L003, C3025E090, C3025D088, C3025E012, C3019M005, C3022G017, C3024H026, C3024M056, C3022A008, C3025E010, C3023L015, C3024H036, C3024H035, C3022C012, C3023L038, C3024J080, C3023K025, C3024K118, C3025B007, C3020H005, C3024H039, C3023E034, C3023E028, C3023B001, C3022E032, C3021J020, C3025E042, C3025C032, C3024G023, C3022H026, C3024K028, C3023B037, C3023J009, C3025C025, C3021G021, C3021M003, C3023K038, C3023K033, C3025B035, C3024M061, C3023M026, C3024G013, C3024J092, C3025E096, C3022F019, C3019M003, C3022M015, C3022L013, C3023J016, C3025B077, C3024K019, C3021M008, C3024J082, C3024G021, C3025B029, C3021F002, C3019J015, C3024K024, C3022L050, C3024K053, C3025D033, C3024H019, C3023C015, C3022M012, C3025B114, C3020G004, C3024J051, C3022F003, C3022L017, C3023J010, C3025E040, C3020J009, C3023B038, C3022J032, C3021K019, C3024C014, C3024H025, C3024H022, C3022L004, C3021H015, C3022L011, C3022L034, C3022C024, C3023D020, C3023C022, C3025D062, C3022J022, C3025D092, C3022A004, C3022B010, C3022J003, C3025D041, C3022L054, C3024J007, C3024H069, C3020J003, C3025B110, C3022A010, C3022A005, C3023L021, C3024G006, C3023K032, C3022J031, C3022G013, C3025B116, C3021L033, C3021L032, C3022L021, C3022C006, C3022H023, C3020C008, C3025E068, C3023L006, C3021F006, C3022J023, C3024H032, C3025E005, C3023D054, C3019J016, C3022C027, C3024D003, C3022K025, C3022J007, C3025D093, C3025D078, C3024H042, C3024H078, C3023L040, C3022L008, C3023G012, C3023L077, C3025E098, C3025D026, C3024M054, C3023J008, C3023L031, C3023G017, C3024J048, C3024K049, C3023J003, C3024H012, C3024H013, C3023J030, C3021K018, C3023C021, C3021M006, C3025B004, C3025E015, C3024J077, C3019J009, C3023L032, C3024J008, C3019L005, C3022B008, C3025E055, C3024J074, C3023B013, C3022E021, C3023D004, C3022B014, C3021F005, C3020G005, C3022J034, C3025C033, C3025B030, C3024C011, C3023L025, C3023G018, C3025B075, C3024C016, C3022L051, C3022C005, C3025E053, C3022E025, C3021J019, C3024K048, C3025D090, C3025D064, C3025D091, C3022K021, C3021J031, C3020J010, C3024H062, C3021J002, C3025E007, C3023B020, C3024J040, C3021H012, C3023E030, C3023J031, C3023G011, C3024K031, C3022L032, C3023D009, C3022G016, C3022J004, C3019M010, C3020H004, C3024H023, C3019M002, C3025D031, C3022C026, C3024K017, C3021M020, C3022K017, C3023D013, C3024G015, C3023B021, C3022C025, C3022K022, C3023E025, C3024H073, C3025B112, C3022A001, C3023D057, C3021J021, C3023D047, C3024G020, C3022G019, C3025B006, C3024J085, C3022C008, C3023C019, C3022C003, C3021G004, C3023D003, C3021G003, C3022F004, C3024J053, C3022J013, C3022L045, C3021M009, C3021G005, C3024M057, C3024G012, C3024F028, C3021J004, C3020J015, C3022E018, C3020J011, C3021K022, C3022C007, C3025D077, C3023J015, C3023L017, C3023K039, C3022A006, C3021A006, C3022B009, C3024K018, C3022E031, C3021J005, C3020K008, C3023F018, C3021D001, C3023L075, C3022E033, C3021M002, C3021M001, C3021H014, C3025D087, C3025E070, C3023H018, C3024K052, C3024K032, C3021L002, C3024H076, C3021H016, C3022A029, C3022B007, C3021F015, C3021M017, C3021D020, C3021D023, C3022L029, C3022L030, C3022J005, C3023G015, C3025B008, C3023D010, C3020G006, C3023G027, C3024J005, C3025E058, C3021F003, C3025E059, C3022F018, C3023D051, C3023F026, C3020L007, C3023K040, C3025B032, C3022M002, C3023B024, C3021G002, C3023F023, C3022K018, C3022J006, C3022G010, C3023K037, C3023C003, C3023J035, C3024C020, C3021L003, C3025E061, C3023L074, C3023B003, C3022L015, C3022E019, C3023K021, C3022L002, C3024F029, C3023F027, C3023F028, C3025B005, C3022J021, C3025E024, C3023F024, C3024D022, C3024J004, C3020H001, C3023G030, C3025E037, C3023D052, C3021M021, C3022F013, C3025E031, C3025E022, C3025E026, C3023L008, C3022L020, C3022K011, C3025D104, C3024J001, C3023G028, C3024K029, C3023K026, C3024G011, C3023B022, C3025B010, C3023A025, C3023M025, C3024J050, C3025D038, C3019K001, C3022A030, C3021L006, C3022C028, C3024M063, C3020L005, C3021D015, C3021L029, C3025D089, C3021F009, C3023M022, C3019K007, C3023B011.
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-0027/11; UDI-DI: 04026575431953; Serial/Lot Number: 2549126, 2549127;
Mar 18, 2026
View details →Trividia health, inc.
High PriorityActive
Owner's Booklets and Instructions for Use that are used with the
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Device Item/UDI-DI: RE4H01P-40/21292006099, RE4H01P-43/21292006105, RE4212P-00/10840330705681, RE4099P-40/21292014919, RE4099P-43/21292008673, RE4051P-00/20612479197217, RE4068P-01/607415261097. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX PRO Owners Booklet/RE4TVHP03 Rev 56 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior,
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 360020-1P
The device does not bear a unique device identifier.
UDI-DI: 0085007365403; Serial Numbers: 11193097601 10216195501 10216195502 12193104901 06226342101 06226342102 06226342105 06226342107 03203148701 01226259601 10226410801 06246724701 10203210401 10203210402 05216113101 11193095401 01203118301 05216107301 05216107302 05216107303 05216107304 05216107305 05216108301 05216108302 06193030201 03203147601 09193066601 03216060801 07193052301 09236591501 02246673801 02192976301 03246682701 01192960801 01192960802 06236535501 08152390701 03216065101 05182864901 01142094001 11121856201 03192998301 01192959801 01226256901 03256938801
Mar 18, 2026
View details →International life sciences
High PriorityActive
Artelon FlexBand Dynamic Matrix Ref: 31057
Augmentation devices failed bacterial endotoxin testing.
A10011001/GTIN: 00850003396019
Mar 18, 2026
View details →Beckman coulter mishima k.k.
High PriorityActive
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
REF/UDI-DI/ Newer Instrument Installed with PC preinstalled with Microsoft SQL Server 2022 Express: B96697/14987666543016/2025061442, 2025061446, 2025061452, 2025061454, 2025061464, 2025071479, 2025071488, 2025081513, 2025081516, 2025091536, 2025091538, 2025091543, 2025091559, 2025091561, 2025111598, 2025111602, 2025111604, 2025111605, 2025111606, 2025121618, 2025121622, 2025121623. B96698/14987666543023/2025061449, 2025061451, 2025061457, 2025061467, 2025071475, 2025071476, 2025071478, 2025071481, 2025071495, 2025071497, 2025081503, 2025081524, 2025091539, 2025091549, 2025091551. Older Instrument Replaced with PC preinstalled with Microsoft SQL Server 2022 Express: B23279/14987666541296/2014011316, 2014071647, 2014121858, 2014121906. B23280/14987666541302/2016022593. B23281/14987666541319/5094354. B96697/14987666543016/2019074683. B96698/14987666543023/2017063377, 2019114891, 2024101288
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209;
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000 PAK, Part No. 00055360004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055360004; UDI: 08426950899662; Lot No. 251113U, 251201AI, 251202Q, 251223E, 251223P, 251229X.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No. 00055415005.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055415005; UDI: 08426950807667; Lots No. 251125S, 251201AJ, 251212O, 251218V, 251229X.
Mar 18, 2026
View details →Raz design inc
High PriorityActive
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair Catalog Number Z300 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR20 ZCSEAT (FAR) UDI-DI code: (01)00628758003007 Serial Numbers: RAT218789 RAT116906 RAT200337 RAT208010 RAT208987 RAT210426 RAT211344 RAT211837 RAT211998 RAT212001 RAT212066 RAT212450 RAT213190 RAT213227 RAT214334 RAT217987 RAT218213 RAT218552 RAT218570 RAT218612 RAT219142 RAT220066 RAT222210 RAT223140 RAT224902 RAT206923 RAT217768 RAT221724 RAT213036 RAT218862 RAT221044 RAT216437 RAT217073 RAT218555 RAT218557 RAT219817 RAT121348 RAT216055 RAT217379 RAT220648 RAT124264 RAT200864 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair Catalog Number Z333 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR20 ZCSEAT (FAR) UDI-DI code: (01)00628758003335 Serial Numbers: ART219556 ART222544 ART211605 ART223825 ART212722 ART212675 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair Catalog Number Z360 Seat Catalog Numbers: ZCSEATHD (FAR) UDI-DI code: (01)00628758003601 Serial Numbers: BAT216618 BAT204112 Raz-SP (Self Propel) Mobile Shower Commode Chair Catalog Number Z200 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR20 ZCSEAT (FAR) UDI-DI code: (01)00628758001003 Serial Numbers: RAS210872 RAS214903 RAS217818 RAS220760 RAS209166 RAS218239 RAS107030 RAS214470 Raz-AP (Attendant Propel) Mobile Shower Commode Chair Catalog Number Z100 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR 20 ZCSEAT (FAR) UDI-DI code: (01)00628758001003 Serial Numbers: RAS217210 RAS224711 RAS214364 FAR Seat (Demo) Catalog Numbers: ZVFI17FAR-A ZCSEAT-A UDI-DI code: N/A Serial Numbers: N/A
Mar 18, 2026
View details →Trividia health, inc.
High PriorityActive
Owner's Booklets and Instructions for Use that are used with the
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Device Item/UDI-DI: REA4001-01/311917173894, REA4002-01/96295129267, REA4007-01/50428354766, REA4011-01/87701427398, REA4019-01/708820685659, REA4020-01/41415072787, REA4025-01/93351022784, REA4031-01/41220009169, REA4054-01/10939742445, REA4066-01/11822590051, REA4081-01/21292015015, REA4081-40/21292007164, REA4081-43/21292007584, REA4089-01/52569139042, REA4094-01/681131240154, REA4094-01RX/681131403214, REA4203-01/41260007354, REA4211-01/10939958617, REA4H01-01/21292007010, REA4H01-40/21292007447, REA4H01-43/21292007911, International: REA4i03-01/N/A, REA4i03-02/N/A, REA4i04-00/21292012731, REA4i81-11/N/A, REA4i82-11/21292012212, REA4i82-12/21292009991. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX AIR Owner's Booklet/ REA4TVH03 Rev 57 and prior, TRUE METRIX AIR Owner's Booklet (English)/ REA4TVH35 Rev 51 and prior, TRUE METRIX AIR Owner's Booklet (Spanish)/ REA4TVH35S Rev 51 and prior, Relion (Walmart) TRUE METRIX AIR Owners Booklet/ REA4RLN03 Rev 52 and prior, Relion (Walmart) TRUE METRIX AIR Owner's Booklet - English/ REA4RLN35 Rev 52 and prior, TRUE METRIX AIR Owner's Booklet International Trividia House Brand/ REA4ITV03 Rev 55 and prior, TRUE METRIX AIR Owners Booklet for Trividia Health UK Limited/ REA4UKT03 Rev 55 and prior, Trividia Health LATAM - TRUE METRIX AIR Owners Booklet/ REA4LAT03 Rev 51 and prior, TRUE METRIX AIR Owners Booklet for Trividia Health Australia/ REA4AUT03 Rev 58 and prior.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No. 00055430008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055430008; UDI: 08426950807735; Lots No.: 251106X, 251110AF, 251202P, 251203Q, 251215J, 251229AG, 251229X, 251230P.
Mar 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
1) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22KMG297; 2) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22FMA481; 3) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21IMG797; 4) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMG569; 5) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMB801; 6) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 26ABL637; 7) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467M; 8) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467; 9) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBG183; 10) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25HBF488; 11) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25GBK350; 12) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25FBO822; 13) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBT976; 14) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP602; 15) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP589; 16) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP588; 17) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP587; 18) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP586; 19) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25DBB810; 20) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25ABA001; 21) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24HBM020; 22) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24GBC436; 23) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24FBS256; 24) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBP532; 25) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBA256; 26) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24ABN040; 27) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBP214; 28) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBJ077; 29) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23IBQ646; 30) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23HBU475; 31) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE710; 32) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE709; 33) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23FBF593; 34) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBJ852; 35) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBC954; 36) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 22KBO714; 37) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25IBK435; 38) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBT069; 39) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBO806; 40) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBH137; 41) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25GBA989; 42) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 24LBJ019
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097 , 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245 , 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013 , 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036 , 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014 , 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019 , 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254;
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-8521/15; UDI-DI: 04026575383283; Serial/Lot Number: 250805/0020, 250805/0021, 250805/0023, 250805/0024;
Mar 18, 2026
View details →Exactech, inc.
High PriorityActive
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Impactor handle may be missing cross-pin
Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Information Spreadsheet for details)
Mar 18, 2026
View details →Beckman coulter mishima k.k.
High PriorityActive
DxC 700 AU, REF: B86444, B86446
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.
REF/UDI-DI/Serial Numbers: Newer Instrument Installed with PC preinstalled with Microsoft SQL Server 2022 Express: B86444/14987666542545/2025060063, 2025060073, 2025060074, 2025060075, 2025060079, 2025060085, 2025060086, 2025060087, 2025060091, 2025060098, 2025060099, 2025060124, 2025060125, 2025060126, 2025060127, 2025060128, 2025060129, 2025070139, 2025070156, 2025070159, 2025070160, 2025070161, 2025070164, 2025070167, 2025070168, 2025070169, 2025070178, 2025070180, 2025070181, 2025070182, 2025070184, 2025070186, 2025070191, 2025070192, 2025070193, 2025070194, 2025070204, 2025080208, 2025080217, 2025080219, 2025080236, 2025080237, 2025080238, 2025080241, 2025080242, 2025080246, 2025080247, 2025080250, 2025090266, 2025090267, 2025090270, 2025090271, 2025090273, 2025090274, 2025090275, 2025090281, 2025090283, 2025090285, 2025090286, 2025090287, 2025090289, 2025090290, 2025090291, 2025090292, 2025090293, 2025090294, 2025090295, 2025090296, 2025090297, 2025090298, 2025090299, 2025090301, 2025090302, 2025090303, 2025090304, 2025090306, 2025100370, 2025100371, 2025100372, 2025100373, 2025100421, 2025100422, 2025100423, 2025100424, 2025100425, 2025100426, 2025100427, 2025110428, 2025110429, 2025110437, 2025110442, 2025110445, 2025110452, 2025110454, 2025110456, 2025110457, 2025110458, 2025110462, 2025120464, 2025120468, 2025120469, 2025120471, 2025120475, 2025120477, 2025120478, 2025120479, 2025120480, 2025120482, 2025120483, 2025120484, 2025120485, 2025120486, 2025120487, 2025120488, 2025120489, 2025120490, 2025120492, 2025120493, 2025120494, 2025120495, 2025120496. B86446/14987666542514/2025090277, 2025090284. Older Instrument Replaced with PC preinstalled with Microsoft SQL Server 2022 Express: B86444/14987666542545/2017050064, 2017100174, 2018030312, 2018040352, 2018100561, 2018110599, 2019010712, 2019010713, 2019111170, 2021021852, 2021102318, 2021122458, 2022042631, 2022052705, 2022062775, 2023063701, 2024064408, 2024064419, 2024064440
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No. 00055445008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Lot Code: Part number: 00055445008; UDI: 08426950807797; Lots No.: 251103J, 251110AF, 251111O, 251117AD, 251201AJ, 251202P, 251202Q, 251215K.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Model No. 00055430010.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055430010; UDI: 08426950807759; Lots No.: 251021K, 251027AA, 251110AH, 251114K, 251114O, 251114P, 251114Y, 251117AA, 251117AC, 251117AG, 251117AM, 251117AN, 251117P, 251117T, 251117V, 251117Y, 251118A, 251118B, 251118R, 251118X, 251119A, 251120R, 251120U, 251121Q, 251124O, 251124Q, 251125I, 251126S, 251126T, 251126U, 251201W, 251201X, 251202G, 251202H, 251203L, 251204R, 251205L, 251208N, 251211W, 251215D, 251215Z, 251216O, 251216S, 251217L, 251217V, 251218AB, 251218B, 251218X, 251218Y, 251219A, 251219O, 251222AE, 251222E, 251222F, 251222K, 251222M, 251222P, 251222Z, 251223A, 251223B, 251223C, 251223I, 251223M, 251223O, 251229D, 251229E, 251229I, 251229S, 251231B, 251231G.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000 PAK; Part No. 00055407511.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055407511; UDI: 08426950807643; Lots No. 251114K, 251201X, 251215D.
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
The device does not bear a unique device identifier.
UDI-DI: 0085007365404; Serial Numbers: 02216037601 03246681301 11193096501 07216136901 07216138701 02256869801 03246682501 11182940901 11193101101 03226290001 03226290002 01162459901 01203113001 01203113002 01203113003 07203175801 07203175801 01226258801 10226408401 03203144501 11246797902 09226392901 05246713601 03236484701 09203194901 02203122501 02203122502 02203122503 02203122504 02203122601 02203122602 02203122603 02203122604 11226426701 03203142501 03203142502 05203157501 05203157502 05203157503 05203157601 05203157602 05203157603 05203157604 05203157504 10193084101 09226392902 05193018501 08203193401 08203193402 08203193403 07216151601 07216151601 02256888101 01256839901 06236541501 10152425602 06216119401 12182945101 09182915101 08246758501 11182940902 11193101101 10246773801 01203111201 01216046301 02203130401 03192992401 12182948001 05193021901 11216226301 02203136301 01246652801 01203122501 01203122502 01203122503 01203122504 01203122601 01203122602 01203122603 01203122604 10193084001 09182915901 09182915902 09193066701 05236514701 03226301001 12236630301 12236630303 04226315101 10193084002 10182927201 10193082701 12182946801 08193059801 02226274001 01192967301 11193099201 07203179601 01203114201 11246792901 11246790701 11246790703 02226274201 02226274202 02226274203 08236568601 03226289804 06193009601 06193009602 01192956301 09193071501 0919371501 08203190801 08182901101 08182901102 08182901103 04216090901 02236473201 12246806301 06216121801 06216121802 06216121803 06216121804 06216121805 06216121806 10216191301 10182930001 02203137801 07236553801 12216232501 12216232503 01256840201 03236489601 03236489603 05193018701 03192986401 06226336201 11193098201 07216145901 10203210901 05193020101 05193020201 01192967401 01236449801 09193068001 08216157101 05203162001 06203164901 12236631201 09203199501 08203193601 06193031201 01192958901 11182936701 08182900501 08182900502 09193723010 09193723020 06193037201 06226338401 06226338402 05236516301 01246647401 02203131901 10193083101 09226388401 01216015501 04246699001 04246699002 04246699003 06203170401 12182947801 04193006501 08203185601 11216214101 10182930901 12236633401 12236633402 09193068601 12236633601 09182913801 09182913802 02246673601 05182851401 10226412301 05246713201 09182915201 03226287701 12193109801 06236537701 06236537702 06236537703 06236537704 08236571901 08236563101 07216152701 01236452801 05203156601 10203212601 10203212602 10203212603 10203212604 02256869801 03256916201 03256923701 03256923702
Mar 18, 2026
View details →Medartis ag
High PriorityActive
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Lot Code: Version or Model: A-5750.16/1 Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000 PAK; Part No. 00055360008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055360008; UDI: 08426950807575; Lot No. 251021P, 251113U, 251117AD, 251204T, 251222U, 251223E, 251229AG, 251229X.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No. 00055415008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055415008; UDI: 08426950807674; Lots No. 251021P, 251106X, 251110AF, 251111O, 251113J, 251113V, 251117AD, 251118D, 251124Z, 251126Q, 251201AJ, 251202P, 251204T, 251212N, 251215J, 251215K, 251223E, 251229AG, 251229X.
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
The device does not bear a unique device identifier.
UDI-DI: 0085007365402; Serial Numbers: 03203147501 01192957001 06203171301 07203175701 11162597701 11193074801 11193074802 09193074801 09193074802 09193074803
Mar 18, 2026
View details →Physio-control, inc.
High PriorityActive
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).
Due to pediatric defibrillator electrode delamination
Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Lot Numbers: 315303, 315639, 315858, 316007, 320529, 318931
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000 PAK; Part No. 00055407510.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055407510; UDI: 08426950807636; Lots No.: 251114J, 251117AC, 251117T, 251118B, 251119B, 251121P, 251124O, 251124Q, 251126E, 251201U, 251201V, 251201W, 251202G, 251203H, 251203L, 251204N, 251204O, 251205L, 251208I, 251208J, 251215Y, 251215Z, 251216V, 251217L, 251217X, 251218AA, 251218Y, 251219G, 251219M, 251219N, 251219S, 251222E, 251223D, 251223I, 251223N, 251223O, 251229J, 251229L, 251229U, 251231E.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000 PAK; Part No. 00055360011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055360011; UDI: 08426950807605; Lots No.: 251119A.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000 PAK; Part No. 00055407508.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055407508; UDI: 08426950807612; Lots No.: 251021P, 251106X, 251110AF, 251201AJ, 251202P, 251209S, 251212N, 251215J, 251218W, 251219A, 251223E, 251223M, 251223P, 251229X, 260102F.
Mar 18, 2026
View details →Trividia health, inc.
High PriorityActive
Owner's Booklets and Instructions for Use that are used with the
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Device Item/UDI-DI: RF4001-01BK/311917178691, RF4007-01/50428560402, RF4019-01/708820721098, RF4023-01/21292009335, RF4031-01/41220136131, RF4048-01/75450843576, RF4066-01/11822002783, RF4209-01/36800234567, RF4H01-01BK/21292006112, RF4H01-40/21292009793. International: RF4i29-11BK/N/A, RF4i81-11BK/N/A, RF4i82-11BK/21292012229, RF4i82-12BK/21292009984. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX GO Owner's Booklet/ RF4TVH03 Rev 57 and prior, TRUE METRIX GO Owner's Booklet (English)/RF4TVH35 Rev 51 and prior, TRUE METRIX GO Owner's Booklet (Spanish)/RF4TVH35S Rev 51 and prior, TRUE METRIX GO Blood Glucose Monitoring System IFU Trividia House Brand/ RF4ITV16 Rev 55 and prior, TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health UK Limited/ RF4UKT16 Rev 56 and prior, Trividia Health LATAM- TRUE METRIX GO System IFU/ RF4LAT16 Rev 51 and prior, TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health Australia/ RF4AUT16 Rev 57 and prior,
Mar 18, 2026
View details →Kob gmbh
High PriorityActive
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
Model/Catalog Number: NONUNNAS40 KOB article #40307010 Customer Code: (01)10888277675438 Lot Numbers: 2520206 2520739
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No. 00055445004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055445004; UDI: 08426950807773; Lots No. 251111O, 251117AD, 251124Z, 251125S, 251202P, 251204T, 251208AA, 251212O, 251216K, 251217I, 251223E, 251229AG, 251229X, 251230P.
Mar 18, 2026
View details →International life sciences
High PriorityActive
Artelon FlexBand Plus Ref: 41054 & 41057
Augmentation devices failed bacterial endotoxin testing.
REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB
The device does not bear a unique device identifier.
UDI-DI: 0085007365401; Serial Numbers: 12193105601 09246762101 09246762102 07203174301 07205587001 12236633201 12236633202 09216175802 09216175801 05226320101 05216099201 05216099202 10216200701 01203114101 10193088201 10193088202 05205560701 05205559901 07216148001 07216148002 02226267201 02226267202 06246721701 06246721702 05236523001 05236523002 05236523003 03216064601 03216064602 09185135701 09185135702 11246790502 11246790501 04236501905 04236501902 04236501901 04236501904 07226354201 01236448201 01236448202 01236448203 01236448204 01236448205 01236448206 01236448207 01236448208 08142214601 08236570201 05226328502 05226328501 05226328504 05226328505 11195429001 11195429101 09246761301 09246761302 08185103701 01226253101 08195355001 09205628901 09205629001 08246753101 08246753104 08246753105 08246753106 08246753102 08246753103 02236477101 10182928001 10185152601 10236608401 10236608402 09195378101 09195378001 09195378301 09195378201 11195442101 11195442201 06246726708 06246726707 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09205631601 05216102601 06216120601 01226249601 04195281001 04195281101 01256821601 01256821602 04236503601 04236503602 04226311501 04226311502 12236630701 12236630702 07246742101 04246689802 03226286001 03226286002 03226286003 03226286004 10246788801 10246788802 03040570501 08195369001 08195369101 11226431101 11226431102 11226431103 11226431104 11226431105 11226431106 06246720301 10193078501 11193091301 03192999001 03226289802 03226289801 11195423001 02195222201 04195277701 02195222302 06195320201 01246656901 01246656902 01226252301 01226252302 04226310001 04226310002 04226310003 04226310004 04226310005 04226310006 09226395103 09226395104 09226395102 09226395101 08246758701 08246758702 08236566001 08236566002 06236541703 06236541702 06236541704 06236541701 05246709101 05246709102 08236573801 08236573802 08236573803 08236573804 08236573701 08236573702 08236573703 01192956501 01256823302 01256823307 01256823301 01256823304 01256823305 12246806101 01226253401 01226253402 11195431901 11195431902 11195432001 11195432002 01236450802 05216106001 05216106002 07216145201 12246805901 12246805902 08216170601 08216170602 07246746701 07246746702 07246746703 07246746704 04246701101 04246701102 04205538101 04205538201 08195370401 08195370601 08195370501 08195370701 10246775801 10246775802 03203144301 03203144302 03203144303 07205593201 07205593301 04226309001 04226309002 04226309003 04226309004 02236467101 02236467102 08216171303 08216171301 08216171304 08216171302 11195422701 08246749702 11246797701 11246797702 08246749701 03226294601 03226294602 08236559301 08236559302 08236559303 08236559304 09236590701 09236590702 09236590703 09236590704 03205525201 02205492701 02205492801 08154129101 07195347301 07236546201 05226321701 05226321702 05226321703 02246661601 02246661602 02246661603 02246661604 08246752901 02205500401 02205500201 02205500501 02205500301 08205606701 08205606601 01216007301 01216007302 11195432101 11195432201 08246749502 08246749501 04226303001 04226303002 11205678301 11205678401 03226293401 03226293402 04226303902 04195287001 04195287101 10226407601 04246700801 04246689801 04246700802 10216192701 10216192702 10226409501 01236449001 11226422702 11226422701 08193063201 08195370801 06185058701 04236511501 04236511502 09226386201 09226386202 02256869601 02256869602 02226268101 08203186701 08203186702 11195441701 11195441601 09205631701 09205631801 11216226601 11216226602 01195206601 01192969601 01195214901 08205621101 08205621301 08205621201 08205621401 11195432501 11195432301 10185160201 10185160301 10236601101 10236601102 01205478601 01205478501 01195194601 01195194602 01195194701 01195194702 01195194801 01195194802 01195194803 01195194804 03195253201 03195253101 12193111001 12193111002 12193111003 03256913101 04226313201 04226313202 03205534201 03205534301 06246730901 03216068002 03216068001 10236603601 10236603602 10195399001 04236513401 07246745801 07246745802 09185131501 12185174101 05226329701 05226329702 05236525201 03226288201 03226288204 03226288202 03226288205 01226247301 05236518401 05236518402 01203113501 07216142303 07216142301 07216142302 07216142304 08226381501 01236450803 01236450804 02236475901 01205459301 01205488501 01205488601 03236481701 03236481702 05195305101 10226419201 10226419202 10226419203 10226419204 06216118101 06216118102 05195305001 09193065201 09193065202 06091887401 07236552001 07236548401 06226352201 06226352202 10226406501 10226406502 04226303901 07205596401 06205578501 06205578601 09226390201 09226390202 10216202801 10216202802 01205488701 01205488702 08216158601 08216158602 01226249801 11195429201 11195429301 03216073502 01195189901 01195190001 01246648501 03195260601 08226368401 08226368402 01216023301 01216023302 11203219901 04091852502 04205547101 04205547201 04205548901 04205549001 04226308001 04226308002 01246652401 01246652402 10246776001 10246776003 06205586201 06205586301 10236598301 11246800501 11246800502 12226440301 05246715901 05246715902 08226376401 08226376402 05216103301 05216103302 03195242101 04195276901 01246647801 07246746102 07246746101 12236632401 12236632402 03195243601 03195243701 03226297701 08226367701 08226367702 04246698501 04226317901 04226317902 09236588001 09236588003 04205535201 02195229701 02195229801 11236623101 11236623104 11236623102 11236623105 09216180701 09216180702 09216180703 09216180704 09216180705 09216180706 09216180707 09216180708 09216180709 09216180710 09216180711 04195273701 04195273801 06236528401 06236528402 04205551101 10205665401 10205665402 10205665403 10205666501 10205666502 10205666503 05216112601 05216112602 02226275101 02226275102 02226275103 02226275104 02226275105 02226275106 02256870201 02256870202 09246770001 03256932701 03256932702 03256913501 03256944901 03256944902 04256970102
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No: 00055415011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055415011; UDI: 08426950807704; Lots No.: 251215D.
Mar 18, 2026
View details →Trividia health, inc.
High PriorityActive
Owner's Booklets and Instructions for Use that are used with the
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Device Item/UDI-DI: RE4001-01/00311917166896, RE4002-01/96295126600, RE4002-40/96295126655, RE4007-01SB/50428275283, RE4011-00/87701426520, RE4011-01/87701426254, RE4019-01/713733069816, RE4023-01/21292007256, RE4025-01/93351018992, RE4027-01/21292007065, RE4031-01/41220001286, RE4051-43/20612479197231, RE4054-00/10939722447, RE4054-01/10939719447, RE4060-01/321130788669, RE4061-01/41520147745, RE4066-01/11822445610, RE4078-40/21292007614, RE4081-03/21292014797, RE4087-01/77890394113, RE4089-00/52569138557, RE4089-01/52569138526, RE4095-40/21292007041, RE4097-01/725439988933, RE4098-01/21292008901, RE4099-40/21292014902, RE4099-45/21292008697, RE4202-43/21292007454, RE4203-01/41260016028, RE4209-01/36800234529, RE4211-01/10939958693, RE4H01-00/21292006082, RE4H01-01/21292006051, RE4H01-04/21292008895, RE4H01-40/21292006068, RE4H01-43/21292006075, RE4H01-51/21292014940. International: RE4i01-00/N/A, RE4i01-01/N/A, RE4i01-02/N/A, RE4i03-02/N/A, RE4i03-11/N/A, RE4i05-00/N/A, RE4i07-00/N/A, RE4i23-00/21292010133, RE4i29-11/N/A, RE4i61-02/N/A, RE4i61-02THI/N/A, RE4i82-11/21292012205, RE4i82-12/21292009977. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX Owner's Booklet/ RE4TVH03 Rev 56 and prior, TRUE METRIX Owner's Booklet (English)/ RE4TVH35 Rev 51 and prior, TRUE METRIX Owner's Booklet (Spanish)/ RE4TVH35S Rev 51 and prior, McKesson Med Surg TRUE METRIX Self Monitoring Owners Booklet/ RE4SUN03 Rev 55 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior, TRUE METRIX Blood Glucose Monitoring System IFU Trividia House Brand/ RE4ITV16 Rev 53 and prior, TRUE METRIX System Instructions for Use (IFU) for Trividia Health UK Limited/RE4UKT16 Rev 55 and prior, Trividia Health LATAM - TRUE METRIX System IFU mg/dL/ RE4LAT16 Rev 50 and prior, TRUE METRIX System Instructions for Use (IFU) for Trividia Health Australia/ RE4AUT16 Rev 56 and prior.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No. 00055415010.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055415010; UDI: 08426950807698; Lots No.: 251114J, 251114K, 251114L, 251117AA, 251117F, 251117I, 251117L, 251117T, 251118A, 251118B, 251118C, 251119A, 251119B, 251124K, 251126D, 251126M, 251126N, 251126U, 251201V, 251202E, 251202F, 251203L, 251204N, 251204R, 251205L, 251208J, 251211V, 251211W, 251215D, 251215W, 251216O, 251216W, 251217V, 251219A, 251219B, 251219N, 251219O, 251219P, 251219Q, 251219S, 251222AD, 251222AF, 251223D, 251229AL, 251229I, 251229K, 251229U, 251230A, 251230S, 251231B, 251231E, 251231I, 260102D, 260105A.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No. 00055430004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055430004; UDI: 08426950807711; Lots No.: 251111O, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251201AJ, 251202P, 251203Q, 251208AA, 251212O, 251215J, 251216K, 251217I, 251217J, 251218V, 251219R, 251222T, 251222U, 251223E, 251223P, 251229AG, 251229X, 251230P.
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
The device does not bear a unique device identifier.
UDI-DI: 0085007365405; Serial Numbers: 07246739501 07216139901 02192979601 11182940903 12193105501 09185135601 09185135602 11246797901 05236523801 08236568901 08236568902 11216211801 10226408001 10226408002 06193032901 04246699301 04246699302 06226346001 03192988001 05193026301 08182896501 08182896502 08182896503 08182896504 05216110201 06246732101 06246732102 05193020401 11216226901 09246768801 11203215901 09182915601 04193013701 01203113401 10246774001 09193066801 07226353001 07226359101 01256834801 08236567401 11236611101 11226430001 02246665701 10182930801 03246680001 01192960601 03236486401 06236533901 05236526702 09216179201 10193089801 06236532901 06236532902 06236532903 08182902101 03192995801 03192995802 09193067401 07205595301 04216084401 04193002001 04193002002 11216213101 11182939701 09193074901 09193074902 01236449501 01236449502 03192987401 03203142901 03203142902 02192981501 02192981502 05226324701 03226296101 09203198701 04246693301 07226356501 04216092701 04236503401 11236613601 11236613602 02226270303 04226309007 04226309008 01246648301 01246648302 06081036001 03203140001 03203140002 03205525101 07226356201 03216055401 04193000001 11203216801 11203216802 07193044101 01203116101 01203116102 01203116103 05246713401 05246713402 07246738901 07193050501 10246777701 12226443001 11226427301 05216098101 11226433501 09226401501 08216173101 08216173102 05203162501 06226339001 06226339002 05193018601 04216081201 11182933201 11182933202 11236611301 09236584601 09236584602 07193042101 12182947701 01256823701 10226421501 01256838101 04216081901 10226417301 09193071201 02246672301 07205596301 12236524501 11193098801 03216073501 01256852601 10246788401 02226266601 03192998901 12182946201 10236598101 05193023401 05193023402 01226261601 02203131401 03192987901 03192987902 03192987903 02246671801 04246704401 06203167601 07246745601 07216151101 10195414701 01236457001 06193029401 06193029402 04256970101
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
The device does not bear a unique device identifier.
UDI-DI: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201
Mar 18, 2026
View details →Exactech, inc.
High PriorityActive
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Impactor handle may be missing cross-pin
All Lots/ UDI-DI: 10885862559166
Mar 18, 2026
View details →International life sciences
High PriorityActive
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Augmentation devices failed bacterial endotoxin testing.
Lot: RK29976/GTIN: 00850003396248
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
The device does not bear a unique device identifier.
UDI-DI: 0085007365408; Serial Numbers: 08216172001 07205587101 09195387501 06216130401 06226336703 03226285001 07205587102 07205587102 10216194401 05205566901 08205620801 08246753903 06226345801 05216107103 08216170401 08195374901 09205629101 02226268801 05216098901 05246710101 04226317301 01226251403 08195367701 02226274601 08195367501 11226430901 10246773202 10246778301 02205500703 12195458301 03226297101 10205654401 10205654402 10246773201 01236457201 10195408001 05216106401 11216217002 06226336702 02256885901 10246776501 01205470801 02205500701 02216027601 09195396901 02236474901 02216042601 06246726801 01205470701 01236457202 02226268802 04216087001 03236497001 02246658801 07205601501 09216184102 10205654302 11216217001 04205552801 08195374801 03205534001 05205553001 05205553002 07205605501 07205605502 07205605503 07205605504 07205605505 02226278501 03236482501 01246639801 01246651201 01246651202 11236614902 08195367801 01226251401 09205628801 06216115102 09216184103 08246752402 11226432201 02256890001 09246763202 09246767901 09246767902 08216167602 04246689601 11246799301 11205673701 12226438801 06216132401 06216132402 07216147101 09216184101 11216212801 09205638801 09236593102 01246654601 01256819701 01256858401 11246799302 07226367202 02246663102 04205552701 01205488401 04246702501 12246803401 04226309009 06246728901 06216130301 09205633201 04216094201 12226445201 08216167601 11205674401 06226337201 09246763201 10205659001 09226400901 09236593101 10205658101 09226387902 02205504901 04205552902 05216101101 05226330401 04246702501 01256858402 03256936501 10205653401 10205654301 01236461401 12236627901 04236504902 12226441901 05226330402 05216107101 10205653402 01216010402 05236517801 02236464701 03246677401 04236504901 07236550501 12195443001 02236478301 11226426301 01205479701 03205534101 01226251402 08236577101 09226387901 07246737901 10246787801 06205578701 06205578702 01226262601 08203185603 08236579201 02205500702 10226420401 08246752401 11216222502 08195368801 10216194402 08236572401 03236492701 07216150101 09226390101 03205517901 03226285002 07216150102 06216130302 10246789501 09226387903 09216176801 08246753901 06216115101 04205552901 11216210801 08195374902 04205552702 08226367703 02205504501 12216230701 08236579202 08216167603 03256906001 04256955501 03256908201
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-0027/15; UDI-DI: 04026575432127; Serial/Lot Number: 2549190;
Mar 18, 2026
View details →Altruan gmbh
High PriorityActive
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Product not cleared by the FDA.
Model No. SP-C310343-10; No UDI; Lot Code: 01242573.
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
The device does not bear a unique device identifier.
UDI-DI: 0085007365400; Serial Numbers: 06020315401 08010223607 04205543401 05246707501 05246707502 02195222101 11216213301 09185118801 10216206001 10216206002 11216222201 11216222202 05246717201 02195236901 11195422801 01246647601 01246656501 04205544901 12205685701 09236590301 11195432401
Mar 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
UDI-DI (each/case) 10197344014002 20197344014009 10888277189188 40888277189189 10884389189191 40884389189192 10884389193297 40884389193298 10888277189218 40888277189219 10884389189221 40884389189222 10193489040111 20193489040118 10884389189221 40884389189222 10193489021820 20193489021827 All lots affected
Mar 18, 2026
View details →Covidien llc
High PriorityActive
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN); 10884521844933 Serial Number: Vital Sync 3.3.1 CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521844940 Serial Number: Vital Sync 3.4.0 CFN: VSLBASE03P / VITALSYNCSW03 (OUS only) UDI-DI (GTIN): 10884521847569 Serial Number: Vital Sync 3.4.1 CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521856127 Serial Number: Vital Sync 3.4.2 CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521849358 Serial Number: Vital Sync 4.0.1 CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521856134 Serial Number: Vital Sync 4.0.2
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 860010-1L
The device does not bear a unique device identifier.
UDI-DI: 0085007365409; Serial Numbers: 07246737902 10236603401 10226407101 03236488101 03246677601 08226379901 08226385601 12236632601 07226353601 08236572201 04246696501 01256844001 12246811601 06226337201 07236557301 09236582001 02246663101 09246761901 08226369401 08226374601 01246644601 04246691701 08246756001 10236600001 04256958001 04256952001
Mar 18, 2026
View details →Becton dickinson & company
High PriorityActive
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Catalog Number: 301029., UDI-DI: N/A. Lot Number: 5268614. Expiration Date: 08/31/2030.
Mar 18, 2026
View details →Ion beam applications s.a.
High PriorityActive
IBA Proton Therapy System - PROTEUS 235
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-2835/12; UDI-DI: 04026575316564; Serial/Lot Number: 241210/1809;
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-2836/11; UDI-DI: 04026575316571; Serial/Lot Number: 250623/3643, 250623/3644, 250623/3645, 250623/3646, 250623/3648, 250812/2812, 250812/2811;
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000 PAK; Part No. 00055415004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055415004; UDI: 08426950807650; Lots No.: 251111O, 251112P, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251202Q, 251203Q, 251208AA, 251209T, 251212O, 251216K, 251217I, 251217J, 251219R, 251222U, 251223E, 251229AG, 251229X, 251230P, 260102F.
Mar 18, 2026
View details →Altruan gmbh
High PriorityActive
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Product not cleared by the FDA.
Model No. AL-42153; No UDI; Lot Code: 6952804827274.
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No. 00055430011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055430011; UDI: 08426950807766; Lots No.: 251114K, 251205K, 251215D.
Mar 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
UDI-DI (each/case) 10193489036961 20193489036968 10193489036978 20193489036975 10193489040098 20193489040095 10193489036954 20193489036951 10193489036985 20193489036982 All lots affected
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000; Part No. 00055445010 & 00055445011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055445010; UDI: 08426950807810; Lots No.: 251023N, 251024J, 251114K, 251117A, 251117AC, 251117AE, 251117F, 251117I, 251117J, 251117Y, 251118A, 251119A, 251120U, 251121Q, 251121S, 251121T, 251121W, 251121X, 251124K, 251124O, 251124U, 251125I, 251126C, 251126D, 251202H, 251203L, 251203M, 251204R, 251204S, 251205K, 251205L, 251208J, 251208L, 251215D, 251215W, 251215X, 251216S, 251216V, 251217W, 251217X, 251218R, 251218Y, 251219B, 251219C, 251219E, 251219H, 251219I, 251219P, 251219Q, 251223B, 251223D, 251223F, 251223K, 251229AL, 251229D, 251229E, 251229F, 251229S, 251229U, 251230R, 251231B, 251231D, 251231E, 251231H, 251231M. Part number: 00055445011 UDI: 08426950807827 Kits distributed in US: 96 Lots No.: 251117L, 251118O, 251124K, 251125I, 251201X, 251202G, 251203M, 251204O, 251223K, 251229W, 251230A.
Mar 18, 2026
View details →Penner patient care, inc.
High PriorityActive
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
The device does not bear a unique device identifier.
UDI-DI: 0085007365406; Serial Numbers: 11185169701 01205459101 09236589001 08226376601 05236519007 07154096101 09185123501 09205645001 06216123501 06216123502 06216123503 04246695301 05205559701 05226325001 05226333501 03216074601 03216074602 03216074603 03216074604 04195277301 04216084201 05246707001 06195314201 03256918201 03256945401
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000 PAK; Part No. 00055360010.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Part number: 00055360010; UDI: 08426950807599; Lots No.: 251023N, 251024I, 251103I, 251117T, 251118B, 251120R, 251124O, 251126E, 251201X, 251202E, 251202G, 251203H, 251204O, 251205L, 251205N, 251208C, 251208G, 251209Q, 251209R, 251215Y, 251217V, 251218AA, 251218T, 251219M, 251222AE, 251222AF, 251222AG, 251222E, 251222F, 251223R, 251223S, 251229H, 251229J, 251229U, 251230A, 251231E, 251231K, 251231L.
Mar 18, 2026
View details →Medartis ag
High PriorityActive
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Lot Code: Version or Model: A-5850.16/1 Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933
Mar 18, 2026
View details →Altruan gmbh
High PriorityActive
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Product not cleared by the FDA.
Model No. 41972; No UDI; Lot Code: 6933289812337.
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-0027/12; UDI-DI: 04026575431960; Serial/Lot Number: 2549036;
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 16-2840/02; UDI-DI: 04026575359233; Serial/Lot Number: 250925/0640 , 250925/0641, 250925/0642, 250925/0646, 250925/0650, 250925/0652, 250925/0653 , 250925/0656, 250925/0658, 250925/0669, 250925/0670, 250925/0680, 250925/0681 , 250925/0682, 250925/0687, 250925/0689, 250925/0690, 250925/0691, 250925/0693 , 250925/0694, 251110/3293, 250925/0660, 250925/0661, 250925/0684, 250925/0685 , 250925/0657, 250925/0663, 250925/0659, 250925/0678, 251110/3288, 251110/3292 , 251110/3303, 251110/3313, 250925/0683, 250925/0674, 250925/0644, 250925/0665 , 250925/0668, 250925/0671, 250925/0673, 250925/0676, 250925/0664 , 250925/0651 , 251110/3297, 251110/3289, 250925/0639, 250925/0648, 250925/0688, 250925/0696;
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-8521/09; UDI-DI: 04026575383238; Serial/Lot Number: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045;
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Number: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227;
Mar 18, 2026
View details →Boston scientific corporation
High PriorityActive
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; Outer Box UDI: 08714729880394; Inner Box UDI: 08714729880387; Outer Box Lot#s: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292; Inner Box Lot#s: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840, 37583642, 37731897;
Mar 18, 2026
View details →Waldemar link gmbh & co. kg (mfg site)
High PriorityActive
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Item Number: 15-0027/16; UDI-DI: 04026575432134; Serial/Lot Number: 2550412, 2550413, 2549228;
Mar 18, 2026
View details →Instrumentation laboratory
High PriorityActive
GEM Premier 5000 PAK; Part No. 00055407504.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Lot Code: Part number: 00055407504; UDI: 08426950807537; Lots No.: 251111O, 251112P, 251113U, 251114T, 251117AD, 251118D, 251119D, 251120X, 251125S, 251126Q, 251201AI, 251202Q, 251203Q, 251204T, 251209T, 251212O, 251215K, 251216K, 251217I, 251218U, 251219R, 251222U, 251223E, 251223P, 251229AG, 251229X, 251230P, 251231F.
Mar 18, 2026
View details →Agiliti health - ellis
High PriorityActive
Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.
UDI-DI 0084569904914; All serial numbers with a manufacturing date prior to 12/04/2025
Mar 4, 2026
View details →Hitachi, ltd. radiation oncology systems, kashiwanoha
High PriorityActive
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Software anomaly in the patient positioning system may result in positional discrepancy.
Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
SKU DYNDA2705 UDI-DI (ea) 10193489468632 UDI-DI (case) 40193489468633 Kit lots 24DBL787 24HBR630 25ABH699 25DBV209 25GBQ405 SKU DYNJ63347A UDI-DI (ea) 10193489278064 UDI-DI (case) 40193489278065 Kit lots 24AMC874 24AME139 24AMH820 24BMF097 24CMF691 24GMB769 24GMK036 24IMC124 24LMA110 25AMJ634 25GMD386 25IMB510 25JMI708
Mar 4, 2026
View details →Edermy llc
High PriorityActive
PIE Trolley System Model: 2005
Lack of 510K clearance
All Lots
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. WA22017T; UDI: 04042761051521; All Lots.
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
1) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBS147; 2) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBJ329; 3) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25ABU209; 4) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBJ364; 5) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBB718; 6) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23JBV524; 7) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBU998; 8) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBF119
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
UDI-DI (ea) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A22041T; UDI: 04042761020978; All Lots.
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A UDI-DI (ea) 10653160383628 UDI-DI (case) 00653160383621 Kit lots 2024121390 2025033190 Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 UDI-DI (ea) 10653160368755 UDI-DI (case) 00653160368758 Kit lot 2025041090 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A UDI-DI (ea) 10653160374978 UDI-DI (case) 00653160374971 Kit lots 2024051490 2025021290 2025051390 2025091090 Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 UDI-DI (ea) 10653160375845 UDI-DI (case) 00653160375848 Kit lots 2024060690 2024101690 2024103190 2025010890 2025040190 Medline DIALYSIS CHANGE KIT SKU EBSI1453A UDI-DI (ea) 10653160383475 UDI-DI (case) 00653160383478 Kit lots 2024050790 2024051390 2024082290 2024111990 2025013090 2025032090 2025050190 2025062790 Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 UDI-DI (ea) 10653160368922 UDI-DI (case) 00653160368925 Kit lots 2025040401 2025081401 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741 UDI-DI (ea) 10653160374527 UDI-DI (case) 00653160374520 Kit lots 2024061780 2024070180 2024081280 2024111290 2025012490 2025032690 2025051390 2025061790 2025071490 2025072190
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A22043T; UDI: 04042761021012; All Lots.
Mar 4, 2026
View details →Natus medical denmark aps
Low PriorityActive
Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe Recall
Recalls and safety alerts
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A37004A; UDI: 04042761023092; All Lots.
Mar 4, 2026
View details →Mrimed inc.
High PriorityActive
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Model Number: SL-111 UDI-DI code: Pending Information Serial/Lot Numbers: 23-12-074 23-12-039 0 2006001 2006002 2006004 2006005 2006006 2006007 2006008 2006009 2006011 2006012 2006013 2006014 2006015 2006016 2006017 2006018 2006020 2006021 2006023 2006024 2006026 2006027 2006028 2006029 2006030 2006031 2006031 2006032 2006033 2006034 2006035 2006038 2006039 2006040 2006043 2204028 2204047 2206001 2206003 2206004 2206005 2206006 2206009 2206010 2206011 2206012 2206013 2206014 2206015 2206016 2206017 2206018 2206019 2206020 2206021 2206022 2206024 2206026 2206027 2206029 2206030 2206033 2206034 2206036 2206037 2206038 2206040 2206042 2206043 2206044 2206045 2206046 2206048 2206049 2206050 2206052 2206053 2206054 2206055 2206056 2206057 2206058 2206059 2206060 2206062 2206063 2206064 2206065 2206066 2206067 2206068 2206069 2206070 2206071 2206072 2206073 2206074 2206075 2206076 2206077 2206079 2206080 2206081 2206082 2206083 2206084 2206085 2206086 2206087 2206088 2206090 2206092 2206093 2206094 2206095 2206096 2206097 2206098 2206099 2206100 2301228 2311040 2311058 2312001 2312002 2312003 2312004 2312005 2312006 2312007 2312008 2312009 2312010 2312011 2312012 2312013 2312014 2312015 2312016 2312018 2312019 2312020 2312021 2312022 2312023 2312024 2312025 2312026 2312027 2312029 2312030 2312031 2312033 2312034 2312035 2312036 2312036 2312037 2312038 2312039 2312041 2312041 2312042 2312044 2312045 2312047 2312049 2312050 2312051 2312052 2312053 2312054 2312055 2312056 2312057 2312058 2312059 2312060 2312061 2312062 2312064 2312065 2312066 2312067 2312068 2312070 2312071 2312072 2312074 2312075 2312076 2312077 2312078 2312079 2312080 2312080 2312081 2312082 2312082 2312083 2312084 2312087 2312089 2312090 2504001 2504003 2504004 2504005 2504006 2504007 2504008 2504010 2504011 2504013 2504014 2504015 2504016 2504017 2504018 2504021 2504022 2504025 2504026 2504029 2504030 2504031 2504032 2504035 2504036 2504038 2504039 2504040 2504044 2504047 2504049 2504050 2504051 2504054 2504055 2504056 2504058 2504059 2504068 2504072 2504073 2504075 (The serial number for this light has been confirmed as 2006025 and was switched in the records with row 312 (Evertett clinic). 20 06 044 2006025¿(account has confirmed serial as: 2006026 - 2006026 is listed as row 311 - Prince William Med Ctr) 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2006xxx 2206025; 2206023 2206089 & 2206078 2206xxx 2206xxx 2206xxx 2206xxx 2206xxx 2312xxx 2312xxx 2312xxx 2312xxx 2504xxx
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A22043A; UDI: 04042761021005; All Lots.
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A2660; UDI: 04042761004176; All Lots.
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A22042T; UDI: 04042761020992; All Lots.
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
UDI-DI (ea) 10653160373582 UDI-DI (case) 00653160373585 Kit lots 2024051380 2024052080 2024052180 2024052280 2024071580 2025061790 2025072990
Mar 4, 2026
View details →Encore medical, lp
High PriorityActive
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Knee and Humeral socket implants contain incorrect labeling.
Lot Code: Lot: 385P1263 GTIN: 00888912144575
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. WA22017A; UDI: 04042761051514; All Lots.
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A2641; UDI: 04042761004060; All Lots.
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A22040A; UDI: 04042761029339; All Lots.
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
1) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25BBO366; 2) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABI804; 3) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABF375; 4) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24JBL155; 5) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24IBG900; 6) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBT801; 7) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBC584; 8) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24DBB692; 9) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24BBL239; 10) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23KBO692; 11) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23IBT788; 12) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23HBJ026; 13) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23EBK780; 14) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23DBL149; 15) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23CBJ576
Mar 4, 2026
View details →Medtronic perfusion systems
High PriorityActive
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
UDI-DI: 00763000543693; Lot Number: 0232837110
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
IR PACK UDI-DI (ea) 10195327621780 UDI-DI (case) 40195327621781 Kit lots 24BBP627 24DBO029 24FBI148 24JBA858 24KBD925 24LBG978 25ABQ002 25EBV162; NO CATHETER DIALYSIS INSERTION UDI-DI (ea) 10195327675219 UDI-DI (case) 40195327675210 Kit Lots 24EBM915 24GBC287
Mar 4, 2026
View details →Encore medical, lp
High PriorityActive
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Knee and Humeral socket implants contain incorrect labeling.
Lot Code: Lot: 378P1382 GTIN: 00888912144544
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A4741; UDI: 04042761006514; All Lots.
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 UDI-DI (ea) 10193489111538 UDI-DI (case) 20193489111535 Kit lots 2024052090 2024072690 2024100390 2024121290 2025020490 2025041590 2025062790 2025090890 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 UDI-DI (ea) 10889942723508 UDI-DI (case) 40889942723509 Kit lots 2024051690 2024073190 2024092490 2024121190 2025020790 2025032790 2025052990 EBSI1596 UDI-DI (ea) 10653160357162 UDI-DI (case) 00653160357165 Kit lots 2024070190 2024082390 2024102390 2024121790 2025031090 2025040190 2025052790 2025072890 EBSI1781 UDI-DI (ea) 10653160379638 UDI-DI (case) 00653160379631 Kit lots 2024100490 2024123090 EBSI1812 UDI-DI (ea) 10653160386735 UDI-DI (case) 00653160386738 Kit lots 2025032190 2025052990 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 UDI-DI (ea) 10653160345343 UDI-DI (case) 00653160345346 Kit lots 2024050680 2024072980 2024090380 2024111290 2024121190 2025032890 2025061790 2025072390 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 UDI-DI (ea) 10193489199307 UDI-DI (case) 20193489199304 Kit lots 2024052080 2024070880 2024110490 2025010290 2025022090 2025030390 2025040990 2025072990 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845 UDI-DI (ea) 10653160355151 UDI-DI (case) 00653160355154 Kit lots 2024060790 2024080790 2024100990 2024112590 2025042490 2025082090
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A2666; UDI: 04042761004244; All Lots
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Model Number MJSALINE7 - UDI-DI: 00708820657052 (unit), 10708820657059 (case), All Lots
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A2666T; UDI: 04042761004251; All Lots.
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A42011A; UDI: 04042761023658; All Lots.
Mar 4, 2026
View details →Hitachi, ltd. radiation oncology systems, kashiwanoha
High PriorityActive
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Software anomaly in the patient positioning system may result in positional discrepancy.
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A22040T; UDI: 04042761029360; All Lots.
Mar 4, 2026
View details →Edermy llc
High PriorityActive
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Lack of 510K clearance
All Lots UDI:
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. Model No. A22041A; UDI: 04042761020961; All Lots.
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
Model: WA2280A; UDI: 04042761051729; Lot#: All lots;
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
1) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25JBG340; 2) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25EBV829; 3) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25CBM029; 4) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25BBI797; 5) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25ABW687; 6) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23EBN045; 7) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23DBM064; 8) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25HBB845; 9) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25GBS259; 10) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25DBR145; 11) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25BBS769; 12) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24KBJ466; 13) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24JBQ815; 14) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24IBU526; 15) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23IBJ540; 16) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23HBP844; 17) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23HBE308; 18) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23GBT102; 19) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 25DLA344; 20) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 25CLA657; 21) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 24GLB208; 22) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 24ELA332; 23) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBS451; 24) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBS450; 25) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBE908; 26) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBE909; 27) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25GBM037; 28) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25GBK565; 29) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25FBL177; 30) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25EBP727; 31) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25EBO749; 32) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBQ021; 33) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBD942; 34) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBA345; 35) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25BBU730; 36) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25BBS503; 37) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25ABM247; 38) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24KBN725; 39) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24KBE264; 40) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH956; 41) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH955; 42) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH957; 43) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24HBQ854; 44) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24HBO200; 45) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24GBN624; 46) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBH929; 47) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBG790; 48) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBD096; 49) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24DBS507; 50) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24DBC075; 51) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24CBG460; 52) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24ABO402; 53) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23LBU172; 54) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23KBK857; 55) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23KBJ794; 56) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23JBM608; 57) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23IBQ747; 58) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23IBO843; 59) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23IBO844; 60) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23HBT781; 61) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23FBK991; 62) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23FBC676; 63) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23EBG472; 64) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23CBW700; 65) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23CBM546
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A2660T; UDI: 04042761004183; All Lots.
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A22042A; UDI: 04042761020985; All Lots.
Mar 4, 2026
View details →Medline industries, lp
High PriorityActive
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
MDSALINE7 - UDI-DI: 10193489089356 (each), 20193489089353 (case), All Lots
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model No. A2642; UDI: 04042761004084; All Lots.
Mar 4, 2026
View details →Remel, inc
High PriorityActive
Campy CVA Medium 100/PK, R01272
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
UDI-DI 848838001055 Lot R01272 lot 339135 Expired January 12, 2026
Mar 4, 2026
View details →Encore medical, lp
High PriorityActive
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Knee and Humeral socket implants contain incorrect labeling.
Lot Code: Lot: 151T1055A GTIN: 00888912167147
Mar 4, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Model: A22014A (UDI: 04042761020893) and A22014T (UDI: 04042761020909). All lots.
Mar 4, 2026
View details →Fda
Low PriorityActive
Vasopressin Recall
Recalls and safety alerts
Mar 4, 2026
View details →Medline industries, lp
Low PriorityActive
Sterile Contro-Vac Whistle Tip Suction Cath W/2 Gl... Recall
Recalls and safety alerts
Feb 27, 2026
View details →Burlington medical inc.
Low PriorityActive
Burlington Medical Thyroid Shields Recall
Recalls and safety alerts
Feb 27, 2026
View details →Medtronic minimed
Low PriorityActive
Paradigm and MiniMed 600 and 700 series pumps Recall
Recalls and safety alerts
Feb 26, 2026
View details →Dmg chemisch-pharmazeutische fabrik gmbh
Low PriorityActive
Smartmix Tips Combi Recall
Recalls and safety alerts
Feb 26, 2026
View details →Product name
Low PriorityActive
Champignons et Adaptogènes: Affected lot contains ... Recall
Recalls and safety alerts
Feb 26, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0535PC; UDI: 04953170308659; All Lots.
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Lot Code: Model: TB-0520FC; UDI: 04953170370519, 04953170370502; All Lots.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21BMC737; 2) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21AMB799; 3) DYNJ56436B, UDI-DI: 10193489869569(each), 40193489869560(case), Lot Number: 21DME244; 4) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22IBU628; 5) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22GBV936; 6) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 25DME153; 7) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24KMA261; 8) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24JMA460; 9) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22NBG086; 10) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22BBD381
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0545IC; UDI: 04953170308673; All Lots.
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0535IC; UDI: 04953170464973; All Lots.
Feb 25, 2026
View details →Centinel spine, inc.
High PriorityActive
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Products were mislabeled as the 6mm product but included the 5 mm product.
Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0545FC; UDI: 04953170337543; All Lots.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC010543; 6) DRAWER 4, Model Number: ACC010722; 7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896; 8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U; 9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T; 10) CYSTO, Model Number: CDS981795G; 11) MAJOR PROCEDURE CDS, Model Number: CDS982414N; 12) TOTAL KNEE CDS, Model Number: CDS982823R; 13) VASCULAR CDS-1, Model Number: CDS982895I; 14) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069F; 15) HEART CABG CDS, Model Number: CDS983376S; 16) CRANIOTOMY, Model Number: CDS983611N; 17) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653K; 18) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653L; 19) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653M; 20) MAJOR ABDOMINAL CDS, Model Number: CDS983908Q; 21) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244I; 22) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431M; 23) MAJOR ABDOMINAL CDS (NO GOWNS), Model Number: CDS985557L; 24) PREP KIT, Model Number: DYK1022113CP; 25) BARRIER KIT,UNIV OF ALABAMA, Model Number: DYK1060193B; 26) PERSONAL ITEM KIT, Model Number: DYKA1131; 27) GI PACK, Model Number: DYKE1441D; 28) GI PACK, Model Number: DYKE1441G; 29) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456C; 30) VIDEO BRONCHOSCOPY TRAY, Model Number: DYKE1666; 31) GI LAB OTHER ENDO KIT, Model Number: DYKE1721A; 32) MATERNITY KIT, Model Number: DYKL1343; 33) BUNNY KIT, Model Number: DYKM1054C; 34) ASST STERILE PPE, Model Number: DYKM1270; 35) MASK CAP AND GOWN KIT, Model Number: DYKM1427A; 36) BLOOD PRECAUTION KIT, Model Number: DYKM1687; 37) HELPERS KIT, Model Number: DYKM1832; 38) BRONCHOSPY SUPPLY KIT, Model Number: DYKM1898; 39) OP UROLOGY KIT, Model Number: DYKM2316; 40) ICU PACK, Model Number: DYKM2671; 41) KIT OMF LEFORTE, Model Number: DYKMBNDL1; 42) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103; 43) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103A; 44) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103B; 45) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115; 46) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115A; 47) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115B; 48) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116C; 49) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117B; 50) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121D; 51) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121G; 52) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121I; 53) KIT ACES INSERT PEG, Model Number: DYKMBNDL130B; 54) KIT OMF PEDS MINOR, Model Number: DYKMBNDL139; 55) KIT THOR ESOPH PERF.REPAIR, Model Number: DYKMBNDL140; 56) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142A; 57) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146A; 58) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146C; 59) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146D; 60) KIT THORACIC THYMECTOMY, Model Number: DYKMBNDL161; 61) KIT ORTHO TOTAL SHOULDER, Model Number: DYKMBNDL162B; 62) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165B; 63) KIT OMF MINOR, Model Number: DYKMBNDL166; 64) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167; 65) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167A; 66) KIT TRANSPLANT LIVER EX-LAP, Model Number: DYKMBNDL167B; 67) KIT LAP DONOR NEPHRECTOMY, Model
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22HDA973; 2) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22BDB172; 3) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21LDA438; 4) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB692; 5) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB175; 6) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24GDA256; 7) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23IDB293; 8) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDC028; 9) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDB192; 10) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDA657; 11) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22LDA361; 12) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22KDB086; 13) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22JDB707; 14) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 21BDA319; 15) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 24DDA266; 16) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 23JDA838; 17) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 22FDB178; 18) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 22DDB648; 19) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 21KDA051; 20) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 25KDB023; 21) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 25JDB588; 22) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 23JDB732; 23) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 23CDB042; 24) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 22EDA459; 25) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 22CDA899; 26) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 21KDB787; 27) ACC010722, UDI-DI: 10195327472412(each), 40195327472413(case), Lot Number: 23JDC381; 28) ACC010722, UDI-DI: 10195327472412(each), 40195327472413(case), Lot Number: 23JDB244; 29) ACC010896, UDI-DI: 10198459166815(each), 40198459166816(case), Lot Number: 24LDA583; 30) CDS860063U, UDI-DI: 10195327148638(each), 40195327148639(case), Lot Number: 23LBO008; 31) CDS860066T, UDI-DI: 10195327107741(each), 40195327107742(case), Lot Number: 23LBK545; 32) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 24GBK408; 33) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 24BBL254; 34) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23JBS427; 35) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23EBW445; 36) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23EBH164; 37) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23CBG007; 38) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23ABD835; 39) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22KBV668; 40) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22JBH118; 41) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22HBM408; 42) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22DBF114; 43) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21LBE721; 44) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21IBP643; 45) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21FBT373; 46) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21DBC918; 47) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21BBE784; 48) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 22OBM444; 49) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 22GBH219; 50) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 22BBB915; 51) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21IBL978; 52) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21GBE905; 53) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21FBG328; 54) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21DBU729; 55) CDS982823R, UDI-DI: 10195327584481(each), 40195327584482(case), Lot Number: 24CBI679; 56) CDS982823R, UDI-DI: 10195327584481(each), 40195327584482(case), Lot Number: 24BBG787; 57) CDS982895I, UDI-DI: 10889942207688(each), 40889942207689(case), Lot Number: 21EBA011; 58) CDS983069F, UDI-DI: 10889942773558(each), 40889942773559(case), Lot Number: 21EBK915; 59) CDS983069F, UDI-DI: 10889942773558(each), 40889942773559(case), Lot Number: 21BBN554; 60) CDS983069F, UDI-DI: 10889942773558(each), 40889942773559(case), Lot Number: 20LBY313; 61) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24LMA929; 62) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24GMB750; 63) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24FMG753; 64) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24FMG397; 65) CDS983376S, UDI-DI: 10195327651886(each), 40195327651887(case), Lot Number: 24FMC832; 66) CDS983611N, UDI-DI: 10195327466626(each), 40195327466627(case), Lot Number: 24BBI517; 67) CDS983653K, UDI-DI: 10198459041136(each), 40198459041137(case), Lot Number: 24JBO747; 68) CDS983653K, UDI-DI: 10198459041136(each), 40198459041137(case), Lot Number: 24IBK669; 69) CDS983653K, UDI-DI: 10198459041136(each), 40198459041137(case), Lot Number: 24HBF890; 70) CDS983653K, UDI-DI: 10198459041136(each), 40198459041137(case), Lot Number: 24GBJ030; 71) CDS983653L, UDI-DI: 10198459235306(each), 40198459235307(case), Lot Number: 25EBM995; 72) CDS983653L, UDI-DI: 10198459235306(each), 40198459235307(case), Lot Number: 25DBF562; 73) CDS983653L, UDI-DI: 10198459235306(each), 40198459235307(case), Lot Number: 25CBF099; 74) CDS983653L, UDI-DI: 10198459235306(each), 40198459235307(case), Lot Number: 25ABT992; 75) CDS983653M, UDI-DI: 10198459413292(each), 40198459413293(case), Lot Number: 25HBB402; 76) CDS983908Q, UDI-DI: 10195327584450(each), 40195327584451(case), Lot Number: 24ABS333; 77) CDS984244I, UDI-DI: 10889942842148(each), 40889942842149(case), Lot Number: 21CBF877; 78) CDS985431M, UDI-DI: 10198459037801(each), 40198459037802(case), Lot Number: 24HBA354; 79) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 23BBG723; 80) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22HBS739; 81) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22HBJ007; 82) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22GBY286; 83) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22FBW150; 84) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 22DBJ805; 85) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 21JBZ371; 86) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 21IBC926; 87) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 21GBL281; 88) CDS985557L, UDI-DI: 10193489487350(each), 40193489487351(case), Lot Number: 21EBO754; 89) DYK1022113CP, UDI-DI: 10080196110773(each), 40080196110774(case), Lot Number: 25AMB800; 90) DYK1022113CP, UDI-DI: 10080196110773(each), 40080196110774(case), Lot Number: 23LMI081; 91) DYK1022113CP, UDI-DI: 10080196110773(each), 40080196110774(case), Lot Number: 20LMD225; 92) DYK1022113CP, UDI-DI: 10080196110773(each), 40080196110774(case), Lot Number: 20LMC553; 93) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 25CBC746; 94) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24KBP439; 95) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24JBA718; 96) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24GBG009; 97) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24EBJ092; 98) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24CBD288; 99) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 24ABO807; 100) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23LBH944; 101) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23KBI856; 102) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23HBQ265; 103) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23FBG126; 104) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23EBK977; 105) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23CBW954; 106) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 23BBA942; 107) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22LBK107; 108) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22JBQ642; 109) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22HBW429; 110) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22GBB583; 111) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22EBG095; 112) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22CBB236; 113) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22BBL267; 114) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 22ABB932; 115) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21KBG247; 116) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21JBM301; 117) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21IBT308; 118) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21CBP418; 119) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21BBN188; 120) DYK1060193B, UDI-DI: 10884389871744(each), 40884389871745(case), Lot Number: 21ABO769; 121) DYKA1131, UDI-DI: 10888277991262(each), 40888277991263(case), Lot Number: 22AFA117; 122) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 22JME976; 123) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 22HMA346; 124) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 22EMH722; 125) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 22DMA777; 126) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21KMI229; 127) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21IMH528; 128) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21HMC199; 129) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21GMD509; 130) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21FMC679; 131) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21EBO411; 132) DYKE1441D, UDI-DI: 10193489391879(each), 40193489391870(case), Lot Number: 21DBB848; 133) DYKE1441G, UDI-DI: 10198459003073(each), 40198459003074(case), Lot Number: 24FMI903; 134) DYKE1441G, UDI-DI: 10198459003073(each), 40198459003074(case), Lot Number: 24FME663; 135) DYKE1456C, UDI-DI: 10193489823226(each), 40193489823227(case), Lot Number: 23EBP851; 136) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 25GDB455; 137) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 25DDB861; 138) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 24HDB750; 139) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 24FDC135; 140) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 24EDA406; 141) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 24DDB221; 142) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 24CDA282; 143) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 24ADB503; 144) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 23JDA597; 145) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 23HDA426; 146) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 23FDA620; 147) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 23EDA004; 148) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 23DDA364; 149) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 22LDA865; 150) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 22JDA378; 151) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 22HDB410; 152) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 22EDB614; 153) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 22DDC322; 154) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 22DDB582; 155) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 21LDC130; 156) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 21JDC666; 157) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 21IDB553; 158) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 21HDB814; 159) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 21HDA031; 160) DYKE1666, UDI-DI: 10193489708486(each), 40193489708487(case), Lot Number: 21GDD269; 161) DYKE1721A, UDI-DI: 10195327538255(each), 40195327538256(case), Lot Number: 24IMA870; 162) DYKE1721A, UDI-DI: 10195327538255(each), 40195327538256(case), Lot Number: 24FMD146; 163) DYKE1721A, UDI-DI: 10195327538255(each), 40195327538256(case), Lot Number: 24DMJ263; 164) DYKE1721A, UDI-DI: 10195327538255(each), 40195327538256(case), Lot Number: 24CMD024; 165) DYKE1721A, UDI-DI: 10195327538255(each), 40195327538256(case), Lot Number: 23LMF047; 166) DYKE1721A, UDI-DI: 10195327538255(each), 40195327538256(case), Lot Number: 23LMB534; 167) DYKE1721A, UDI-DI: 10195327538255(each), 40195327538256(case), Lot Number: 23KMJ257; 168) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 23FBR252; 169) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 23EBL784; 170) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 23CBP403; 171) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 23BBD037; 172) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22KBS470; 173) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22JBM949; 174) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22IBT545; 175) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22HBU673; 176) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22FBM370; 177) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22FBD680; 178) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22EBE895; 179) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22CBM960; 180) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22ABU756; 181) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 22ABH226; 182) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 21KBP180; 183) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 21JBP035; 184) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 21HBS740; 185) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 21GBL919; 186) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 21FBK066; 187) DYKL1343, UDI-DI: 10193489509410(each), 40193489509411(case), Lot Number: 20LBT016; 188) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 23EMH031; 189) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 23DMH249; 190) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 23DMG480; 191) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 23BMD903; 192) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 23BMB049; 193) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 22LMF699; 194) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 22DME876; 195) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 22AME140; 196) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 21LMC439; 197) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 21IMA591; 198) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 21HMF079; 199) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 21GMF582; 200) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 21EMF240; 201) DYKM1054C, UDI-DI: 10889942151981(each), 40889942151982(case), Lot Number: 21EMA540; 202) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 24CBN118; 203) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 24BBK416; 204) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 24ABH744; 205) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 23KBX499; 206) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 23KBI021; 207) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 23JBQ242; 208) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 23IBS169; 209) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 23HBM172; 210) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 23EBS195; 211) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 23CBW456; 212) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 23BBN672; 213) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 22OBA972; 214) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 22LBD051; 215) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 22JBM926; 216) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 22EBN316; 217) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 21GBT888; 218) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 21GBT277; 219) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 21DBT927; 220) DYKM1270, UDI-DI: 10889942173396(each), 40889942173397(case), Lot Number: 21ABT306; 221) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 24DBL978; 222) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 24CBE349; 223) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 24BBA818; 224) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 23KBA304; 225) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 23HBZ677; 226) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 23GBI560; 227) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 23EBD426; 228) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 23CBH976; 229) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 23ABI630; 230) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 21LBQ538; 231) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 21LBQ537; 232) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 21JBZ167; 233) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 21JBH161; 234) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 21GBH732; 235) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 21DBT305; 236) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 21DBF736; 237) DYKM1427A, UDI-DI: 10193489609837(each), 40193489609838(case), Lot Number: 21ABR215; 238) DYKM1687, UDI-DI: 10193489546620(each), 40193489546621(case), Lot Number: 21FBJ727; 239) DYKM1687, UDI-DI: 10193489546620(each), 40193489546621(case), Lot Number: 21ABE572; 240) DYKM1832, UDI-DI: 10193489685688(each), 40193489685689(case), Lot Number: 25CBG784; 241) DYKM1832, UDI-DI: 10193489685688(each), 40193489685689(case), Lot Number: 24IBI292; 242) DYKM1832, UDI-DI: 10193489685688(each), 40193489685689(case), Lot Number: 23HBY061; 243) DYKM1832, UDI-DI: 10193489685688(each), 40193489685689(case), Lot Number: 23DBB608; 244) DYKM1898, UDI-DI: 10193489243055(each), 40193489243056(case), Lot Number: 22CDC318; 245) DYKM2316, UDI-DI: 10198459366239(each), 40198459366230(case), Lot Number: 25GBA774; 246) DYKM2671, UDI-DI: 10195327493714(each), 40195327493715(case), Lot Number: 24GBG843; 247) DYKM2671, UDI-DI: 10195327493714(each), 40195327493715(case), Lot Number: 24FBR906; 248) DYKM2671, UDI-DI: 10195327493714(each), 40195327493715(case), Lot Number: 24FBA084; 249) DYKM2671, UDI-DI: 10195327493714(each), 40195327493715(case), Lot Number: 24DBJ362; 250) DYKM2671, UDI-DI: 10195327493714(each), 40195327493715(case), Lot Number: 24BBO942; 251) DYKM2671, UDI-DI: 10195327493714(each), 40195327493715(case), Lot Number: 24ABO348; 252) DYKM2671, UDI-DI: 10195327493714(each), 40195327493715(case), Lot Number: 23KBH766; 253) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22HLA261; 254) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22GLA493; 255) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22FLA454; 256) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22FLA314; 257) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22ELA827; 258) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22ELA312; 259) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22DLA672; 260) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22DLA179; 261) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22CLA547; 262) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 22BLA359; 263) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21LLA482; 264) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21LLA185; 265) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21KLA409; 266) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21JLB155; 267) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21JLA894; 268) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21JLA341; 269) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21ILA504; 270) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21HLA962; 271) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21HLA437; 272) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21HLA177; 273) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21GLA290; 274) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21FLA587; 275) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21FLA213; 276) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21ELA731; 277) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21ELA428; 278) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21DLA249; 279) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21CLA204; 280) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21BBM417; 281) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21BBC461; 282) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 21ALA322; 283) DYKMBNDL1, UDI-DI: 10193489477320(each), 40193489477321(case), Lot Number: 20LLA561; 284) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 22HLA830; 285) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 22GLA310; 286) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 22ELA846; 287) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 22DLA932; 288) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 22DLA320; 289) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 22CLB344; 290) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 22ALA580; 291) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 21LLA929; 292) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 21ILA379; 293) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 21GLA217; 294) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 21DLA475; 295) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 21ALA013; 296) DYKMBNDL103, UDI-DI: 10193489478938(each), 40193489478939(case), Lot Number: 21ABL152; 297) DYKMBNDL103A, UDI-DI: 10195327240530(each), 40195327240531(case), Lot Number: 23JLA731; 298) DYKMBNDL103A, UDI-DI: 10195327240530(each), 40195327240531(case), Lot Number: 23HLB091; 299) DYKMBNDL103A, UDI-DI: 10195327240530(each), 40195327240531(case), Lot Number: 22KLA675; 300) DYKMBNDL103A, UDI-DI: 10195327240530(each), 40195327240531(case), Lot Number: 22KLA129; 301) DYKMBNDL103B, UDI-DI: 10195327633769(each), 40195327633760(case), Lot Number: 25HLA962; 302) DYKMBNDL103B, UDI-DI: 10195327633769(each), 40195327633760(case), Lot Number: 25FLA935; 303) DYKMBNDL103B, UDI-DI: 10195327633769(each), 40195327633760(case), Lot Number: 25FLA319; 304) DYKMBNDL103B, UDI-DI: 10195327633769(each), 40195327633760(case), Lot Number: 25CLB010; 305) DYKMBNDL103B, UDI-DI: 10195327633769(each), 40195327633760(case), Lot Number: 24BLA319; 306) DYKMBNDL103B, UDI-DI: 10195327633769(each), 40195327633760(case), Lot Number: 24BLA254; 307) DYKMBNDL115, UDI-DI: 10193489479324(each), 40193489479325(case), Lot Number: 21CBM523; 308) DYKMBNDL115, UDI-DI: 10193489479324(each), 40193489479325(case), Lot Number: 21BBG086; 309) DYKMBNDL115, UDI-DI: 10193489479324(each), 40193489479325(case), Lot Number: 21ABJ084; 310) DYKMBNDL115A, UDI-DI: 10193489880663(each), 40193489880664(case), Lot Number: 22ILA833; 311) DYKMBNDL115A, UDI-DI: 10193489880663(each), 40193489880664(case), Lot Number: 22FLA256; 312) DYKMBNDL115A, UDI-DI: 10193489880663(each), 40193489880664(case), Lot Number: 22ELA020; 313) DYKMBNDL115A, UDI-DI: 10193489880663(each), 40193489880664(case), Lot Number: 21KLA174; 314) DYKMBNDL115A, UDI-DI: 10193489880663(each), 40193489880664(case), Lot Number: 21HLB024; 315) DYKMBNDL115B, UDI-DI: 10195327240653(each), 40195327240654(case), Lot Number: 23BLA553; 316) DYKMBNDL115B, UDI-DI: 10195327240653(each), 40195327240654(case), Lot Number: 23BLA018; 317) DYKMBNDL115B, UDI-DI: 10195327240653(each), 40195327240654(case), Lot Number: 23ALA296; 318) DYKMBNDL116C, UDI-DI: 10195327374037(each), 40195327374038(case), Lot Number: 23LBL346; 319) DYKMBNDL116C, UDI-DI: 10195327374037(each), 40195327374038(case), Lot Number: 23JBP799; 320) DYKMBNDL116C, UDI-DI: 10195327374037(each), 40195327374038(case), Lot Number: 23IBV270; 321) DYKMBNDL116C, UDI-DI: 10195327374037(each), 40195327374038(case), Lot Number: 23IBK824; 322) DYKMBNDL116C, UDI-DI: 10195327374037(each), 40195327374038(case), Lot Number: 23IBI622; 323) DYKMBNDL116C, UDI-DI: 10195327374037(each), 40195327374038(case), Lot Number: 23EBI383; 324) DYKMBNDL117B, UDI-DI: 10195327241018(each), 40195327241019(case), Lot Number: 23BLB116; 325) DYKMBNDL117B, UDI-DI: 10195327241018(each), 40195327241019(case), Lot Number: 22LLA121; 326) DYKMBNDL117B, UDI-DI: 10195327241018(each), 40195327241019(case), Lot Number: 22JLA139; 327) DYKMBNDL121D, UDI-DI: 10195327608842(each), 40195327608843(case), Lot Number: 24CLA598; 328) DYKMBNDL121D, UDI-DI: 10195327608842(each), 40195327608843(case), Lot Number: 24ALA924; 329) DYKMBNDL121G, UDI-DI: 10198459085833(each), 40198459085834(case), Lot Number: 24KLA981; 330) DYKMBNDL121G, UDI-DI: 10198459085833(each), 40198459085834(case), Lot Number: 24KLA042; 331) DYKMBNDL121G, UDI-DI: 10198459085833(each), 40198459085834(case), Lot Number: 24JLA166; 332) DYKMBNDL121G, UDI-DI: 10198459085833(each), 40198459085834(case), Lot Number: 24HLA594; 333) DYKMBNDL121G, UDI-DI: 10198459085833(each), 40198459085834(case), Lot Number: 24HLA573; 334) DYKMBNDL121I, UDI-DI: 10198459250361(each), 40198459250362(case), Lot Number: 25GLA922; 335) DYKMBNDL121I, UDI-DI: 10198459250361(each), 40198459250362(case), Lot Number: 25GLA262; 336) DYKMBNDL121I, UDI-DI: 10198459250361(each), 40198459250362(case), Lot Number: 25FLA625; 337) DYKMBNDL121I, UDI-DI: 10198459250361(each), 40198459250362(case), Lot Number: 25ELA796; 338) DYKMBNDL121I, UDI-DI: 10198459250361(each), 40198459250362(case), Lot Number: 25DLA785; 339) DYKMBNDL121I, UDI-DI: 10198459250361(each), 40198459250362(case), Lot Number: 25BLA210; 340) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 25ALA373; 341) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24LLA836; 342) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24KLB043; 343) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24KLA547; 344) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24ILA801; 345) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24ILA267; 346) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24GLA597; 347) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24FLA162; 348) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24DLA231; 349) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24BLA065; 350) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24ALA338; 351) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 24ALA316; 352) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 23LLA366; 353) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 23JLA980; 354) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 23JLA732; 355) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 23HLB087; 356) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 23GLA926; 357) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 23FLA985; 358) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 23CLA706; 359) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 23CLA403; 360) DYKMBNDL130B, UDI-DI: 10195327240547(each), 40195327240548(case), Lot Number: 22LLA868; 361) DYKMBNDL130B, UDI-DI: 10195327240547(ea
Feb 25, 2026
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Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K; 13) TOTAL KNEE CDS, Model Number: CDS981454L; 14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K; 15) TOTAL KNEE, Model Number: CDS981505O; 16) TOTAL KNEE, Model Number: CDS981505P; 17) TOTAL KNEE, Model Number: CDS981505Q; 18) TOTAL KNEE, Model Number: CDS981505R; 19) OR LAMINECTOMY CDS, Model Number: CDS981858F; 20) LAMI FUSION, Model Number: CDS982035W; 21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O; 22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P; 23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S; 24) TOTAL HIP CDS, Model Number: CDS983036K; 25) TOTAL KNEE CDS, Model Number: CDS983042K; 26) LOWER EXTREMITY CDS, Model Number: CDS983049K; 27) ZALE SPINE CDS, Model Number: CDS983182G; 28) TOTAL KNEE CDS, Model Number: CDS983297M; 29) SITTING CERVICAL CDS, Model Number: CDS983480G; 30) SHOULDER CDS, Model Number: CDS983581K; 31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G; 32) TOTAL HIP CDS, Model Number: CDS983840I; 33) TOTAL JOINT CDS-LF, Model Number: CDS983863D; 34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C; 35) TOTAL JOINT, Model Number: CDS983903D; 36) GB TOTAL KNEE, Model Number: CDS984147K; 37) GB LOWER EXTREMITY, Model Number: CDS984156L; 38) LOWER EXTREMTIY, Model Number: CDS984254K; 39) LOWER EXTREMTIY, Model Number: CDS984254L; 40) LOWER EXTREMTIY, Model Number: CDS984254M; 41) LAMI MICRODISC-LF, Model Number: CDS984527I; 42) EXTREMITY CDS-LF, Model Number: CDS984607G; 43) EXTREMITY CDS-LF, Model Number: CDS984607I; 44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C; 45) TOTAL JOINT CDS, Model Number: CDS985202B; 46) TOTAL JOINT CDS, Model Number: CDS985202C; 47) TRAUMA-LF, Model Number: CDS985279K; 48) ARTHROSCOPY CDS, Model Number: CDS985316A; 49) EXTREMITY CDS, Model Number: CDS985317C; 50) EXTREMITY CDS, Model Number: CDS985317D; 51) EXTREMITY CDS, Model Number: CDS985317F; 52) EXTREMITY CDS, Model Number: CDS985317G; 53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J; 54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W; 55) JOINT ASPIRATION KIT, Model Number: DYKM1161; 56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106; 57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137; 58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A; 59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141; 60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A; 61) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141B; 62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C; 63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143; 64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144; 65
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS940087AG, UDI-DI: 10193489847260(each), 40193489847261(case), Lot Number: 21EBC900; 2) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22GBE442; 3) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBG548; 4) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBF695; 5) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBA274; 6) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22BBY060; 7) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21KBH163; 8) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21JBF936; 9) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21IBJ260; 10) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21GBI183; 11) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21FBS254; 12) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21BBL223; 13) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21LBO219; 14) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBQ650; 15) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBB625; 16) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBV695; 17) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBU197; 18) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21GBR895; 19) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23JBI054; 20) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23GBP400; 21) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23EBW653; 22) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23DBR887; 23) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23CBG614; 24) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBK758; 25) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBJ844; 26) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBK666; 27) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBI093; 28) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22JBH355; 29) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22HBS531; 30) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBM598; 31) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBL549; 32) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK859; 33) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK858; 34) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBL968; 35) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBC616; 36) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21KBF393; 37) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21JBO077; 38) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBV804; 39) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBB808; 40) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23EBK295; 41) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23CBT556; 42) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23BBP326; 43) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABH483; 44) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABG351; 45) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22IBE748; 46) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS173; 47) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS172; 48) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22FBD583; 49) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22DBN516; 50) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 21LBW480; 51) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21FBH003; 52) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21ABX303; 53) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22OBL581; 54) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22IMH323; 55) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22GBM603; 56) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22FBO257; 57) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22DBD515; 58) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21VBC540; 59) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21JBA989; 60) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21JBA988; 61) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21IBP619; 62) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23FMI799; 63) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23EME858; 64) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23DMF336; 65) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23DMB940; 66) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23CMA547; 67) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24IMH073; 68) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24HMH806; 69) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24FMG472; 70) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24EMC301; 71) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24CMC328; 72) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24AMG267; 73) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23KMH550; 74) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23IMA365; 75) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23HMF744; 76) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24DMH818; 77) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24CMC092; 78) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24BMF152; 79) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24AMB397; 80) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23FME101; 81) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23EMG643; 82) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23DMH779; 83) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23CMF017; 84) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23CMB403; 85) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 25BMJ035; 86) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 25AMJ535; 87) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24LMC844; 88) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24KMB678; 89) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24JMB660; 90) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24GMI703; 91) CDS981502K, UDI-DI: 10195327295370(each), 40195327295371(case), Lot Number: 24CMF795; 92) CDS981502K, UDI-DI: 10195327295370(each), 40195327295371(case), Lot Number: 23JMI916; 93) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22KBM385; 94) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22JBK515; 95) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22IBJ349; 96) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22HBQ624; 97) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22HBN671; 98) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22FBS293; 99) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22ABS105; 100) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 24BBH054; 101) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 24ABU182; 102) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23KBQ766; 103) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23KBQ737; 104) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23GBG193; 105) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23DBL133; 106) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23CBU775; 107) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23CBI326; 108) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23ABG957; 109) CDS981505Q, UDI-DI: 10198459028991(each), 40198459028992(case), Lot Number: 24IBD132; 110) CDS981505Q, UDI-DI: 10198459028991(each), 40198459028992(case), Lot Number: 24GBJ138; 111) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 25DBO814; 112) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 25BBD996; 113) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 24LBR473; 114) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 24KBP956; 115) CDS981858F, UDI-DI: 10889942973682(each), 40889942973683(case), Lot Number: 21ABH636; 116) CDS982035W, UDI-DI: 10193489999259(each), 40193489999250(case), Lot Number: 22HBP524; 117) CDS982035W, UDI-DI: 10193489999259(each), 40193489999250(case), Lot Number: 22GBI202; 118) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 23AMB059; 119) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 22LMB455; 120) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 22CME430; 121) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 25BMC093; 122) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24FMA426; 123) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24EMD974; 124) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24CMB637; 125) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24AMD955; 126) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 23IMF292; 127) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 23HME111; 128) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25LME952; 129) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25LMD470; 130) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25KMJ877; 131) CDS983036K, UDI-DI: 10193489842012(each), 40193489842013(case), Lot Number: 23KBN289; 132) CDS983042K, UDI-DI: 10193489842029(each), 40193489842020(case), Lot Number: 23KBN273; 133) CDS983049K, UDI-DI: 10193489841657(each), 40193489841658(case), Lot Number: 23JBY028; 134) CDS983049K, UDI-DI: 10193489841657(each), 40193489841658(case), Lot Number: 23JBX571; 135) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21JBY974; 136) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21JBD011; 137) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21HBK744; 138) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21DBH504; 139) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21CBT358; 140) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 20LBW136; 141) CDS983297M, UDI-DI: 10193489425857(each), 40193489425858(case), Lot Number: 21FDA407; 142) CDS983480G, UDI-DI: 10195327497842(each), 40195327497843(case), Lot Number: 24CDB716; 143) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 25BMI188; 144) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 24CMA539; 145) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 24AME511; 146) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 23IMA904; 147) CDS983838G, UDI-DI: 10193489600360(each), 40193489600361(case), Lot Number: 21ADB812; 148) CDS983840I, UDI-DI: 10193489405668(each), 40193489405669(case), Lot Number: 21FDA409; 149) CDS983863D, UDI-DI: 10889942570980(each), 40889942570981(case), Lot Number: 22KDB188; 150) CDS983863D, UDI-DI: 10889942570980(each), 40889942570981(case), Lot Number: 22JDB465; 151) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 23EBK642; 152) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 23ABM823; 153) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22LBO557; 154) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22KBS560; 155) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22HBT635; 156) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22EBV412; 157) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22ABS153; 158) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22ABP297; 159) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21JBK128; 160) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21IBA056; 161) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21DBU793; 162) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21CBF370; 163) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21CBC111; 164) CDS983903D, UDI-DI: 10198459053474(each), 40198459053475(case), Lot Number: 24HBQ596; 165) CDS984147K, UDI-DI: 10193489245424(each), 40193489245425(case), Lot Number: 21EBR750; 166) CDS984147K, UDI-DI: 10193489245424(each), 40193489245425(case), Lot Number: 21DBI790; 167) CDS984147K, UDI-DI: 10193489245424(each), 40193489245425(case), Lot Number: 21CBJ921; 168) CDS984156L, UDI-DI: 10193489245370(each), 40193489245371(case), Lot Number: 21DBQ627; 169) CDS984156L, UDI-DI: 10193489245370(each), 40193489245371(case), Lot Number: 21CBJ888; 170) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22KBP500; 171) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22HBP143; 172) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22GBO260; 173) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22EBJ581; 174) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22CBW600; 175) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22BBX356; 176) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21KBY807; 177) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21HBM083; 178) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21GBU901; 179) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21FBL924; 180) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21CBD679; 181) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23EBJ573; 182) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23DBD812; 183) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23CBR791; 184) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23BBS246; 185) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23ABK592; 186) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 25KBK734; 187) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 25IBW208; 188) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 25GBG607; 189) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24KBJ956; 190) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24IBP093; 191) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24IBB732; 192) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24GBU116; 193) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24GBB449; 194) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24EBF862; 195) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24DBS099; 196) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24BBS781; 197) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24ABT691; 198) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 23JBT902; 199) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 23HBV822; 200) CDS984527I, UDI-DI: 10193489376739(each), 40193489376730(case), Lot Number: 21BDA355; 201) CDS984607G, UDI-DI: 10889942719389(each), 40889942719380(case), Lot Number: 21EBC029; 202) CDS984607G, UDI-DI: 10889942719389(each), 40889942719380(case), Lot Number: 21ABV551; 203) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23DBK552; 204) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23BBU944; 205) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23ABE701; 206) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23ABA744; 207) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22JBQ863; 208) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22JBH295; 209) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22IBP797; 210) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22IBO809; 211) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22HBJ382; 212) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22GBF580; 213) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22EBS549; 214) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22EBR470; 215) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22EBQ393; 216) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22CBP419; 217) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21VBC530; 218) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21LBE361; 219) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21JBM719; 220) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21IBK997; 221) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 23BBG636; 222) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 23ABF816; 223) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22OBI284; 224) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22KBB895; 225) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22GBU468; 226) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22FBK619; 227) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22BBL459; 228) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 21LBQ977; 229) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 21IBV618; 230) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 24BBB251; 231) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23LBV047; 232) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23LBI902; 233) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23KBB103; 234) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23HBH071; 235) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23FBV622; 236) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23FBE479; 237) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23BBS726; 238) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 25BBD069; 239) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24LBI139; 240) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24JBU521; 241) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24JBM801; 242) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24EBR586; 243) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24DBD819; 244) CDS985279K, UDI-DI: 10195327497460(each), 40195327497461(case), Lot Number: 24CDA763; 245) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23GBT765; 246) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23DBD828; 247) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23CBP302; 248) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23ABC226; 249) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22NBE575; 250) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22LBT331; 251) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22JBR384; 252) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22GBU431; 253) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22FBQ646; 254) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22FBM692; 255) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22FBB121; 256) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21LBI665; 257) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21LBH556; 258) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21GBL257; 259) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21CBM829; 260) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21ABP208; 261) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24IBU020; 262) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24GBW059; 263) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24FBN572; 264) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24DBF304; 265) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24BBO443; 266) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24ABT609; 267) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 23JBS895; 268) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 23IBA494; 269) CDS985317D, UDI-DI: 10198459152450(each), 40198459152451(case), Lot Number: 25CBV211; 270) CDS985317D, UDI-DI: 10198459152450(each), 40198459152451(case), Lot Number: 25BBD080; 271) CDS985317D, UDI-DI: 10198459152450(each), 40198459152451(case), Lot Number: 24LBD251; 272) CDS985317F, UDI-DI: 10198459309311(each), 40198459309312(case), Lot Number: 25HBD051; 273) CDS985317F, UDI-DI: 10198459309311(each), 40198459309312(case), Lot Number: 25FBK413; 274) CDS985317G, UDI-DI: 10198459509063(each), 40198459509064(case), Lot Number: 25LBC622; 275) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 23ABE885; 276) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 22KBC308; 277) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 21CBU636; 278) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 21CBH306; 279) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25KDA137; 280) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25GDA910; 281) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25DDB938; 282) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25ADB448; 283) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 24IDA344; 284) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 24HDA224; 285) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 24ADA064; 286) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23JDB638; 287) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23CDB828; 288) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23BDB741; 289) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23ADB631; 290) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 22JDB343; 291) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 22FDB552; 292) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 22EDA009; 293) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 21HDC208; 294) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 21ADB694; 295) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 21ADA639; 296) DYKM1161, UDI-DI: 10888277838529(each), 40888277838520(case), Lot Number: 23ABS895; 297) DYKM2106, UDI-DI: 10195327020736(each), 40195327020737(case), Lot Number: 22FBT157; 298) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 25CBT503; 299) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24HBH168; 300) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24GBC828; 301) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24FBB726; 302) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24BBJ839; 303) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24ABH888; 304) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22KBO875; 305) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22JBP430; 306) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22IBS840; 307) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22FBI537; 308) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22FBF302; 309) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22DBM212; 310) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22CBB535; 311) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21HBG593; 312) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21HBF503; 313) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21EBE678; 314) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21ABM611; 315) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25GBP632; 316) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25FBU008; 317) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25FBK659; 318) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25EBK537; 319) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25BBI466; 320) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25ABS680; 321) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25ABQ126; 322) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24KBQ931; 323) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24IBE136; 324) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24GBV669; 325) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24GBH578; 326) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23LBO287; 327) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23KBV904; 328) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23JBB704; 329) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23HBY495; 330) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23HBH773; 331) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23GBJ242; 332) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23FBE416; 333) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23EBL742; 334) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23DBL148; 335) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23ABK726; 336) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 22JBG015; 337) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 22JBF639; 338) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22HBQ237; 339) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22FBS797; 340) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBS811; 341) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBQ939; 342) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBQ935; 343) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBF963; 344) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22CBV519; 345) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22BBR667; 346) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22ABL303; 347) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21VBB503; 348) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21IBK151; 349) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21IBJ315; 350) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21GBO489; 351) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21GBJ360; 352) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21FBF908; 353) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21EBM705; 354) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21CBJ601; 355) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21CBF326; 356) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21CBB270; 357) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21BBF813; 358) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21ABL153; 359) DYKMBNDL141A, UDI-DI: 1019532724776
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE KIT, Model Number: DYNDA2076C; 6) CARDIAC CATH PACK-LF, Model Number: DYNJ0150605AC; 7) CATH LAB PACK-LF, Model Number: DYNJ0648473Y; 8) NBMC CATH PACK-LF, Model Number: DYNJ0803367I; 9) ANGIO PACK-LF, Model Number: DYNJ0954970I; 10) CARDIAC CATH PACK, Model Number: DYNJ19946M; 11) CATH LAB PACK, Model Number: DYNJ30955I; 12) CATH LAB PACK, Model Number: DYNJ31773K; 13) CATH PACK-LF, Model Number: DYNJ33061D; 14) DB CCL OAKWOOD PACK-LF, Model Number: DYNJ33620D; 15) CARDIAC CATH PACK MRH-LF, Model Number: DYNJ35300M; 16) CATH LAB PK, Model Number: DYNJ35643C; 17) CARDIAC CATH PACK-LF, Model Number: DYNJ39066B; 18) CATH PACK-LF, Model Number: DYNJ43101C; 19) OR ANGIO PACK-LF, Model Number: DYNJ43415D; 20) OR ANGIO PACK-LF, Model Number: DYNJ43415F; 21) ANGIOPLASTY PACK, Model Number: DYNJ44700J; 22) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 23) RADIOLOGICAL PACK, Model Number: DYNJ44889O; 24) CARDIAC CATH PACK, Model Number: DYNJ47370B; 25) ANGIOGRAPHY PACK, Model Number: DYNJ53129D; 26) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ56772G; 27) DR. MOHINDRA PACK, Model Number: DYNJ57602G; 28) NE ENDO VASCULAR PACK, Model Number: DYNJ57940B; 29) CARDIAC CATH PACK - Q1, Model Number: DYNJ58048C; 30) OR ANGIO, Model Number: DYNJ59931B; 31) LPCH PERRY CATH PACK, Model Number: DYNJ67378C; 32) HOSPITAL REGIONAL DE CONCEPCIO, Model Number: DYNJ67918A; 33) CATH LAB PACK, Model Number: DYNJ68633; 34) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197B; 35) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197C; 36) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197D; 37) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197F; 38) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197G; 39) BASIC CARDIAC CATH PACK, Model Number: DYNJ81593B; 40) UMC EL PASO CATH PACK, Model Number: DYNJ83089; 41) DR. MOHINDRA PACK, Model Number: DYNJ83819A; 42) VZ VAS/ANG PACK, Model Number: DYNJ83981; 43) WCPN CARDIOLOGY PACK, Model Number: DYNJ84539; 44) CATH LAB, Model Number: DYNJ85511; 45) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJT1520K; 46) ANGIOGRAPHY TRAY, Model Number: MNS9130; 47) CVC BUNDLE KIT, Model Number: ECVC6225A; 48) CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS985094F, UDI-DI: 10195327657642(each), 40195327657643(case), Lot Number: 25AMG933; 2) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 22ABO093; 3) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21LBJ748; 4) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21BBG516; 5) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21ABI976; 6) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 22ALA279; 7) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21KLA100; 8) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA930; 9) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25ALA014; 10) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24FLA816; 11) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24CLA777; 12) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23KLA402; 13) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23JLA979; 14) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23ILA268; 15) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23HLA316; 16) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA710; 17) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA176; 18) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23BLA583; 19) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 22HLB260; 20) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24LMB205; 21) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24KMC111; 22) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24HMD928; 23) DYNJ0150605AC, UDI-DI: 10198459106422(each), 40198459106423(case), Lot Number: 24IMB736; 24) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25EBR586; 25) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25CBO084; 26) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25BBT175; 27) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25ABH209; 28) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24LBE715; 29) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24IBS786; 30) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24HBQ060; 31) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24GBT979; 32) DYNJ0803367I, UDI-DI: 10195327461027(each), 40195327461028(case), Lot Number: 23IMC122; 33) DYNJ0954970I, UDI-DI: 10198459297571(each), 40198459297572(case), Lot Number: 25FMJ515; 34) DYNJ19946M, UDI-DI: 10193489907933(each), 40193489907934(case), Lot Number: 23HBO857; 35) DYNJ30955I, UDI-DI: 10195327428051(each), 40195327428052(case), Lot Number: 23GBN513; 36) DYNJ31773K, UDI-DI: 10195327245856(each), 40195327245857(case), Lot Number: 23ABB938; 37) DYNJ33061D, UDI-DI: 10193489841428(each), 40193489841429(case), Lot Number: 21CBI315; 38) DYNJ33620D, UDI-DI: 10889942677832(each), 40889942677833(case), Lot Number: 21ADA464; 39) DYNJ35300M, UDI-DI: 10195327101169(each), 40195327101160(case), Lot Number: 22JMB302; 40) DYNJ35643C, UDI-DI: 10195327111946(each), 40195327111947(case), Lot Number: 23CBI301; 41) DYNJ39066B, UDI-DI: 10193489937268(each), 40193489937269(case), Lot Number: 23HMG433; 42) DYNJ43101C, UDI-DI: 10888277737327(each), 40888277737328(case), Lot Number: 21ADA535; 43) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24CBG256; 44) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24ABI910; 45) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 23IBP533; 46) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 25EBF775; 47) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24LBQ306; 48) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24KBR090; 49) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24IBU874; 50) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24HBM254; 51) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24GBV382; 52) DYNJ44700J, UDI-DI: 10195327277413(each), 40195327277414(case), Lot Number: 25JDA679; 53) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23IBB504; 54) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23GBP204; 55) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23FBF258; 56) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23EBG893; 57) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23DBI845; 58) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23BBD736; 59) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23ABR589; 60) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22OBA581; 61) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22LBG760; 62) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBY064; 63) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBC588; 64) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22IBT510; 65) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22HBM547; 66) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22FBN577; 67) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22EBP030; 68) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22CBV346; 69) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABK883; 70) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABI539; 71) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 21KBO116; 72) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22CMA383; 73) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22AME756; 74) DYNJ47370B, UDI-DI: 10889942975723(each), 40889942975724(case), Lot Number: 22LBP706; 75) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23HMH791; 76) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23GMI002; 77) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23FME772; 78) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23EME724; 79) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23DMF448; 80) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23CMB279; 81) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23BMC700; 82) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22LMD047; 83) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22KMC442; 84) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22JME805; 85) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22IMG735; 86) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22GMI134; 87) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22CMH914; 88) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22BMG182; 89) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22AMD580; 90) DYNJ57602G, UDI-DI: 10195327338169(each), 40195327338160(case), Lot Number: 23BBK044; 91) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 23KBB465; 92) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25KMD960; 93) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25JME465; 94) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25AMG240; 95) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24KMD474; 96) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24JMJ426; 97) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24HMF813; 98) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24GMH576; 99) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24EMH576; 100) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMG251; 101) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMC509; 102) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMG318; 103) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMF744; 104) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23LMD057; 105) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23KMH102; 106) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23IMD765; 107) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23GMF491; 108) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23FME284; 109) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23DMI350; 110) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23BME160; 111) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23AMI769; 112) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 22LMA967; 113) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23GBC772; 114) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23EBN753; 115) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23CBU118; 116) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23ABL095; 117) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22LBA917; 118) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22KBH299; 119) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22HBI355; 120) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22FBU003; 121) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBS611; 122) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBM388; 123) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22BBX590; 124) DYNJ67378C, UDI-DI: 10195327697501(each), 40195327697502(case), Lot Number: 24HME465; 125) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22OBG779; 126) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ027; 127) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ026; 128) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 21LBP804; 129) DYNJ68633, UDI-DI: 10193489837667(each), 40193489837668(case), Lot Number: 21BBQ520; 130) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23GBC445; 131) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23FBA862; 132) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBR165; 133) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBF780; 134) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23IBT017; 135) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23HBZ547; 136) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23GBJ036; 137) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24JBE696; 138) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24IBL386; 139) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24HBK118; 140) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24GBA095; 141) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24EBU925; 142) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24DBF346; 143) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24ABW070; 144) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25EBR556; 145) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25DBT193; 146) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25CBG703; 147) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 24LBU027; 148) DYNJ81197G, UDI-DI: 10198459369179(each), 40198459369170(case), Lot Number: 25FBT968; 149) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23IBJ841; 150) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23GBO156; 151) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23EBT723; 152) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23IMB693; 153) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23GMD133; 154) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23FMC409; 155) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23EMF492; 156) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMD375; 157) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMA913; 158) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23BMB766; 159) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 22JMI325; 160) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23HBX967; 161) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBV261; 162) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBJ743; 163) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23EBU525; 164) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23CBS129; 165) DYNJ83981, UDI-DI: 10195327324124(each), 40195327324125(case), Lot Number: 23CMI086; 166) DYNJ84539, UDI-DI: 10195327375706(each), 40195327375707(case), Lot Number: 23FMH066; 167) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 25EBR907; 168) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24LBK715; 169) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24KBR659; 170) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24IBI836
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJ35363A, UDI-DI: 10884389516461(each), 40884389516462(case), Lot Number: 21BBP020; 2) SPTPCD10005, UDI-DI: 10080196228652(each), 40080196228653(case), Lot Number: 24JBB041
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0535FCS; UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540; All Lots.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24DBT832; 2) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24CBH626; 3) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23LBR075; 4) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23FBF248; 5) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23CBG610
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21BBG085; 2) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21ABJ542; 3) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22CLA049; 4) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22BLB059; 5) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22ALA713; 6) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 21KLA631; 7) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21CBS043; 8) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS540; 9) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS539; 10) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21BBG092; 11) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21ABI996; 12) DYKMBNDL189A, UDI-DI: 10193489880823(each), 40193489880824(case), Lot Number: 21JLA521
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191; 2) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199; 3) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23KBM369; 4) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23JBU616; 5) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ759; 6) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ571; 7) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23GBA105; 8) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23CBO830; 9) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABM709; 10) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABE738; 11) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22OBM690; 12) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBW565; 13) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBL256; 14) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBJ798; 15) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBU353; 16) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBT770; 17) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22HBU935; 18) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22GBQ917; 19) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22EBK678; 20) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22CBC309; 21) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21LBV113; 22) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21KBW667; 23) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21IBG586; 24) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21GBH886; 25) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21EBN817; 26) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21CKA394; 27) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21ELA419; 28) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21DLA296; 29) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ELA870; 30) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24KLA701; 31) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21EBK732; 32) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21DBA306; 33) CDS840150T, UDI-DI: 10193489996197(each), 40193489996198(case), Lot Number: 21JBA896; 34) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22LBS336; 35) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22JBD465; 36) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22GBD762; 37) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22EBL398; 38) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22CBF996; 39) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22ABA269; 40) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 24ABJ652; 41) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC879; 42) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC675; 43) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23HBJ716; 44) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23EBB628; 45) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23DBN632; 46) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP521; 47) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP520; 48) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24EBK094; 49) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24DBB189; 50) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24CBQ331; 51) CDS840246O, UDI-DI: 10198459095955(each), 40198459095956(case), Lot Number: 25BLA225; 52) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25EBF565; 53) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25CBO300; 54) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABU765; 55) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABA041; 56) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24LBK995; 57) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24JBJ413; 58) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24IBM204; 59) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24GBQ632; 60) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24FBS248; 61) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBU862; 62) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBK620; 63) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24CBF421; 64) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 24ABB897; 65) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23LBK827; 66) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23JBM632; 67) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23GBJ781; 68) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBQ953; 69) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23FBF165; 70) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23DBE827; 71) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 23ABG192; 72) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22OBA486; 73) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22KBO918; 74) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22IBE745; 75) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBX514; 76) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 22FBL409; 77) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25HBM750; 78) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25FBD477; 79) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25JBQ605; 80) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25IBD204; 81) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 82) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 83) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 84) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBQ865; 85) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23GBN891; 86) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23BBG436; 87) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABG179; 88) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 23ABF773; 89) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG079; 90) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG077; 91) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22JBG072; 92) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF451; 93) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22FBF439; 94) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22DBL431; 95) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE659; 96) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 22ABE658; 97) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21KBQ156; 98) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21IBO083; 99) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21HBO916; 100) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 21CBG242; 101) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBK781; 102) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBD493; 103) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBP788; 104) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 105) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 106) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 107) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 108) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBJ654; 109) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 110) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 111) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21GBS209; 112) CDS840428K, UDI-DI: 10884389911235(each), 40884389911236(case), Lot Number: 21BBH224; 113) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25DBQ683; 114) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25CBI244; 115) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBM940; 116) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 25BBF438; 117) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24JBS428; 118) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24HBL828; 119) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24GBU141; 120) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24EBC679; 121) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24CBB817; 122) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 24ABX492; 123) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBU791; 124) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23EBA214; 125) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 23CBR891; 126) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22KBW189; 127) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22IBV957; 128) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22HBA238; 129) CDS840428L, UDI-DI: 10193489922660(each), 40193489922661(case), Lot Number: 22GLA269; 130) CDS980839C, UDI-DI: 10193489723076(each), 40193489723077(case), Lot Number: 21FBB093; 131) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25CMJ833; 132) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 25BMD423; 133) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24JMF683; 134) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24HMA337; 135) CDS982564C, UDI-DI: 10193489873177(each), 40193489873178(case), Lot Number: 24EMG641; 136) CDS982566K, UDI-DI: 10193489435597(each), 40193489435598(case), Lot Number: 21CBQ731; 137) CDS982575K, UDI-DI: 10193489734799(each), 40193489734790(case), Lot Number: 21BKA040; 138) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBS146; 139) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21JBQ075; 140) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBQ086; 141) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21HBF470; 142) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21GBK054; 143) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21EKA064; 144) CDS982575M, UDI-DI: 10193489845754(each), 40193489845755(case), Lot Number: 21DKA457; 145) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22LBS833; 146) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22JBP075; 147) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22IBU776; 148) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22GBM066; 149) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22FBF335; 150) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22EBL281; 151) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22DBI104; 152) CDS982575O, UDI-DI: 10195327101237(each), 40195327101238(case), Lot Number: 22BBQ149; 153) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 24BBB783; 154) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23LBS018; 155) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23KBK940; 156) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23IBP737; 157) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBT093; 158) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23HBF574; 159) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBU058; 160) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23FBL415; 161) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBT572; 162) CDS982575P, UDI-DI: 10195327348908(each), 40195327348909(case), Lot Number: 23CBL429; 163) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21FBF717; 164) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21EBC025; 165) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21DBP216; 166) CDS983348S, UDI-DI: 10193489458992(each), 40193489458993(case), Lot Number: 21CBK379; 167) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23IBR206; 168) CDS983376Q, UDI-DI: 10195327379797(each), 40195327379798(case), Lot Number: 23FBU833; 169) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DMH143; 170) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25DME288; 171) CDS983376T, UDI-DI: 10198459197338(each), 40198459197339(case), Lot Number: 25CME797; 172) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25HMA016; 173) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GMG706; 174) CDS983376U, UDI-DI: 10198459397585(each), 40198459397586(case), Lot Number: 25GME704; 175) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMH340; 176) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25LMF022; 177) CDS983376V, UDI-DI: 10198459475337(each), 40198459475338(case), Lot Number: 25IMH581; 178) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 23BBE439; 179) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22KBI289; 180) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22IBD426; 181) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 22HBI664; 182) CDS983513F, UDI-DI: 10193489843729(each), 40193489843720(case), Lot Number: 21FBF442; 183) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24CME689; 184) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 24AMD733; 185) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23KMC560; 186) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23HMC461; 187) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMH171; 188) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23GMG766; 189) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23FMI141; 190) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23EMF372; 191) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 23DMH027; 192) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22KMH072; 193) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22JMB563; 194) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMF199; 195) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22HMB738; 196) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22FMC683; 197) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 22CMB854; 198) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21LMA822; 199) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21KMA019; 200) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21JMB643; 201) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21IMH924; 202) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21GMC871; 203) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21FMD794; 204) CDS983786D, UDI-DI: 10193489590197(each), 40193489590198(case), Lot Number: 21AKA832; 205) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMF693; 206) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24JMC120; 207) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMG956; 208) CDS983786F, UDI-DI: 10195327684594(each), 40195327684595(case), Lot Number: 24IMB935; 209) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25KMI896; 210) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25JME849; 211) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 25BMD134; 212) CDS983786G, UDI-DI: 10198459166822(each), 40198459166823(case), Lot Number: 24LMC522; 213) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23BBJ754; 214) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 23ABA881; 215) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22OBL943; 216) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22JBU821; 217) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 22EBM615; 218) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMH819; 219) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21KMC359; 220) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21IMC057; 221) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GME785; 222) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21GBA694; 223) CDS984117F, UDI-DI: 10193489520408(each), 40193489520409(case), Lot Number: 21BKA482; 224) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24LMC474; 225) CDS984276P, UDI-DI: 10195327446802(each), 40195327446803(case), Lot Number: 24KMC946; 226) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21KLB205; 227) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21ILA628; 228) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21HLA680; 229) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLB087; 230) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA312; 231) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21GLA057; 232) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21FLA954; 233) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21EKA147; 234) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21DKA676; 235) CDS984289J, UDI-DI: 10193489263046(each), 40193489263047(case), Lot Number: 21BKA389; 236) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBV540; 237) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23FBP065; 238) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 23ABP719; 239) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22OBI364; 240) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22LBQ630; 241) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22JBT625; 242) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22IBT454; 243) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22HBL442; 244) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22FBX071; 245) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22EBL445; 246) CDS984289K, UDI-DI: 10195327067243(each), 40195327067244(case), Lot Number: 22ABF746; 247) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24EBT292; 248) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24DBU415; 249) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBO822; 250) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24CBL931; 251) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23LBB141; 252) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23KBA264; 253) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 23JBB129; 254) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24LBA755; 255) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBN423; 256) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBA684; 257) CDS984289N, UDI-DI: 10198459256769(each), 40198459256760(case), Lot Number: 25FBD048; 258) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBL186; 259) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBC732; 260) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBB599; 261) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25GBY100; 262) CDS984355F, UDI-DI: 10888277770348(each), 40888277770349(case), Lot Number: 20LKB341; 263) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23LLA067; 264) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23JLA617; 265) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23ILB099; 266) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23HLA237; 267) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA762; 268) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 23CLA569; 269) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA693; 270) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22LLA544; 271) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22JLB146; 272) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILB092; 273) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22ILA721; 274) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22FLA187; 275) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 22BLA378; 276) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA543; 277) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21HLA499; 278) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21GLA223; 279) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21FLA649; 280) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21EKA150; 281) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA538; 282) CDS984355G, UDI-DI: 10193489484632(each), 40193489484633(case), Lot Number: 21DKA352; 283) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24ELA326; 284) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24BLA231; 285) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 24LLA698; 286) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21FBE255; 287) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21BBS510; 288) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21ABE734; 289) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21LBP381; 290) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21JBZ656; 291) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21IBO615; 292) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21HBD158; 293) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23JBT159; 294) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23HBP383; 295) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23FBV374; 296) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23EBS635; 297) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23DBR889; 298) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23ABT277; 299) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22LBD272; 300) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBP078; 301) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBD236; 302) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBT102; 303) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBE901; 304) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22GBU933; 305) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22DBS062; 306) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22BBS888; 307) CDS985215C, UDI-DI: 10193489780109(each), 40193489780100(case), Lot Number: 21DBH711; 308) CVT159AA, UDI-DI: 10193489457513(each), 40193489457514(case), Lot Number: 22DBL279; 309) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24FBJ229; 310) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24DBF439; 311) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24BBT324; 312) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23JBP216; 313) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23IBI960; 314) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23GBI903; 315) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23EBO066; 316) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23DBT226; 317) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22LBD173; 318) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22KBA324; 319) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22IBA742; 320) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22GBL773; 321) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22EBS701; 322) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBI986; 323) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBF497; 324) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21KBI013; 325) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21IBQ531; 326) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21HBC943; 327) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21FBO379; 328) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW789; 329) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW788; 330) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBV599; 331) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBK912; 332) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21HBL002; 333) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBO480; 334) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBJ355; 335) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBO542; 336) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBF909; 337) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBN048; 338) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBC538; 339) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBA605; 340) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBS016; 341) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBO740; 342) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBM813; 343) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBF850; 344) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21BBN597; 345) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABO823; 346) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABI967; 347) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22HLA262; 348) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLB050; 349) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLA352; 350) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELB070; 351) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELA030; 352) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22DLA405; 353) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22CLA548; 354) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22BLB034; 355) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA723; 356) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA370; 357) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21KLA410; 358) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21HLB002; 359) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21GLA991; 360) DYKMBNDL
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414; 6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R; 7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG; 8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416; 9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417; 10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418; 11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419; 12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462; 13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491; 14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492; 15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498; 16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003; 17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG; 18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008; 19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG; 20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009; 21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101; 22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A; 23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG; 24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103; 25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109; 26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002; 27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003; 28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106; 29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119; 30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215; 31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002; 32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006; 33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001; 34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003; 35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002; 36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG; 37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003; 38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG; 39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005; 40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG; 41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201; 42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG; 43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211; 44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301; 45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A; 46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG; 47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412; 48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG; 49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414; 50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001; 51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103; 52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901; 53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902; 54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30525050127; 2) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30525070161; 3) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30525070250; 4) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30525060147; 5) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522030151; 6) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522070033; 7) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522080015; 8) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522080067; 9) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522090028; 10) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522100060; 11) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522100091; 12) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522120121; 13) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522120207; 14) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30523010081; 15) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525030122; 16) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525050190; 17) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525040163; 18) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525060157; 19) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525080250; 20) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523010024; 21) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523010087; 22) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523020008; 23) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523030039; 24) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523110089; 25) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523120129; 26) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524020157; 27) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524020226; 28) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524030047; 29) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524040134; 30) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524050261; 31) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524060216; 32) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524080030; 33) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524100145; 34) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524120085; 35) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525050185; 36) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525070162; 37) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525070251; 38) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525060148; 39) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525080246; 40) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30522060085; 41) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 72524020098; 42) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 72524030048; 43) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 72524030074; 44) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 72524040022; 45) DYNJP2412T, UDI-DI: 10080196764877(each), 40080196764878(case), Lot Number: 30525030119; 46) DYNJP2412T, UDI-DI: 10080196764877(each), 40080196764878(case), Lot Number: 30525050188; 47) DYNJP2412T, UDI-DI: 10080196764877(each), 40080196764878(case), Lot Number: 30525040156; 48) DYNJP2412T, UDI-DI: 10080196764877(each), 40080196764878(case), Lot Number: 30525080249; 49) DYNJP2412T, UDI-DI: 10080196764877(each), 40080196764878(case), Lot Number: 30522050063; 50) DYNJP2412T, UDI-DI: 10080196764877(each), 40080196764878(case), Lot Number: 30525010171; 51) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30525050125; 52) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30525050126; 53) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30525070159; 54) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30525070160; 55) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30525070249; 56) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30525060014; 57) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30525060223; 58) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30525080163; 59) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30525080245; 60) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522030028; 61) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522030150; 62) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522040022; 63) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522050012; 64) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522060005; 65) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522070034; 66) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522080013; 67) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522080065; 68) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522090024; 69) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522100001; 70) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522100059; 71) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522100090; 72) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522100100; 73) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522110055; 74) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522110059; 75) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522120106; 76) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30522120173; 77) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523010091; 78) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523010092; 79) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523020003; 80) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523020012; 81) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523020017; 82) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523030023; 83) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523030024; 84) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523040091; 85) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523040094; 86) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30523050063; 87) DYNJP2414, UDI-DI: 10080196739714(each), 40080196739715(case), Lot Number: 30524060253; 88) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30525050204; 89) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30525100372; 90) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30525020070; 91) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30525040195; 92) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30525060171; 93) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30525080300; 94) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30525090273; 95) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30525090296; 96) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30523060090; 97) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30523060168; 98) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30523070147; 99) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30523090105; 100) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30523100030; 101) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30523100137; 102) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30523110074; 103) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30523120118; 104) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524010124; 105) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524020105; 106) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524030028; 107) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524040128; 108) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524050012; 109) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524050264; 110) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524060217; 111) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524080015; 112) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524090010; 113) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524100144; 114) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524110015; 115) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30524120194; 116) DYNJP2414R, UDI-DI: 10080196764860(each), 40080196764861(case), Lot Number: 30525010206; 117) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72525020024; 118) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72525020064; 119) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72525020071; 120) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72525060016; 121) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72519120040; 122) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72520060132; 123) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72520080005; 124) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521030017; 125) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521040141; 126) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521050059; 127) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521050081; 128) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521050166; 129) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521080016; 130) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521090049; 131) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521110008; 132) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521110034; 133) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521120008; 134) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72521120027; 135) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522010033; 136) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522020008; 137) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522020055; 138) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522030019; 139) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522030039; 140) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522040008; 141) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522050011; 142) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522050017; 143) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522110039; 144) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522120005; 145) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72522120042; 146) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523010008; 147) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523020001; 148) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523020044; 149) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523030006; 150) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523060035; 151) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523080006; 152) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523080040; 153) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523090007; 154) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523100016; 155) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523100086; 156) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523110010; 157) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72523120075; 158) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524010038; 159) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524020042; 160) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524020099; 161) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524030049; 162) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524030075; 163) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524040065; 164) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524050016; 165) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524060062; 166) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524070048; 167) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524080027; 168) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524090025; 169) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524100025; 170) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72524120024; 171) DYNJP2414UG, UDI-DI: 10884389815649(each), 40884389815640(case), Lot Number: 72525010015; 172) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525030213; 173) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525050171; 174) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525050172; 175) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525070154; 176) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525070178; 177) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525070225; 178) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525070281; 179) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525020080; 180) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525040216; 181) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525060022; 182) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525060197; 183) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525080307; 184) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525090066; 185) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30524110004; 186) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30524110005; 187) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30524120002; 188) DYNJP2416, UDI-DI: 10080196739738(each), 40080196739739(case), Lot Number: 30525010230; 189) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30525050186; 190) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30525020053; 191) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30525040149; 192) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30525060149; 193) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30522080035; 194) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30522090018; 195) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30522120214; 196) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523010096; 197) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523020002; 198) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523030030; 199) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523030040; 200) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523050015; 201) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523060172; 202) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523070149; 203) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523080102; 204) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523090099; 205) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523100008; 206) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523100097; 207) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523110068; 208) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30523120117; 209) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524010117; 210) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524020152; 211) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524020237; 212) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524030052; 213) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524040137; 214) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524050038; 215) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524050260; 216) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524060215; 217) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524080036; 218) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524090145; 219) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524100070; 220) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524100184; 221) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524110028; 222) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30524120082; 223) DYNJP2417, UDI-DI: 10080196739721(each), 40080196739722(case), Lot Number: 30525010169; 224) DYNJP2418, UDI-DI: 10080196740833(each), 40080196740834(case), Lot Number: 30522090005; 225) DYNJP2418, UDI-DI: 10080196740833(each), 40080196740834(case), Lot Number: 30522120134; 226) DYNJP2418, UDI-DI: 10080196740833(each), 40080196740834(case), Lot Number: 30522120217; 227) DYNJP2418, UDI-DI: 10080196740833(each), 40080196740834(case), Lot Number: 30523010089; 228) DYNJP2418, UDI-DI: 10080196740833(each), 40080196740834(case), Lot Number: 30523040093; 229) DYNJP2418, UDI-DI: 10080196740833(each), 40080196740834(case), Lot Number: 30523050061; 230) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30525050105; 231) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30525070148; 232) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30525070197; 233) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30525070260; 234) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30525060012; 235) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30525060127; 236) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30525080158; 237) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30525080243; 238) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30525090038; 239) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30523050156; 240) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30523080099; 241) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30523110065; 242) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30523120135; 243) DYNJP2419, UDI-DI: 10080196900107(each), 40080196900108(case), Lot Number: 30524010125; 244) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30525030124; 245) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30525070168; 246) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30525020064; 247) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30525040179; 248) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30525060163; 249) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30523050021; 250) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30523060167; 251) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30523080146; 252) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30523100028; 253) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30523100136; 254) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30523110063; 255) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30523120120; 256) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524010126; 257) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524020147; 258) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524030039; 259) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524040131; 260) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524050023; 261) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524060027; 262) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524070074; 263) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524080021; 264) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524100177; 265) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524110020; 266) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30524120093; 267) DYNJP2462, UDI-DI: 10080196763054(each), 40080196763055(case), Lot Number: 30525010189; 268) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30522090071; 269) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30522100064; 270) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30522100094; 271) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30522110057; 272) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30522120085; 273) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30522120128; 274) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30522120210; 275) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30523010100; 276) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30523030035; 277) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30523050009; 278) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30523050067; 279) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30523080101; 280) DYNJP2491, UDI-DI: 10080196283873(each), 40080196283874(case), Lot Number: 30523120179; 281) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525050180; 282) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525070149; 283) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525070198; 284) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525070261; 285) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525020038; 286) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525040126; 287) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525060128; 288) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525080159; 289) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525090039; 290) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522030152; 291) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522040019; 292) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522040027; 293) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522050011; 294) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522060007; 295) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522070040; 296) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522080011; 297) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522080062; 298) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522090027; 299) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522100089; 300) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522110056; 301) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522120084; 302) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522120131; 303) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30522120180; 304) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523010099; 305) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523020013; 306) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523030029; 307) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523050012; 308) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523050060; 309) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523070088; 310) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523080136; 311) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523090020; 312) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523090098; 313) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523090101; 314) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523100006; 315) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523100101; 316) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523110075; 317) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523110081; 318) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523110184; 319) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30523120132; 320) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30524010005; 321) DYNJP2492, UDI-DI: 10080196736522(each), 40080196736523(case), Lot Number: 30525010035; 322) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30525050121; 323) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30525020049; 324) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522030153; 325) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522040001; 326) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522040002; 327) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522040025; 328) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522050010; 329) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522060003; 330) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522070041; 331) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522080010; 332) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522080061; 333) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522090020; 334) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522100065; 335) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522100088; 336) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522110053; 337) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522110058; 338) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522120082; 339) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522120124; 340) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30522120174; 341) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523010082; 342) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523020010; 343) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523020014; 344) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523020015; 345) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523030025; 346) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523030033; 347) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523050002; 348) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523050057; 349) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523070084; 350) DYNJP2498, UDI-DI: 10080196739493(each), 40080196739494(case), Lot Number: 30523080100; 351) DYNJP249
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 11) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 12) C-SECTION PACK, Model Number: DYNJ23544F; 13) C-SECTION PACK, Model Number: DYNJ32632F; 14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 15) C-SECTION PACK-LF, Model Number: DYNJ38801F; 16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 17) C-SECTION, Model Number: DYNJ41444F; 18) C-SECTION PACK, Model Number: DYNJ49224I; 19) C SECTION PACK-LF, Model Number: DYNJ52387I; 20) C-SECTION PACK, Model Number: DYNJ56523C; 21) C-SECTION PACK, Model Number: DYNJ59387L; 22) C-SECTION PACK, Model Number: DYNJ64549B; 23) C SECTION PACK, Model Number: DYNJ67347A; 24) C SECTION PACK, Model Number: DYNJ69778A; 25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 27) PAD C-SECTION, Model Number: DYNJ902134C; 28) RICH C-SECTION, Model Number: DYNJ902182J; 29) C-SECTION PACK, Model Number: DYNJ904329D; 30) C-SECTION, Model Number: DYNJ904697F; 31) KIT C SECTION, Model Number: DYNJ906966G; 32) C SECTION, Model Number: DYNJ907999A; 33) C-SECTION, Model Number: DYNJ909058; 34) C-SECTION PACK, Model Number: DYNJ909507; 35) C SECTION TRAY, Model Number: DYNJT3407; 36) TR-C SECTION PACK-LF, Model Number: PHS583549002B
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS820080N, UDI-DI: 10195327278014(each), 40195327278015(case), Lot Number: 23IMB818; 2) CDS983523G, UDI-DI: 10195327283681(each), 40195327283682(case), Lot Number: 23IBS984; 3) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21WBA953; 4) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21LBC555; 5) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21CBN328; 6) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22IBG757; 7) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU298; 8) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU297; 9) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU296; 10) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22EBA155; 11) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBT090; 12) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBH774; 13) DYNJ0101616I, UDI-DI: 10193489248814(each), 40193489248815(case), Lot Number: 21ADA105; 14) DYNJ15494G, UDI-DI: 10193489961195(each), 40193489961196(case), Lot Number: 22LBS122; 15) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24GMF054; 16) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24FMB372; 17) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMB123; 18) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMD085; 19) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23LME909; 20) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 25BMB041; 21) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24LMH886; 22) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24KMD458; 23) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25IMA090; 24) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25FMI427; 25) DYNJ19529S, UDI-DI: 10198459566257(each), 40198459566258(case), Lot Number: 25KMA045; 26) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBL994; 27) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBJ153; 28) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21BBM422; 29) DYNJ23544F, UDI-DI: 10889942533053(each), 40889942533054(case), Lot Number: 23IMA860; 30) DYNJ32632F, UDI-DI: 10193489888966(each), 40193489888967(case), Lot Number: 22HMC526; 31) DYNJ35100I, UDI-DI: 10195327097608(each), 40195327097609(case), Lot Number: 23IME105; 32) DYNJ38801F, UDI-DI: 10195327113117(each), 40195327113118(case), Lot Number: 23IBK585; 33) DYNJ40129C, UDI-DI: 10193489441772(each), 40193489441773(case), Lot Number: 23AMJ303; 34) DYNJ41444F, UDI-DI: 10193489740974(each), 40193489740975(case), Lot Number: 22JMB590; 35) DYNJ49224I, UDI-DI: 10193489371352(each), 40193489371353(case), Lot Number: 21DDA358; 36) DYNJ52387I, UDI-DI: 10193489248272(each), 40193489248273(case), Lot Number: 21ADA540; 37) DYNJ56523C, UDI-DI: 10193489430264(each), 40193489430265(case), Lot Number: 21ABS513; 38) DYNJ59387L, UDI-DI: 10195327159856(each), 40195327159857(case), Lot Number: 23CBK420; 39) DYNJ64549B, UDI-DI: 10193489940725(each), 40193489940726(case), Lot Number: 23ABL355; 40) DYNJ67347A, UDI-DI: 10195327046156(each), 40195327046157(case), Lot Number: 22JMF954; 41) DYNJ69778A, UDI-DI: 10195327334420(each), 40195327334421(case), Lot Number: 23CBU899; 42) DYNJ900602I, UDI-DI: 10193489487121(each), 40193489487122(case), Lot Number: 20LDB302; 43) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25JDA979; 44) DYNJ902134C, UDI-DI: 10193489452280(each), 40193489452281(case), Lot Number: 21DBP451; 45) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 23ABM580; 46) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22OBJ456; 47) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22JBO865; 48) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22IBI254; 49) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22HBF417; 50) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22GBH232; 51) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22EBG610; 52) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22DBN664; 53) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22ABY311; 54) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBX738; 55) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBJ172; 56) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21IBL808; 57) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21GBB842; 58) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBS046; 59) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBQ743; 60) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21BBF750; 61) DYNJ904329D, UDI-DI: 10198459221071(each), 40198459221072(case), Lot Number: 25EBJ650; 62) DYNJ904697F, UDI-DI: 10195327169275(each), 40195327169276(case), Lot Number: 22FDA703; 63) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBS185; 64) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBF270; 65) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBV882; 66) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBR695; 67) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24DBN053; 68) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24BBV274; 69) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 22CMH174; 70) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21LMB616; 71) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21JMC590; 72) DYNJ909058, UDI-DI: 10195327259327(each), 40195327259328(case), Lot Number: 23EBP308; 73) DYNJ909507, UDI-DI: 10195327387075(each), 40195327387076(case), Lot Number: 23GME519; 74) DYNJT3407, UDI-DI: 10198459324970(each), 40198459324971(case), Lot Number: 25EBK673; 75) PHS583549002B, UDI-DI: 10193489643558(each), 40193489643559(case), Lot Number: 21ADA554
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) PAIN0150C, UDI-DI: 10193489819571(each), 21JBV886(case), Lot Number: 21JBV886
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 12) LAVH PACK, Model Number: DYNJ36712F; 13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 17) LAVH - N #668629 -N, Model Number: DYNJ58121C; 18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 20) D AND C PACK, Model Number: DYNJ61282B; 21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 22) PERI GYN, Model Number: DYNJ67708A; 23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 25) ANORECTAL PACK, Model Number: DYNJ83560; 26) D&C CDS, Model Number: DYNJ902560I; 27) HYSTEROSCOPY, Model Number: DYNJ903327K; 28) ROBOTIC HYST, Model Number: DYNJ903798G; 29) TLH KIT, Model Number: DYNJ908149; 30) LAVH TOTE, Model Number: DYNJ908340; 31) LAVH TOTE, Model Number: DYNJ908340A; 32) LAVH TOTE, Model Number: DYNJ908340B; 33) LAVH TOTE, Model Number: DYNJ908340D; 34) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 35) VAG HYST PACK, Model Number: DYNJT3348; 36) LAVH PART B, Model Number: DYNJV0312G
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24CBQ563; 2) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24ABO363; 3) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23IBV204; 4) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23HBY878; 5) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23GBE705; 6) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23HBI773; 7) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBD256; 8) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBC116; 9) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBS135; 10) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBL440; 11) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH451; 12) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH032; 13) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH028; 14) DYNJ0373807J, UDI-DI: 10193489942996(each), 40193489942997(case), Lot Number: 22EBC904; 15) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22JBO175; 16) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22HBV873; 17) DYNJ27434R, UDI-DI: 10195327107727(each), 40195327107728(case), Lot Number: 23EBQ683; 18) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21LBL067; 19) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21CBJ513; 20) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21ABP592; 21) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 23CMG183; 22) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22KMC218; 23) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22CBV220; 24) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23EMG111; 25) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23BMG588; 26) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 22LME145; 27) DYNJ33393M, UDI-DI: 10195327567323(each), 40195327567324(case), Lot Number: 24AMC141; 28) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24LME743; 29) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24HMH344; 30) DYNJ33393O, UDI-DI: 10198459244537(each), 40198459244538(case), Lot Number: 25CMI389; 31) DYNJ36712F, UDI-DI: 10195327148027(each), 40195327148028(case), Lot Number: 22KBH638; 32) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23HBF942; 33) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23GBF010; 34) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23FBJ953; 35) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23DBD471; 36) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23BBC494; 37) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22GBK309; 38) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22EBK097; 39) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22BBZ962; 40) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22ABL203; 41) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 21LBI132; 42) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25LBE575; 43) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25DBK709; 44) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25ABN265; 45) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24JBI039; 46) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24GBV369; 47) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24FBC228; 48) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23JBH886; 49) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23IBV025; 50) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23HBR561; 51) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23FBO439; 52) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23EBL258; 53) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23DBQ854; 54) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22HBB055; 55) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22GBG579; 56) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22ABU361; 57) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21KBQ945; 58) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21HBS940; 59) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21DBN261; 60) DYNJ47694I, UDI-DI: 10195327437046(each), 40195327437047(case), Lot Number: 24GMI287; 61) DYNJ51741B, UDI-DI: 10193489538939(each), 40193489538930(case), Lot Number: 22BBC761; 62) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23GMH701; 63) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23EMA454; 64) DYNJ59037B, UDI-DI: 10193489948196(each), 40193489948197(case), Lot Number: 22GBI562; 65) DYNJ59444G, UDI-DI: 10193489431650(each), 40193489431651(case), Lot Number: 20LMF707; 66) DYNJ61282B, UDI-DI: 10195327054663(each), 40195327054664(case), Lot Number: 24ABY154; 67) DYNJ67161, UDI-DI: 10193489396744(each), 40193489396745(case), Lot Number: 22CBY767; 68) DYNJ67708A, UDI-DI: 10195327039899(each), 40195327039890(case), Lot Number: 23JBW724; 69) DYNJ69713B, UDI-DI: 10195327340513(each), 40195327340514(case), Lot Number: 23JBY129; 70) DYNJ69713C, UDI-DI: 10195327594633(each), 40195327594634(case), Lot Number: 24EBR875; 71) DYNJ83560, UDI-DI: 10195327280291(each), 40195327280292(case), Lot Number: 23BBB410; 72) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 23AMI329; 73) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22JMF106; 74) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMC843; 75) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMB138; 76) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22HBB969; 77) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22ABL216; 78) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBH136; 79) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBC695; 80) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV717; 81) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV715; 82) DYNJ903798G, UDI-DI: 10193489420036(each), 40193489420037(case), Lot Number: 23ABR411; 83) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23EBV901; 84) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23BBM781; 85) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK510; 86) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK509; 87) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23CBD846; 88) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23ABR402; 89) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22HBS469; 90) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22BBV448; 91) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23JBI674; 92) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23IBF567; 93) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBT696; 94) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBE358; 95) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23EBR451; 96) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBV876; 97) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBG247; 98) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 23LBF494; 99) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 25ABM341; 100) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24JBK180; 101) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBM046; 102) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBG486; 103) DYNJ910537, UDI-DI: 10198459029936(each), 40198459029937(case), Lot Number: 24GBX676; 104) DYNJT3348, UDI-DI: 10198459323751(each), 40198459323752(case), Lot Number: 25EBN202; 105) DYNJV0312G, UDI-DI: 10198459489051(each), 40198459489052(case), Lot Number: 25LME070
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24EMC989; 2) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059A; 3) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059; 4) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24BBH600; 5) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23JBH393; 6) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23GBA134; 7) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBV199; 8) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBT510; 9) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBN951; 10) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23BBS986; 11) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23ABA768; 12) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 22JBH446
Feb 25, 2026
View details →Intuitive surgical, inc.
High PriorityActive
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Issue with software algorithm which may lead to overpressure events.
Model Number: UHI; UDI-DI: N/A; All Serial Numbers
Feb 25, 2026
View details →Integra lifesciences corp. (neurosciences)
High PriorityActive
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
Potential packaging failures, which could lead to a breach in the sterile barrier.
(1) Model Number: 31012; UDI-DI: 10381780486909; Lot numbers: A24008, A24057, B21123, B24075, C22159, C23177, C24148, D24190, E21365, E24254, E24255, G23393, H21523, H22452, H23443, I22512, I23464, J21693, L22706. (2) Model Number: 31022; UDI-DI: 10381780486916; Lot numbers: A23045, A23065, A25028, A25056, B23079, B25068, B25077, C21151, C21152, C21155, C21195, C22182, C22196, C23183, C23193, C25152, D23196, D23208, E21300, E22305, E22319, F21407, F21428, F21430, F22333, F24317, G23405, H21544, H22438, H23415, H23442, H23446, H24415, I21610, I21617, J22530 , J23551, J23560, J24622, K21723, K21739, K24625, K24646, L21838. (3) Model Number: 31045; UDI-DI: 10381780486923; Lot numbers: A21056, A22036, A22047, A24036, B21062, B21084, B21100, B21107, B21119, B25110, D21229, D21247, D22251, D22270, D22275, D23236, D23248, D24192, D24220, E21314, E21337, E21361, E22277, E23253, E23271, E24296, F21376, F22361, F22362, F22382, F23369, F23370, G21490, G21504, G22385, G23384, H21506, H21512, H21530, H23450, H23451, I22479, I22481, I22495, I23466, I23498, I24511, I24523, J21680, J21691, K21777, K21801, K21806, K22597, K22609, K22632, K22663, K24650, K24679, L21812, L21823, L22674, L22711, L23649.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525030011; 2) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525050004; 3) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100025; 4) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100068; 5) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525020012; 6) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525040038; 7) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060015; 8) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060041; 9) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080004; 10) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080039; 11) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120082; 12) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120084; 13) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120097; 14) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520020055; 15) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030039; 16) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030064; 17) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030074; 18) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520050047; 19) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060018; 20) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060019; 21) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520070016; 22) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080003; 23) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080004; 24) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080059; 25) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520100068; 26) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120003; 27) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120004; 28) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521040001; 29) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050060; 30) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050064; 31) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050167; 32) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521060070; 33) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070019; 34) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070099; 35) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521080017; 36) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090001; 37) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090015; 38) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100005; 39) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100033; 40) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110009; 41) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110016; 42) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120009; 43) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120031; 44) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522010013; 45) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522020010; 46) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522030020; 47) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522040019; 48) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050012; 49) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050015; 50) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060019; 51) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060052; 52) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522070003; 53) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522080008; 54) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522110004; 55) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522110040; 56) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522120006; 57) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523100020; 58) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523100063; 59) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523110004; 60) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523120076; 61) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524010036; 62) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524010087; 63) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524030056; 64) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524040002; 65) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524050034; 66) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524060001; 67) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524060034; 68) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524060098; 69) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524070001; 70) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524080004; 71) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524090003; 72) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524090078; 73) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524100004; 74) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524100099; 75) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524110013; 76) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524120003; 77) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525010001; 78) DYNJP8401, UDI-DI: 10080196740710(each), 40080196740711(case), Lot Number: 72521080034
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBL738; 2) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBJ847; 3) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBF936; 4) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBE795; 5) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22FBP788; 6) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22BBD031; 7) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22ABJ831; 8) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 21JBJ732; 9) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21CBZ902; 10) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21ABK153; 11) DYNJ32715F, UDI-DI: 10889942530038(each), 40889942530039(case), Lot Number: 21ADB529; 12) DYNJ50834C, UDI-DI: 10889942568178(each), 40889942568179(case), Lot Number: 21BDA710; 13) DYNJ51069, UDI-DI: 10889942118410(each), 40889942118411(case), Lot Number: 21BDB116
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) MINOR EYE PACK, Model Number: DYNJ17219C; 12) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 13) EYE PACK, Model Number: DYNJ41207C; 14) OPHTHALMIC PACK, Model Number: DYNJ42043I; 15) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 16) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 17) EYE PLASTIC PACK, Model Number: DYNJ47859B; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) CATARACT PACK, Model Number: DYNJ53019A; 20) CATARACT PACK, Model Number: DYNJ54869A; 21) VITRECTOMY PACK, Model Number: DYNJ55280B; 22) NDNW-EYE PACK, Model Number: DYNJ61779C; 23) EYE PK, Model Number: DYNJ62306; 24) VITRECTOMY, Model Number: DYNJ64220; 25) OSC BREAST PACK, Model Number: DYNJ65808C; 26) MILLS CATARACT PACK, Model Number: DYNJ67973A; 27) EYE PACK, Model Number: DYNJ68367B; 28) CATARACT PACK, Model Number: DYNJ68875D; 29) CATARACT PACK, Model Number: DYNJ68875F; 30) CATARACT PACK, Model Number: DYNJ68875G; 31) OPHTHO PLASTIC, Model Number: DYNJ902256C; 32) RETINAL, Model Number: DYNJ907495; 33) CATARACT, Model Number: DYNJ909924; 34) COMBO EYE, Model Number: DYNJ909925; 35) VITRECTOMY, Model Number: DYNJ909929
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 22GBP895; 2) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21IBV636; 3) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21FBP706; 4) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21ABV400; 5) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 24EBU650; 6) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 23HBV380; 7) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22KBO773; 8) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS907; 9) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS899; 10) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22HBX475; 11) DYKMBNDL159, UDI-DI: 10193489478273(each), 40193489478274(case), Lot Number: 21ABQ655; 12) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21FBP773; 13) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21BBM375; 14) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21ABT655; 15) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21KLA277; 16) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ILA655; 17) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21HLA179; 18) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21FLA394; 19) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21BBK655; 20) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ABR620; 21) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23DBD264; 22) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23CBP086; 23) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24HBS367; 24) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24EBF870; 25) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24CBA180; 26) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24BBJ841; 27) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24ABH891; 28) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23LBI221; 29) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23KBJ008; 30) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23JBK353; 31) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23IBA614; 32) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23GBE628; 33) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23FBU438; 34) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23EBL613; 35) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23CBP088; 36) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21GBJ364; 37) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21DBC009; 38) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21ABT657; 39) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22OBC233; 40) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22GBW969; 41) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22FBB999; 42) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW535; 43) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW517; 44) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 21IBP918; 45) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25EBG033; 46) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBU487; 47) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBJ362; 48) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 24FBB728; 49) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBD243; 50) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBA356; 51) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBT177; 52) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBC619; 53) DYNJ17219C, UDI-DI: 10888277053007(each), 40888277053008(case), Lot Number: 21ADA445; 54) DYNJ38791M, UDI-DI: 10193489665437(each), 40193489665438(case), Lot Number: 23EBS726; 55) DYNJ41207C, UDI-DI: 10195327353063(each), 40195327353064(case), Lot Number: 23KMH083; 56) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21HMC573; 57) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21GMA744; 58) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21DMA925; 59) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21CMA770; 60) DYNJ42043I, UDI-DI: 10193489389340(each), 40193489389341(case), Lot Number: 21BMA716; 61) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 22BMD451; 62) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 22AMC045; 63) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21JMF395; 64) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21IMH317; 65) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21HMB926; 66) DYNJ44852J, UDI-DI: 10193489859812(each), 40193489859813(case), Lot Number: 21GMD097; 67) DYNJ45585C, UDI-DI: 10195327475512(each), 40195327475513(case), Lot Number: 23IBE143; 68) DYNJ47859B, UDI-DI: 10889942899739(each), 40889942899730(case), Lot Number: 21DBQ717; 69) DYNJ47859B, UDI-DI: 10889942899739(each), 40889942899730(case), Lot Number: 21CBJ926; 70) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25FBE320; 71) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 25ABK875; 72) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24KBA576; 73) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24FBI469; 74) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24EBT972; 75) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24ABB652; 76) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23KBB813; 77) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23GBD486; 78) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23EBE835; 79) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23EBA347; 80) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 23CBC335; 81) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22JBS972; 82) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22EBT342; 83) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 22ABJ996; 84) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 21JBG678; 85) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 21FBM463; 86) DYNJ53019A, UDI-DI: 10889942582761(each), 40889942582762(case), Lot Number: 21ADA466; 87) DYNJ54869A, UDI-DI: 10889942606085(each), 40889942606086(case), Lot Number: 20XBF509; 88) DYNJ55280B, UDI-DI: 10193489919806(each), 40193489919807(case), Lot Number: 21GDB817; 89) DYNJ61779C, UDI-DI: 10195327379643(each), 40195327379644(case), Lot Number: 23EBQ641; 90) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22EBO615; 91) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22DBS613; 92) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 22ABU477; 93) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21KBM947; 94) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21JBD854; 95) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21GBG219; 96) DYNJ62306, UDI-DI: 10193489641943(each), 40193489641944(case), Lot Number: 21FBJ619; 97) DYNJ64220, UDI-DI: 10193489794618(each), 40193489794619(case), Lot Number: 21ABW916; 98) DYNJ65808C, UDI-DI: 10195327369064(each), 40195327369065(case), Lot Number: 23KMB340; 99) DYNJ67973A, UDI-DI: 10193489437386(each), 40193489437387(case), Lot Number: 22JBK486; 100) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23LMG710; 101) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23JMF562; 102) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23GMB569; 103) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23FMI783; 104) DYNJ68367B, UDI-DI: 10195327276935(each), 40195327276936(case), Lot Number: 23CMA209; 105) DYNJ68875D, UDI-DI: 10195327335076(each), 40195327335077(case), Lot Number: 23BBP426; 106) DYNJ68875F, UDI-DI: 10195327382124(each), 40195327382125(case), Lot Number: 23FBQ273; 107) DYNJ68875G, UDI-DI: 10195327537098(each), 40195327537099(case), Lot Number: 23LBK778; 108) DYNJ902256C, UDI-DI: 10195327089368(each), 40195327089369(case), Lot Number: 22FDA445; 109) DYNJ907495, UDI-DI: 10193489462135(each), 40193489462136(case), Lot Number: 22KDB104; 110) DYNJ907495, UDI-DI: 10193489462135(each), 40193489462136(case), Lot Number: 21CDB771; 111) DYNJ909924, UDI-DI: 10195327506728(each), 40195327506729(case), Lot Number: 23LBJ479; 112) DYNJ909925, UDI-DI: 10195327506735(each), 40195327506736(case), Lot Number: 23LBJ480; 113) DYNJ909929, UDI-DI: 10195327506759(each), 40195327506750(case), Lot Number: 23LBJ481
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number: CVI3650; 6) LINE ATTIRE KIT, Model Number: DYKM2170; 7) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153C; 8) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43A; 9) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43C; 10) VEIN PROCEDURE KIT, Model Number: DYNDA2076B; 11) VEIN PROCEDURE KIT, Model Number: DYNDA2076D; 12) VEIN PROCEDURE KIT, Model Number: DYNDA2076F; 13) PLACENTA KIT, Model Number: DYNDA2322B; 14) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407A; 15) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407B; 16) PICC LINE TRAY, Model Number: DYNJ40500A; 17) VENOUS ACCESS PACK, Model Number: DYNJ42694C; 18) AV FISTULA CREATION PACK-LF, Model Number: DYNJ53427B; 19) PICC LINE, Model Number: DYNJ55546D; 20) PICC TRAY, Model Number: DYNJ63199A; 21) PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB; 22) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 23) VEIN PACK, Model Number: DYNJ84239; 24) PICC INSERTION TRAY W/O CATH, Model Number: PICCNC0004
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) 00-401993O, UDI-DI: 10195327517366(each), 40195327517367(case), Lot Number: 23KBH528; 2) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188; 3) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23IDA297; 4) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23GDB567; 5) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23FDC048; 6) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDB175; 7) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDA455; 8) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23BDB271; 9) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22FDB218; 10) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22DDA763; 11) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22CDC433; 12) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22BDA862; 13) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22ADC105; 14) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21JDB458; 15) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21IDC222; 16) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21CDB078; 17) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21BDB379; 18) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24KDA478; 19) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24JDB298; 20) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24IDB060; 21) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24HDB961; 22) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23HDA348; 23) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB680; 24) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB672; 25) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDA369; 26) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23FDB587; 27) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23EDB085; 28) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 22BDB354; 29) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21LDB744; 30) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21CDC422; 31) CVI3650, UDI-DI: 10653160256397(each), 40653160256398(case), Lot Number: 22EBO541; 32) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23BBA792; 33) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23ABC583; 34) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 22IBN124; 35) DYKMBNDL153C, UDI-DI: 10198459000430(each), 40198459000431(case), Lot Number: 24DBR907; 36) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23BBS866; 37) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23ABK335; 38) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBM493; 39) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBK412; 40) DYKMBNDL43C, UDI-DI: 10198459000553(each), 40198459000554(case), Lot Number: 24DBS686; 41) DYNDA2076B, UDI-DI: 10195327572020(each), 40195327572021(case), Lot Number: 24ABI534; 42) DYNDA2076D, UDI-DI: 10198459216060(each), 40198459216061(case), Lot Number: 24LMH364; 43) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25KMH542; 44) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25IMA505; 45) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25HMH651; 46) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25FMF582; 47) DYNDA2322B, UDI-DI: 10195327299774(each), 40195327299775(case), Lot Number: 23FBW064; 48) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 22FME865; 49) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21OBA058; 50) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21LBT037; 51) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21JBV496; 52) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21DBA072; 53) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21ABI600; 54) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25IMA418; 55) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25FMG170; 56) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25EMA699; 57) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24IMD214; 58) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24DMF048; 59) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24CMI922; 60) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24AMB024; 61) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 23HMC992; 62) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23HBB480; 63) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23FBG757; 64) DYNJ42694C, UDI-DI: 10195327514334(each), 40195327514335(case), Lot Number: 24ABW686; 65) DYNJ53427B, UDI-DI: 10193489248227(each), 40193489248228(case), Lot Number: 20LDC151; 66) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23GBK664; 67) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23CBT475; 68) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23BBB100; 69) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22LBG357; 70) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22IBQ424; 71) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22JBN171; 72) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22IBO930; 73) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22BBP290; 74) DYNJ70141MB, UDI-DI: 10889942722808(each), 40889942722809(case), Lot Number: 21ADA546; 75) DYNJ70152MB, UDI-DI: 10889942722822(each), 40889942722823(case), Lot Number: 21ADA547; 76) DYNJ84239, UDI-DI: 10195327345624(each), 40195327345625(case), Lot Number: 23FBJ937; 77) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMD502; 78) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMA136; 79) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMI718; 80) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMG079; 81) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23EMF082; 82) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23BMF790; 83) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22LME863; 84) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22EBG055; 85) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22CBY021
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 6) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 7) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 8) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 9) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 10) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 11) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 12) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 16) CVC PACK, Model Number: CVI4500A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024100790; 2) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2025013190; 3) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024071790; 4) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024072390; 5) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024080190; 6) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024101490; 7) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2025010890; 8) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2025011090; 9) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2025012890; 10) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2025020690; 11) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2024012590; 12) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024030690; 13) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024041790; 14) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024052290; 15) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024053190; 16) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024060590; 17) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024061890; 18) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024062890; 19) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024071990; 20) DYKM1781A, UDI-DI: 10653160352730(each), 00653160352733(case), Lot Number: 2024092390; 21) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024093090; 22) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2024091290; 23) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024012490; 24) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024022190; 25) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023120590; 26) DYKM1751A, UDI-DI: 10193489111002(each), 20193489111009(case), Lot Number: 2023121190; 27) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023121490; 28) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2024031590; 29) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2024010880; 30) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023070590; 31) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023071290; 32) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023111590; 33) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2023120890; 34) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024011790; 35) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024062890; 36) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2024040180; 37) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023072590; 38) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023080190; 39) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023081490; 40) DYKM1767B, UDI-DI: 10193489112368(each), 20193489112365(case), Lot Number: 2023102790; 41) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2023101680; 42) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2023063090; 43) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2023112780; 44) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023050490; 45) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023060290; 46) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024032990; 47) CVI4500A, UDI-DI: 10653160327646(each), 00653160327649(case), Lot Number: 2020121550
Feb 25, 2026
View details →Medica corporation
High PriorityActive
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.
Feb 25, 2026
View details →Stryker corporation
High PriorityActive
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Catalog Number: MM1000 (Pack of 10) UDI (GTIN): 00850024195028 Serial Numbers: 23-0350 24-0118 24-0289 24-0290 24-0291 24-0472 24-0473 24-0474 24-0534 24-0535 24-0536 24-0658 24-0660 24-0697 25-0020 25-0021 25-0022 25-0160 25-0161 25-0162 25-0353 25-0354 25-1057 25-1058 25-1060 25-1087 23-0003 23-0046 23-0057 23-0062 23-0125 23-0126 23-0129 23-0176 23-0177 23-0179 23-0413 23-0414 24-0413 Catalog Number: MS-00009 (Pack of 10) UDI (GTIN):00850024195134 Serial Numbers: 22-0130 23-0022 23-0130 23-0178 24-0035 24-0117 24-0225 24-0235 24-0236 24-0659 24-0696 24-0719 25-0251 25-0252 Catalog Number: MP2001 UDI (GTIN): 00850024195141 Serial Numbers: 16 18 29 30 32 43 49 54 60 62 66 77 80 81 84 85 92 93 100 101 114 115 138 155 158 160 163 164 174 180 181 182 184 186 190 199 202 203 216 217 218 220 221 222 225 226 227 228 229 230 231 232 234 235 236 237 238 239 240 241 242 243 244 245 246 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 273 274 275 276 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542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 558 559 560 561 562 563 564 565 566 567 568 569 570 571 573 574 575 576 577 578 580 581 583 584 585 586 587 588 589 590 592 601 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 644 645 646 647 651 652 653 654 655 656 657 658 659 660 661 662 663 666 670 674 675 730 742 743 745 747 750 751 752 753 754 755 756 757 758 763 764 765 766 767 768 769 772 773 775 776 777 780 782 783 784 785 786 787 788 929 930 940 959 973 976 981 982 984 986 988 990 995 997 998 1001 1003 1004 1005 1006 1008 1009 1014 1015 1016 1092 Catalog Number: MP2015A UDI (GTIN): 00850024195219 Serial Numbers: 0010 0023 0030 0031 0032 0033 0034 0035 0036 0038 0039 0041 0042 0043 0044 0045 0046 0049 0050 0052 0054 0055 0056 0057 0059 0063 0065 0066 0070 0073 0074 0075 0076 0078 0079 0080 0081 0082 0085 0086 0087 0088 0089 0090 0091 0092 0094 0095 0096 0097 0099 0100 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0348 0349 0350 0353 0355 0357 0359 0361 0362 0363 0364 0366 0368 0369 0371 0372 0373 0375 0376 0377 0379 0381 0382 0383 0384 0385 0386 0388 0389 0390 0391 0392 0393 0394 0395 0396 0397 0398 0399 0400 0401 0402 0403 0404 0405 0406 0407 0408 0409 0410 0411 0412 0413 0414 0415 0416 0417 0418 0419 0420 0421 0422 0423 0424 0425 0426 0427 0428 0429 0430 0431 0432 0433 0434 0435 0436 0437 0438 0439 0441 0443 0444 0445 0446 0449 0453 0454 0459 0466 0482 0508 0509 0510 0511 0512 0513 0514 0515 0516 0517 0518 0520 0521 0522 0523 0525 0527 0530 0531 0532 0533 0534 0535 0536 0537 0538 0539 0540 0541 0543 0544 0545 0548 0549 0550 0551 0553 0554 0555 0557 0558 0560 0563 0566 0568 0569 0570 0571 0572 0573 0575 0576 0578 0579 0602 0603 0604 0605 0606 0607 0608 0609 0610 0611 0612 0613 Catalog Number: MT2001 UDI (GTIN): 00850024195158 Serial Numbers: 3 33 34 35 36 198 202 208 210 214 215 227 228 239 240 245 246 247 247 253 263 264 268 269 270 274 277 299 302 303 304 305 306 307 308 308 309 310 311 312 313 313 314 315 316 317 318 319 320 321 322 323 403 404 505 600 602 604 606 610 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646 647 648 649 650 652 653 654 654 655 656 657 659 660 661 662 663 1000 1001 1002 1003 1004 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1014 1015 1016 1017 1018 1019 1020 1021 1022 1023 1024 1025 1026 1028 1029 1030 1031 1032 1033 1034 1035 1036 1037 1039 1040 2013 2031 2032 2033 2034 2035 2036 2039 2200 2203 2204 2205 2208 2209 2210 2211 2211 2212 2213 2215 2216 2217 2218 2220 2221 2222 2224 2400 2401 2402 2403 2404 2405 2406 2407 2408 2409 2410 2411 2412 2413 2414 2415 2416 2416 2417 2418 2419 2420 2421 2422 2423 2423 2424 2425 2426 2427 2428 2429 2430 2431 2432 2433 2435 2436 2437 2438 2439 2440 2441 2442 2443 2444 2445 2446 2447 2449 2450 2451 2452 2453 3000 3001 3002 3002 3003 3005 3006 3007 3008 3009 3010 3011 3012 3013 3014 3015 3016 3017 3019 3020 3021 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Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066A; 6) SOUTH CATH LAB PACK, Model Number: DYNJ61978A; 7) BIOPSY ANGIO TRAY ALEX, Model Number: DYNJ63542B; 8) SURGICAL TECH KIT, Model Number: DYNJ907452; 9) ANGIOGRAPHY PACK, Model Number: DYNJC2371G; 10) SPECTRUM HEALTH CATH PACK-LF, Model Number: PHS853965G
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23KBQ544; 2) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23JBO193; 3) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21EBQ851; 4) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21DBA951; 5) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21BKA527; 6) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21AKB217; 7) DYNJ0842873J, UDI-DI: 10193489448917(each), 40193489448918(case), Lot Number: 21ADA204; 8) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBI127; 9) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBF322; 10) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22CBF108; 11) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22CLA012; 12) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22BLA508; 13) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21KLA332; 14) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21HLA812; 15) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21CLA325; 16) DYNJ61978A, UDI-DI: 10193489729306(each), 40193489729307(case), Lot Number: 20LDB953; 17) DYNJ63542B, UDI-DI: 10193489398632(each), 40193489398633(case), Lot Number: 23DBP359; 18) DYNJ907452, UDI-DI: 10193489422887(each), 40193489422888(case), Lot Number: 20LBW791; 19) DYNJC2371G, UDI-DI: 10889942494675(each), 40889942494676(case), Lot Number: 23BBT999; 20) PHS853965G, UDI-DI: 10193489249460(each), 40193489249461(case), Lot Number: 21ADA067
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 15) NEURO PACK, Model Number: DYNJ49098I; 16) NEURO PACK, Model Number: DYNJ53089B; 17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 20) NEURO PACK, Model Number: DYNJ60792B; 21) NEURO PACK, Model Number: DYNJ60792C; 22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 25) NEURO PACK, Model Number: DYNJ61740D; 26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 28) DISCECTOMY PACK, Model Number: DYNJ67835; 29) WWD NEURO PACK, Model Number: DYNJ80849B; 30) WWD NEURO PACK, Model Number: DYNJ80849J; 31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 32) NEURO, Model Number: DYNJ900904J; 33) NEURO, Model Number: DYNJ900904K; 34) NEURO, Model Number: DYNJ900904L; 35) NEURO, Model Number: DYNJ900904M; 36) NEURO, Model Number: DYNJ902585; 37) NEURO, Model Number: DYNJ902585A; 38) NEURO - IFCAP 230316, Model Number: DYNJ908393; 39) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 40) NEURO KIT, Model Number: DYNJ909573; 41) NEURO, Model Number: DYNJ910384; 42) NEURO, Model Number: DYNJ910384A; 43) NEURO PACK-LF, Model Number: PHS390015M
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMH970; 2) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMD444; 3) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23AMJ086; 4) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22KMF991; 5) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22HMC764; 6) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22DMD555; 7) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21LMG598; 8) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21KMD971; 9) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21JMH357; 10) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMF497; 11) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GME436; 12) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMA403; 13) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21DBD719; 14) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21CBA213; 15) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24EMI161; 16) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24CMA817; 17) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23KMB758; 18) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMI786; 19) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMA572; 20) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23IME897; 21) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23GMC110; 22) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23EME270; 23) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22OBC508; 24) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22NBA962; 25) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22IBE871; 26) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBF303; 27) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBC967; 28) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBO542; 29) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBA074; 30) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22DBD203; 31) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22BBT015; 32) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21LBL164; 33) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21JBB951; 34) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21HBN643; 35) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBS468; 36) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBG761; 37) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21FBE311; 38) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21DBE120; 39) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBP552; 40) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBA521; 41) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABU817; 42) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABL131; 43) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBG852; 44) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBB221; 45) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABW870; 46) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABL138; 47) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24LBI083; 48) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBK044; 49) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBA532; 50) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24JBS893; 51) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24GBS072; 52) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24EBQ164; 53) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24DBJ890; 54) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBU410; 55) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBA173; 56) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24ABL221; 57) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23KBK072; 58) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23IBS183; 59) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23HBT876; 60) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23GBE625; 61) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23FBE493; 62) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23DBF392; 63) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBP083; 64) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBG764; 65) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23BBU041; 66) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23ABU154; 67) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22LBR466; 68) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22KBB452; 69) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22IBN422; 70) DYKMBNDL145, UDI-DI: 10193489478365(each), 40193489478366(case), Lot Number: 21ABT643; 71) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 24HBF314; 72) DYKMBNDL5, UDI-DI: 10193489477634(each), 40193489477635(case), Lot Number: 21ABQ194; 73) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25KBQ729; 74) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25FBD172; 75) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25DBO558; 76) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25BBM404; 77) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBJ842; 78) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBH040; 79) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24GBK951; 80) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24EBC897; 81) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24DBJ607; 82) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24BBG003; 83) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23LBL844; 84) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23FBP269; 85) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23EBB597; 86) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23ABK051; 87) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 22IBJ928; 88) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23IBR967; 89) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23GBD741; 90) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23EBW271; 91) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23DBQ920; 92) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23CBI776; 93) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22OBL140; 94) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22LBL870; 95) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22JBL998; 96) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBO559; 97) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBF833; 98) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 24DBT971; 99) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 23LBR942; 100) DYNJ0408776Y, UDI-DI: 10195327115852(each), 40195327115853(case), Lot Number: 23DBS739; 101) DYNJ04596K, UDI-DI: 10193489301342(each), 40193489301343(case), Lot Number: 23KMD949; 102) DYNJ35243L, UDI-DI: 10195327638733(each), 40195327638734(case), Lot Number: 24FMB808; 103) DYNJ49098I, UDI-DI: 10193489712100(each), 40193489712101(case), Lot Number: 21BBP868; 104) DYNJ53089B, UDI-DI: 10193489335248(each), 40193489335249(case), Lot Number: 21BBA722; 105) DYNJ53799, UDI-DI: 10889942444557(each), 40889942444558(case), Lot Number: 21ADA264; 106) DYNJ58704A, UDI-DI: 10193489502053(each), 40193489502054(case), Lot Number: 23CBT449; 107) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21KLA157; 108) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA398; 109) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA233; 110) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21GLB218; 111) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 22ABJ128; 112) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21FBS847; 113) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR913; 114) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR912; 115) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBO518; 116) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBJ319; 117) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21CBC497; 118) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23LBN124; 119) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23KBH242; 120) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23HBY836; 121) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23EBM305; 122) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23DBB793; 123) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23CBE668; 124) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22OBE182; 125) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22HBN525; 126) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23LBG606; 127) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23KBP559; 128) DYNJ61157D, UDI-DI: 10195327605919(each), 40195327605910(case), Lot Number: 24ABQ754; 129) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25KBL642; 130) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBR218; 131) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBG888; 132) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25ABG065; 133) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24IBQ689; 134) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24GBA833; 135) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24CBB175; 136) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBX534; 137) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBP375; 138) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22ABL607; 139) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBE011; 140) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB714; 141) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB713; 142) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21KBA371; 143) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21DBV445; 144) DYNJ61998, UDI-DI: 10193489615012(each), 40193489615013(case), Lot Number: 23EBV072; 145) DYNJ64570A, UDI-DI: 10195327242800(each), 40195327242801(case), Lot Number: 22LBK925; 146) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23GBG567; 147) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23FBJ662; 148) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23DBP210; 149) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBT224; 150) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBR140; 151) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23BBS499; 152) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22LBK279; 153) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22IBV281; 154) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22GBR040; 155) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22EBL897; 156) DYNJ80849B, UDI-DI: 10195327443689(each), 40195327443680(case), Lot Number: 23GBF525; 157) DYNJ80849J, UDI-DI: 10198459561245(each), 40198459561246(case), Lot Number: 25KBJ851; 158) DYNJ84653A, UDI-DI: 10195327697419(each), 40195327697410(case), Lot Number: 24GBU616; 159) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22OBE679; 160) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22KBC323; 161) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22JBY355; 162) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBR893; 163) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ992; 164) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ991; 165) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22ELA806; 166) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22EBB675; 167) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22CLA766; 168) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21LBG281; 169) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21JBQ824; 170) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21HBI172; 171) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21GBF913; 172) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25BME471; 173) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25AMG870; 174) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24LMD278; 175) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24KMG047; 176) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMF168; 177) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMB004; 178) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24HMA754; 179) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24FMF700; 180) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMH051; 181) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMB555; 182) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24CBN849; 183) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24ABH283; 184) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23KBH986; 185) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23JBF549; 186) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23HBQ501; 187) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23GBW505; 188) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBV444; 189) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBN975; 190) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABR127; 191) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABC415; 192) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25FMG005; 193) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMJ902; 194) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMG513; 195) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25DME524; 196) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25CMJ212; 197) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25HMI564; 198) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25GMI512; 199) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21GDB745; 200) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21FDA224; 201) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21EDA724; 202) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21CDB697; 203) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25DDB556; 204) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25ADA139; 205) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24LDA154; 206) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24JDC387; 207) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24GDA318; 208) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24CDA135; 209) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23IDB360; 210) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23FDA576; 211) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23ADA425; 212) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22IDA639; 213) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22HDB311; 214) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22GDB053; 215) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22FDB376; 216) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21LDA963; 217) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21JDC066; 218) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21IDB884; 219) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23GDA913; 220) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23FDB736; 221) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23EDB018; 222) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23BDB148; 223) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22LDA043; 224) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDB239; 225) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDA609; 226) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22HDC481; 227) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDB437; 228) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDA427; 229) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22EDA370; 230) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22BDB502; 231) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 23KDA234; 232) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25FLA327; 233) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25DLA489; 234) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24FBF785; 235) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24EBH096; 236) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25DBC086; 237) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF621; 238) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF584; 239) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25BBN770; 240) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25ABA025; 241) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 24JBQ224; 242) PHS390015M, UDI-DI: 10193489333824(each), 40193489333825(case), Lot Number: 20LMD456
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKE1455B, UDI-DI: 10193489760781(each), 40193489760782(case), Lot Number: 22IBV801; 2) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23KMC417; 3) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23IMF495; 4) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23HMG566; 5) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMF416; 6) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMC067; 7) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23EMF635; 8) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMG332; 9) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMC558; 10) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMB706; 11) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23BMC768; 12) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22LMF786; 13) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22JMC784; 14) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22HMD809; 15) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22GMH729; 16) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22FMH954; 17) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22FMD365; 18) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22EMI534; 19) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22EMH737; 20) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21KBP287; 21) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21IBL687; 22) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21CBH946; 23) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21CBH534; 24) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21BBK795
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Number: DYNJ0456816O; 6) L & D PACK-LF, Model Number: DYNJ0456816P; 7) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 8) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 10) DELIVERY PACK-LF, Model Number: DYNJ20546F; 11) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 13) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 14) OB PACK-LF, Model Number: DYNJ26121I; 15) OB DELIVERY PACK, Model Number: DYNJ31024J; 16) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 17) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 18) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 19) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 20) VAG DELIVERY PACK, Model Number: DYNJ38481G; 21) VAG DELIVERY PACK, Model Number: DYNJ38481I; 22) VAG DELIVERY PACK, Model Number: DYNJ38481K; 23) OB PACK 2, Model Number: DYNJ39000D; 24) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 25) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 26) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 27) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 28) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 31) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 32) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 33) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 34) OB-VAG PACK 9128190, Model Number: DYNJ62341; 35) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 36) L & D PACK, Model Number: DYNJ63216A; 37) L&D PACK, Model Number: DYNJ63757A; 38) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 39) MINOR VAG PACK, Model Number: DYNJ68663; 40) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 41) GYN VAGINAL PACK, Model Number: DYNJ68681; 42) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 43) VAGINAL PACK, Model Number: DYNJ69774A; 44) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 45) DELIVERY PACK, Model Number: DYNJ87469A; 46) VAGINAL DELIVERY, Model Number: DYNJ901387A; 47) FLOYD DELIVERY, Model Number: DYNJ906937D; 48) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 49) OB PACK, Model Number: DYNJT5186; 50) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 51) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 52) LABOR AND DELIVERY KIT, Model Number: MNS8950A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKM2326, UDI-DI: 10198459565748(each), 40198459565749(case), Lot Number: 25KMF765; 2) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 24ABK386; 3) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBV905; 4) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBA329; 5) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23HBR548; 6) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23EBP170; 7) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23BBT994; 8) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22LBB693; 9) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22KBS631; 10) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22IBB499; 11) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21LBX453; 12) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21KBM483; 13) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21JBQ910; 14) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBO498; 15) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBE978; 16) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21GBN267; 17) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21FBP760; 18) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21EBE875; 19) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21DBA335; 20) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABT654; 21) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABI982; 22) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 21ABC201; 23) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 21ABM087; 24) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JME434; 25) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JMC541; 26) DYNJ0456816P, UDI-DI: 10195327570545(each), 40195327570546(case), Lot Number: 24HMK119; 27) DYNJ04692S, UDI-DI: 10193489338454(each), 40193489338455(case), Lot Number: 21ADB239; 28) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25DMH878; 29) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25CME932; 30) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25AME014; 31) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24JMB353; 32) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24IMF157; 33) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24GMJ484; 34) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24FMF250; 35) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24DMI443; 36) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24CMB999; 37) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24BMA554; 38) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 23KMJ818; 39) DYNJ16621C, UDI-DI: 10198459421297(each), 40198459421298(case), Lot Number: 25GMD428; 40) DYNJ20546F, UDI-DI: 10193489346084(each), 40193489346085(case), Lot Number: 22IMG976; 41) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22FMB686; 42) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22EMF465; 43) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22DMB332; 44) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22CME094; 45) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22AMA608; 46) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21KMB071; 47) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21JMA483; 48) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21IMD851; 49) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21HMD738; 50) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21GMB531; 51) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21DMD921; 52) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21CME149; 53) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 23AMJ134; 54) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22LMA315; 55) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22IMH408; 56) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22GMH899; 57) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23IBS023; 58) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23IBA365; 59) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23GBU622; 60) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25IBJ589; 61) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25HBM068; 62) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25GBJ925; 63) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25FBE718; 64) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25EBA350; 65) DYNJ31024J, UDI-DI: 10195327139544(each), 40195327139545(case), Lot Number: 22IMF645; 66) DYNJ32139C, UDI-DI: 10193489588576(each), 40193489588577(case), Lot Number: 25DBK245; 67) DYNJ33590F, UDI-DI: 10193489220759(each), 40193489220750(case), Lot Number: 20LDC125; 68) DYNJ35488F, UDI-DI: 10193489803488(each), 40193489803489(case), Lot Number: 23JMB591; 69) DYNJ37331C, UDI-DI: 10889942670512(each), 40889942670513(case), Lot Number: 25GBN237; 70) DYNJ38481G, UDI-DI: 10193489727937(each), 40193489727938(case), Lot Number: 20LMD360; 71) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21LMB210; 72) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21JME107; 73) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21JMC579; 74) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21IMB736; 75) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21GMB665; 76) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21DMB477; 77) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23IMD484; 78) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23HMC301; 79) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23GMD513; 80) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23EMD649; 81) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23CMF409; 82) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMJ499; 83) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC555; 84) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC551; 85) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC268; 86) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22IMG983; 87) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22GMH656; 88) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22EME995; 89) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22CMB285; 90) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22CMA009; 91) DYNJ39000D, UDI-DI: 10195327319656(each), 40195327319657(case), Lot Number: 23JMB120; 92) DYNJ40203A, UDI-DI: 10193489670998(each), 40193489670999(case), Lot Number: 21GDA744; 93) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23GBM044; 94) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23FBM020; 95) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23EBQ232; 96) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23ABO451; 97) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22HBL591; 98) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22FBP490; 99) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22EBD699; 100) DYNJ44720B, UDI-DI: 10195327277512(each), 40195327277513(case), Lot Number: 23FDB511; 101) DYNJ51377G, UDI-DI: 10193489906325(each), 40193489906326(case), Lot Number: 23HBO866; 102) DYNJ51794B, UDI-DI: 10193489644708(each), 40193489644709(case), Lot Number: 21ADA465; 103) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22OBB980; 104) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22EBI837; 105) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22CBW142; 106) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22CBW139; 107) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21LBT403; 108) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21JBY447; 109) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21BBB866; 110) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21ABH443; 111) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23HBT039; 112) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23GBN972; 113) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23FBE833; 114) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23EBJ019; 115) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23CBA634; 116) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23ABO534; 117) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22JBD960; 118) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22IBQ631; 119) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBM755; 120) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBM753; 121) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBA092; 122) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22FBO672; 123) DYNJ61269B, UDI-DI: 10195327054687(each), 40195327054688(case), Lot Number: 22OBD693; 124) DYNJ61574, UDI-DI: 10193489601084(each), 40193489601085(case), Lot Number: 23BMF067; 125) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 23FBR019; 126) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 23DBL820; 127) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 22JBW013; 128) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 22HBT023; 129) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21VBA541; 130) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21LBT378; 131) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21LBT375; 132) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21KBV669; 133) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21IBA396; 134) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21GBK690; 135) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21CBU863; 136) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 23FDA173; 137) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 23EDA759; 138) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 23DDB664; 139) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 23BDA994; 140) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 22IDA469; 141) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 22EDB025; 142) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 22DDC251; 143) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 21IDA188; 144) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 21FDC626; 145) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 21EDB976; 146) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 21BDC025; 147) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 20LDB518; 148) DYNJ62402A, UDI-DI: 10193489926132(each), 40193489926133(case), Lot Number: 23KBF906; 149) DYNJ62402A, UDI-DI: 10193489926132(each), 40193489926133(case), Lot Number: 23IBS478; 150) DYNJ62402A, UDI-DI: 10193489926132(each), 40193489926133(case), Lot Number: 23HBL396; 151) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25JBU638; 152) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25HBG200; 153) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25GBA096; 154) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25CBL912; 155) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25ABR935; 156) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 24KBM262; 157) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 24HBN118; 158) DYNJ63757A, UDI-DI: 10195327542481(each), 40195327542482(case), Lot Number: 23KBG966; 159) DYNJ65145, UDI-DI: 10193489247848(each), 40193489247849(case), Lot Number: 22DDA962; 160) DYNJ65145, UDI-DI: 10193489247848(each), 40193489247849(case), Lot Number: 21LDB251; 161) DYNJ65145, UDI-DI: 10193489247848(each), 40193489247849(case), Lot Number: 21KDA784; 162) DYNJ65145, UDI-DI: 10193489247848(each), 40193489247849(case), Lot Number: 21IDB501; 163) DYNJ68663, UDI-DI: 10193489837346(each), 40193489837347(case), Lot Number: 21LBB336; 164) DYNJ68673A, UDI-DI: 10198459221712(each), 40198459221713(case), Lot Number: 25GBC048; 165) DYNJ68681, UDI-DI: 10193489840209(each), 40193489840200(case), Lot Number: 22ABN829; 166) DYNJ69544A, UDI-DI: 10195327325367(each), 40195327325368(case), Lot Number: 25DBK232; 167) DYNJ69774A, UDI-DI: 10195327328368(each), 40195327328369(case), Lot Number: 23KBM418; 168) DYNJ69774A, UDI-DI: 10195327328368(each), 40195327328369(case), Lot Number: 23IBU502; 169) DYNJ84393, UDI-DI: 10195327361990(each), 40195327361991(case), Lot Number: 25HMC554; 170) DYNJ87469A, UDI-DI: 10198459336522(each), 40198459336523(case), Lot Number: 25GBV520; 171) DYNJ901387A, UDI-DI: 10193489707922(each), 40193489707923(case), Lot Number: 24IBP827; 172) DYNJ906937D, UDI-DI: 10193489963335(each), 40193489963336(case), Lot Number: 23HBQ793; 173) DYNJ906937D, UDI-DI: 10193489963335(each), 40193489963336(case), Lot Number: 23GBV967; 174) DYNJ906937D, UDI-DI: 10193489963335(each), 40193489963336(case), Lot Number: 23EBU945; 175) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25JBR855; 176) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25IBO981; 177) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25IBD649; 178) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25HBO297; 179) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25EBI391; 180) DYNJT5186, UDI-DI: 10198459468797(each), 40198459468798(case), Lot Number: 25HBM919; 181) MNS13550A, UDI-DI: 10653160992875(each), 40653160992876(case), Lot Number: 25DBJ182; 182) MNS13550A, UDI-DI: 10653160992875(each), 40653160992876(case), Lot Number: 23JBU943; 183) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 25DBK156; 184) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 25ABQ083; 185) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 25ABJ839; 186) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24JBU227; 187) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24IBC061; 188) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24HBA805; 189) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24GBK561; 190) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24CBN067; 191) MNS8950A, UDI-DI: 10653160320388(each), 40653160320389(case), Lot Number: 21GBG870
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0510IC; UDI: 04953170308734; All.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A; 9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B; 10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183; 11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A; 12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B; 13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A; 14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39; 15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A; 16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C; 17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46; 18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54; 19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69; 20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A; 21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B; 22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78; 23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A; 24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B; 25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84; 26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C; 27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G; 28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J; 29) BREAST PACK ASC-LF, Model Number: DYNJ36469I; 30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J; 31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F; 32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K; 33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M; 34) BREAST PACK, Model Number: DYNJ50957G; 35) PLASTICS BREAST PACK, Model Number: DYNJ55358G; 36) BHN IMPLANT PACK, Model Number: DYNJ56737A; 37) BREAST PACK, Model Number: DYNJ60210A; 38) PLASTICS PACK 2, Model Number: DYNJ64927F; 39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A; 40) BREAST IMPLANT PACK, Model Number: DYNJ69351; 41) BREAST/TUMMY PACK, Model Number: DYNJ83788; 42) HMSL PLASTICS, Model Number: DYNJ83884B; 43) CHEST/BREAST-LF, Model Number: DYNJ83950A; 44) CHEST/BREAST-LF, Model Number: DYNJ83950B; 45) FREE FLAP A DIRTY, Model Number: DYNJ86165; 46) MAJOR SURGERY PACK, Model Number: DYNJ86816; 47) BREAST REDUCTION PACK, Model Number: DYNJ87444; 48) OMF FREE FLAP, Model Number: DYNJ902005I; 49) BREAST CDS, Model Number: DYNJ902558G; 50) TRUNCAL CONTOURING, Model Number: DYNJ903555D; 51) TRUNCAL CONTOURING, Model Number: DYNJ903555F; 52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C; 53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A; 54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A; 55) FACELIFT, Model Number: DYNJ910462; 56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283; 57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417; 58) PLASTICS PACK-LF, Model Number: PHS806973G
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDB702; 2) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDA228; 3) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25ADB705; 4) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24JDA650; 5) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24IDA403; 6) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23LDC086; 7) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23IDB182; 8) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23HDB786; 9) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21JDB530; 10) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21HDB434; 11) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21GDB740; 12) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21FDA888; 13) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21DDA661; 14) DYKMBNDL117C, UDI-DI: 10195327371104(each), 40195327371105(case), Lot Number: 23DLA834; 15) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21CBE548; 16) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21ABI978; 17) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22IBC515; 18) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22HBN456; 19) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22EBA143; 20) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21IBV640; 21) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21DBN049; 22) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21BBH637; 23) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21ABJ202; 24) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 20LBY951; 25) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23IBB851; 26) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBG507; 27) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBB877; 28) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23GBR888; 29) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 22JBM366; 30) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25LBM160; 31) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25KBR870; 32) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25GBA895; 33) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25EBM448; 34) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBS731; 35) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBK034; 36) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBN216; 37) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBA340; 38) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24IBB931; 39) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBL546; 40) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBD539; 41) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 23LBI220; 42) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22FBC879; 43) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22EBO665; 44) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22BBN306; 45) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21DBC569; 46) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABX025; 47) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABI990; 48) DYKMBNDL182A, UDI-DI: 10195327633806(each), 40195327633807(case), Lot Number: 24BBN507; 49) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25FBO935; 50) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25ABL533; 51) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24KBS891; 52) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBQ469; 53) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBL678; 54) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24DBR913; 55) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21JBJ252; 56) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21CBG305; 57) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21ABI992; 58) DYKMBNDL183A, UDI-DI: 10195327246594(each), 40195327246595(case), Lot Number: 23BBI487; 59) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24GBC829; 60) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBT970; 61) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBJ591; 62) DYKMBNDL34A, UDI-DI: 10193489872033(each), 40193489872034(case), Lot Number: 21DBQ512; 63) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22IBC434; 64) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22GBM861; 65) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22BBU074; 66) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21LBJ742; 67) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21GBR352; 68) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21CBD335; 69) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21ABJ002; 70) DYKMBNDL39A, UDI-DI: 10195327241308(each), 40195327241309(case), Lot Number: 23ABH677; 71) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 25GBW751; 72) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 24JBO020; 73) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21GBR353; 74) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21BBM839; 75) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21ABL308; 76) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21CBG791; 77) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21BBH629; 78) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABO607; 79) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABM089; 80) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABJ589; 81) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 20LBY967; 82) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22JBC409; 83) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22IBR235; 84) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBQ100; 85) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBN457; 86) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21JBS176; 87) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21IBV702; 88) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBO272; 89) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBM983; 90) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBK340; 91) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21GBR324; 92) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21DBC571; 93) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABL345; 94) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABJ013; 95) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23LBA275; 96) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23JBJ695; 97) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23GBL960; 98) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23FBP246; 99) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22KBO876; 100) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBQ852; 101) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBJ150; 102) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC626; 103) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC618; 104) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25KBP763; 105) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25GBL984; 106) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25FBH462; 107) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24KBT018; 108) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24HBM099; 109) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24GBF481; 110) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24EBR715; 111) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22EBS816; 112) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22CBX537; 113) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22BBL848; 114) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABL251; 115) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABG018; 116) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBY278; 117) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBO572; 118) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21KBY757; 119) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21JBJ751; 120) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBV643; 121) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBB097; 122) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21HBK310; 123) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBR398; 124) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBF907; 125) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21DBC549; 126) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21BBK531; 127) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABX017; 128) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABJ216; 129) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 20XBB257; 130) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23LBE774; 131) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23JBN862; 132) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBP831; 133) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBO451; 134) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22KBO921; 135) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBQ856; 136) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ143; 137) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ019; 138) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25FBP527; 139) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBM007; 140) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBE325; 141) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25CBG915; 142) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBU089; 143) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBO685; 144) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBE752; 145) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24LBL035; 146) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24HBD157; 147) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBU597; 148) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBE953; 149) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBR114; 150) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBF892; 151) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22OBH455; 152) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22IBC435; 153) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22HBO907; 154) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBT013; 155) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBF307; 156) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBH705; 157) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBD628; 158) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21JBH111; 159) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21IBT011; 160) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21GBR338; 161) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21GBF538; 162) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21EBH614; 163) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21CBM835; 164) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21ABU822; 165) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21ABM088; 166) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25LBQ326; 167) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25LBP864; 168) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25HBG553; 169) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25GBF486; 170) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25FBB154; 171) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25DBO560; 172) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24LBS883; 173) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24LBI135; 174) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24JBE336; 175) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24IBE175; 176) DYNJ0785310G, UDI-DI: 10193489268966(each), 40193489268967(case), Lot Number: 23KMH075; 177) DYNJ0854650J, UDI-DI: 10193489832426(each), 40193489832427(case), Lot Number: 24IMF274; 178) DYNJ36469I, UDI-DI: 10195327513931(each), 40195327513932(case), Lot Number: 24BBU341; 179) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21CDB475; 180) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21BDB779; 181) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21ADA533; 182) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24KMD041; 183) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24IME867; 184) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24GMA471; 185) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24DMJ046; 186) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24CMD088; 187) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24AMI035; 188) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23LMB124; 189) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23KMA468; 190) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23IMG016; 191) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23HMA900; 192) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23AME665; 193) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22IMF713; 194) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22HMH034; 195) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22GMF684; 196) DYNJ44852K, UDI-DI: 10195327127589(each), 40195327127580(case), Lot Number: 22CMI118; 197) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 25EME929; 198) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 25CME690; 199) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24KME600; 200) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24GMI186; 201) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24CMC758; 202) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24AMB315; 203) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23HME689; 204) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23FMH424; 205) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23DMD096; 206) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23CMF343; 207) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23AMC530; 208) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23AMC374; 209) DYNJ50957G, UDI-DI: 10193489448863(each), 40193489448864(case), Lot Number: 23GBV065; 210) DYNJ55358G, UDI-DI: 10195327173500(each), 40195327173501(case), Lot Number: 23FBN323; 211) DYNJ56737A, UDI-DI: 10193489395594(each), 40193489395595(case), Lot Number: 23CME388; 212) DYNJ60210A, UDI-DI: 10193489985108(each), 40193489985109(case), Lot Number: 21KBP457; 213) DYNJ64927F, UDI-DI: 10195327143091(each), 40195327143092(case), Lot Number: 23FBV335; 214) DYNJ68844A, UDI-DI: 10195327216504(each), 40195327216505(case), Lot Number: 23HMB858; 215) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 24BBL537; 216) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23KBN973; 217) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23JBU455; 218) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23HBY228; 219) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23CBG820; 220) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23BBP453; 221) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23BBD661; 222) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 21LBP376; 223) DYNJ83788, UDI-DI: 10195327305833(each), 40195327305834(case), Lot Number: 23CBO212; 224) DYNJ83884B, UDI-DI: 10198459234620(each), 40198459234621(case), Lot Number: 25GBO120; 225) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 25ABF915; 226) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24JBV233; 227) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24FBL440; 228) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24EBR736; 229) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25DBT195; 230) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25CBF253; 231) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25ABT952; 232) DYNJ86165, UDI-DI: 10195327599324(each), 40195327599325(case), Lot Number: 25ABJ747; 233) DYNJ86816, UDI-DI: 10195327679903(each), 40195327679904(case), Lot Number: 24FMB609; 234) DYNJ87444, UDI-DI: 10198459040122(each), 40198459040123(case), Lot Number: 24GBQ988; 235) DYNJ902005I, UDI-DI: 10195327347710(each), 40195327347711(case), Lot Number: 24DLA844; 236) DYNJ902558G, UDI-DI: 10193489728859(each), 40193489728850(case), Lot Number: 23HMG989; 237) DYNJ903555D, UDI-DI: 10195327084615(each), 40195327084616(case), Lot Number: 22HBF672; 238) DYNJ903555D, UDI-DI: 10195327084615(each), 40195327084616(case), Lot Number: 22GBT713; 239) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBP519; 240) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBP518; 241) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBG876; 242) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23FBN475; 243) DYNJ903849C, UDI-DI: 10195327333355(each), 40195327333356(case), Lot Number: 23DBS608; 244) DYNJ907847A, UDI-DI: 10193489937589(each), 40193489937580(case), Lot Number: 23IMF989; 245) DYNJ907874A, UDI-DI: 10195327241247(each), 40195327241248(case), Lot Number: 23FLA249; 246) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24JMD608; 247) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24IMF741; 248) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24GME383; 249) DYNJT3283, UDI-DI: 10198459323645(each), 40198459323646(case), Lot Number: 25JBI499; 250) DYNJT3417, UDI-DI: 10198459324888(each), 40198459324889(case), Lot Number: 25EBN203; 251) PHS806973G, UDI-DI: 10193489926996(each), 40193489926997(case), Lot Number: 23EBQ702
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJ15668R, UDI-DI: 10195327108502(each), 40195327108503(case), Lot Number: 23HMB037; 2) DYNJ42829B, UDI-DI: 10193489880151(each), 40193489880152(case), Lot Number: 22IBI084; 3) DYNJT3437, UDI-DI: 10198459325076(each), 40198459325077(case), Lot Number: 25FBK633
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; 4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S; 5) GOWN,SIRUS,NONRNF,XLN/XL,20/CS, Model Number: DYNJP2002SL; 6) GOWN,NONRNF,2XL,18/CS, Model Number: DYNJP2003; 7) GOWN,SIRUS,NONRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2003S; 8) GOWN,SIRUS,NONRNF,XLN/2XL,18/CS, Model Number: DYNJP2003SL; 9) GOWN,NONRNF,3XL,18/CS, Model Number: DYNJP2004; 10) GOWN,SIRUS,NONRNF,3XL,18/CS, Model Number: DYNJP2004S; 11) GOWN,NONRNF,SM,30/CS, Model Number: DYNJP2005; 12) GOWN,SIRUS,NONRNF,SM,30/CS, Model Number: DYNJP2005S; 13) GOWN,NONRNF,4XL,18/CS, Model Number: DYNJP2009; 14) GOWN,SIRUS,NONRNF,4XL,18/CS, Model Number: DYNJP2009S; 15) GOWN,ECLIPSE,FABRNF,L,30/CS, Model Number: DYNJP2101; 16) GOWN,SIRUS,FABRNF,L,20/CS, Model Number: DYNJP2101S; 17) GOWN,ECLIPSE,FABRNF,XL,30/CS, Model Number: DYNJP2102; 18) GOWN,SIRUS,FABRNF,XL,20/CS, Model Number: DYNJP2102S; 19) GOWN,ECLIPSE,FABRNF,2XL,18/CS, Model Number: DYNJP2103; 20) GOWN,SIRUS,FABRNF,2XL,18/CS, Model Number: DYNJP2103S; 21) GOWN,ECLIPSE,POLYRNF,L,30/CS, Model Number: DYNJP2201; 22) GOWN,SIRUS,POLYRNF,SETINSLV,L,20/CS, Model Number: DYNJP2201S; 23) GOWN,ECLIPSE,POLYRNF,XL,30/CS, Model Number: DYNJP2202; 24) GOWN,SIRUS,POLYRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2202S; 25) GOWN,ECLIPSE,POLYRNF,2XL,18/CS, Model Number: DYNJP2203; 26) GOWN,SIRUS,POLYRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2203S; 27) GOWN,ECLIPSE,POLYRNF,XLN/L,28/CS, Model Number: DYNJP2204; 28) GOWN,SIRUS,POLYRNF,XLN/LG,20/CS, Model Number: DYNJP2204S; 29) GOWN,ECLIPSE,POLYRNF,XLN/XL,28/CS, Model Number: DYNJP2205; 30) GOWN,SIRUS,POLYRNF,XLN/XL,20/CS, Model Number: DYNJP2205S; 31) GOWN,ECLIPSE,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206; 32) GOWN,SIRUS,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206S; 33) DBQ-GOWN,PREVENTION PLUS,LN/L,ST,24/CS, Model Number: DYNJP2301P; 34) DBQ-GOWN,PREVENTION PLUS,XLN/XL,ST,24/CS, Model Number: DYNJP2302P; 35) DBD-GOWN,PREVENTION PLUS,XLN/2XL,ST,22/C, Model Number: DYNJP2303P; 36) DBD-GOWN,PREVENTION PLUS,L,ST,24/CS, Model Number: DYNJP2306P; 37) DBQ-GOWN,PREVENTION PLUS,XL,ST,24/CS, Model Number: DYNJP2307P; 38) DBQ-GOWN,PREVENTION PLUS,2XL,ST,22/CS, Model Number: DYNJP2308P; 39) GOWN,ORBIS,LVL 3,LRG/XLONG,ST,24/CS, Model Number: DYNJP2361P; 40) GOWN,ORBIS,LVL 3,XLONG/XLARGE,ST,24/CS, Model Number: DYNJP2362P; 41) GOWN,ORBIS,LVL 3,XLNG/XXLARGE,ST,22/CS, Model Number: DYNJP2363P; 42) GOWN,ORBIS,LVL 3,LARGE,ST,24/CS, Model Number: DYNJP2366P; 43) GOWN,ORBIS,LVL 3,XLARGE,ST,24/CS, Model Number: DYNJP2367P; 44) GOWN,ORBIS,LVL 3,XXLARGE,ST,22/CS, Model Number: DYNJP2368P; 45) GOWN,ORBIS,LVL 3,4XL,ST,20/CS, Model Number: DYNJP2369P; 46) GOWN,SIRUS,NONRNF,RAGLAN,L,ST,32/CS, Model Number: DYNJP2401; 47) GOWN,SIRUS,NONRNF,RAGLAN,XL,ST,30/CS, Model Number: DYNJP2402; 48) GOWN,SIRUS,NONRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2403; 49) GOWN,SIRUS,FABRNF,RAGLAN,L,ST,30/CS, Model Number: DYNJP2501; 50) GOWN,SIRUS,FABRNF,RAGLAN,XL,ST,28/CS, Model Number: DYNJP2502; 51) GOWN,SIRUS,FABRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2503; 52
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525050165; 2) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525070175; 3) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525070223; 4) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100047; 5) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100144; 6) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100377; 7) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525020078; 8) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525040212; 9) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525060247; 10) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525080205; 11) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525080306; 12) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525090277; 13) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30522040040; 14) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30524100129; 15) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30524100146; 16) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525010225; 17) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72523120001; 18) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72523120083; 19) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524010047; 20) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524010092; 21) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524120004; 22) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525050067; 23) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525050068; 24) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070040; 25) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070088; 26) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070143; 27) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525070001; 28) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100019; 29) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100119; 30) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100124; 31) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100187; 32) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525100026; 33) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525100098; 34) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525020140; 35) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525020013; 36) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525040083; 37) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060001; 38) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060206; 39) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060207; 40) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080067; 41) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080138; 42) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080226; 43) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090032; 44) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090122; 45) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090257; 46) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525110045; 47) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525110109; 48) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110009; 49) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110013; 50) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110023; 51) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010003; 52) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010007; 53) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010008; 54) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010012; 55) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010015; 56) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520020032; 57) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520030005; 58) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520040007; 59) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520040089; 60) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520050017; 61) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520050018; 62) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060001; 63) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060002; 64) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060003; 65) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060056; 66) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060058; 67) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060061; 68) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060063; 69) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070059; 70) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070079; 71) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070086; 72) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070092; 73) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070115; 74) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070130; 75) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520080058; 76) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520080087; 77) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520080090; 78) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520080092; 79) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520110018; 80) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520110019; 81) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521010001; 82) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521100004; 83) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521100005; 84) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521110002; 85) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521120059; 86) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010006; 87) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010007; 88) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010010; 89) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010034; 90) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010035; 91) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522030014; 92) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522030121; 93) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522030145; 94) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522030146; 95) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522040040; 96) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522040047; 97) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522040049; 98) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522050018; 99) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522060039; 100) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522070017; 101) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522070106; 102) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522100070; 103) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522110015; 104) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522120036; 105) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522120047; 106) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522120183; 107) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523010061; 108) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523010066; 109) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523010107; 110) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523010143; 111) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523020026; 112) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523020034; 113) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523030061; 114) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523050087; 115) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523050108; 116) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523060004; 117) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523060023; 118) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523080049; 119) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523090004; 120) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523100151; 121) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523110078; 122) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523110161; 123) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523120112; 124) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524010007; 125) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524010008; 126) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524050302; 127) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524050303; 128) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524090183; 129) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524100229; 130) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524120001; 131) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520010003; 132) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520020010; 133) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520020022; 134) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520020034; 135) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520020040; 136) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520020052; 137) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520030007; 138) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520030048; 139) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520030053; 140) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520030060; 141) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520030082; 142) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520030084; 143) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520050006; 144) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520050016; 145) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520050067; 146) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520060063; 147) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520060120; 148) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520120005; 149) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520120006; 150) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520120008; 151) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520120009; 152) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520120010; 153) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520120011; 154) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72520120012; 155) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521040002; 156) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521040003; 157) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521040004; 158) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521040005; 159) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521040006; 160) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521040007; 161) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521040040; 162) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521040120; 163) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521040128; 164) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521050001; 165) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521050002; 166) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521050003; 167) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521050004; 168) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521050041; 169) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521050051; 170) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521050054; 171) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521050147; 172) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521060022; 173) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521060032; 174) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521070037; 175) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521070041; 176) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521070047; 177) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521070060; 178) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521070064; 179) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521070070; 180) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521070081; 181) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521080001; 182) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521080007; 183) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521090020; 184) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521100012; 185) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521100020; 186) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521100071; 187) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521100078; 188) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521110058; 189) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521110066; 190) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72521120011; 191) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522020032; 192) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522030001; 193) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522030007; 194) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522030011; 195) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522040011; 196) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522050043; 197) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522060013; 198) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522060073; 199) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522060076; 200) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522060079; 201) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522070043; 202) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522090035; 203) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522090039; 204) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522100009; 205) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522100012; 206) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522110014; 207) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522110056; 208) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522120015; 209) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72522120052; 210) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523010006; 211) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523040038; 212) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523050002; 213) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523050015; 214) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523050046; 215) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523060001; 216) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523060037; 217) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523070022; 218) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523070084; 219) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523080031; 220) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523090016; 221) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523090062; 222) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523100004; 223) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523100064; 224) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523110032; 225) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523120002; 226) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523120072; 227) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523120077; 228) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72523120079; 229) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524010020; 230) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524010088; 231) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524010091; 232) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524020048; 233) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524030001; 234) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524030005; 235) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524030057; 236) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524040003; 237) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524040046; 238) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524050035; 239) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524050036; 240) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524060035; 241) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524070024; 242) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524080005; 243) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524090004; 244) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524090079; 245) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524100005; 246) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524100006; 247) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524100007; 248) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524100069; 249) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524110001; 250) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524110007; 251) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524110033; 252) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72524120005; 253) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525010002; 254) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525050068; 255) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525050166; 256) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525070176; 257) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525070224; 258) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72525070002; 259) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525100048; 260) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525100378; 261) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525020079; 262) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72525020014; 263) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525060021; 264) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525060248; 265) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525080096; 266) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525080206; 267) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525080305; 268) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525080306; 269) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525090065; 270) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525090245; 271) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30524100128; 272) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525010226; 273) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 30525010285; 274) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72523110033; 275) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72523120003; 276) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72524090006; 277) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72524090080; 278) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72524100008; 279) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72524110028; 280) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72524110034; 281) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72524120006; 282) DYNJP2002, UDI-DI: 10080196073658(each), 40080196073659(case), Lot Number: 72525010003; 283) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525050076; 284) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525050077; 285) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525070042; 286) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525070144; 287) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 72525070003; 288) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525100104; 289) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 72525100027; 290) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 72525100099; 291) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525020026; 292) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 72525020015; 293) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525040088; 294) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525040089; 295) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525060003; 296) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525060206; 297) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525060209; 298) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525060210; 299) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525060291; 300) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525080069; 301) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525080143; 302) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525080228; 303) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525090033; 304) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525110081; 305) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525110104; 306) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30525110110; 307) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 72525110001; 308) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520020033; 309) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520040001; 310) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520060057; 311) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520060059; 312) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520070078; 313) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520070087; 314) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520080088; 315) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520080091; 316) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520120003; 317) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520120004; 318) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520120005; 319) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520120006; 320) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520120007; 321) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520120008; 322) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520120009; 323) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520120010; 324) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30520120011; 325) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30521020031; 326) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30521020039; 327) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30521110003; 328) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30521120060; 329) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522010036; 330) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522010037; 331) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522030017; 332) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522030031; 333) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522030120; 334) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522030147; 335) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522040043; 336) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522050019; 337) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522050050; 338) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522060040; 339) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522070016; 340) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522070107; 341) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522090051; 342) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522100075; 343) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522100104; 344) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522110014; 345) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30522120038; 346) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30523010062; 347) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30523010067; 348) DYNJP2002S, UDI-DI: 10080196304677(each), 40080196304678(case), Lot Number: 30523010110; 349) DYNJP2002S, UDI-DI: 10080196304677(each),
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0545PC; UDI: 04953170308635; All Lots.
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-LF, Model Number: CDS984543G; 7) ROBOTIC-LF, Model Number: CDS984543I; 8) GYN CDS, Model Number: CDS984860F; 9) GYN LAP PELVI, Model Number: CDS985423G; 10) GYN KIT, Model Number: DYKM1657A; 11) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 12) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 13) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 14) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 15) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 16) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 17) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 18) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 19) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 20) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; 21) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92; 22) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92A; 23) KIT GYN ABDOMINAL, Model Number: DYKMBNDL92C; 24) KIT GYN LAP, Model Number: DYKMBNDL94; 25) KIT GYN LAP, Model Number: DYKMBNDL94A; 26) KIT GYN LAP, Model Number: DYKMBNDL94C; 27) KIT GYN LAP, Model Number: DYKMBNDL94D; 28) GYN LAPAROSCOPY PACK-LF, Model Number: DYNJ0281948N; 29) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372F; 30) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372G; 31) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372I; 32) HEALTH ALL GYN LAP PACK-LF, Model Number: DYNJ28252G; 33) GYN OPERATIVE LAP PACK-LF, Model Number: DYNJ30005G; 34) OB PACK, Model Number: DYNJ32706B; 35) ROBOTIC UROLOGY-RF, Model Number: DYNJ38844N; 36) ENSEMBLE GYNE LAPAROTOMIE-LF, Model Number: DYNJ47550C; 37) GYN LAP PACK, Model Number: DYNJ47714A; 38) TASC GYN LAP, Model Number: DYNJ49191B; 39) ROBOTIC PACK, Model Number: DYNJ49705K; 40) GYN LAPAROSCOPY PACK, Model Number: DYNJ50348F; 41) NWH GYN LAPAROSCOPY, Model Number: DYNJ50439F; 42) FH LAPAROSCOPIC GYN PK-LF, Model Number: DYNJ51795F; 43) GYN LAPAROSCOPY PACK, Model Number: DYNJ52569B; 44) LAVH PACK, Model Number: DYNJ55862; 45) PK, GEN-LAPAROSCOPY, Model Number: DYNJ57607A; 46) GYN LAPAROSCOPY MRNGSD, Model Number: DYNJ58321A; 47) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079B; 48) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079C; 49) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079D; 50) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079F; 51) GYN DAVINCI PACK, Model Number: DYNJ64266; 52) DAVINCI PACK, Model Number: DYNJ66298D; 53) GYN LAPAROSCOPY, Model Number: DYNJ67269; 54) GENERAL GYN PACK, Model Number: DYNJ68710; 55) LAP GYN PACK, Model Number: DYNJ69419A; 56) LAP GYN PACK, Model Number: DYNJ69419D; 57) GYN LAPAROSCOPY, Model Number: DYNJ81492A; 58) PK, ROBOTIC GYN & GU-ROSE MEDI, Model Number: DYNJ81761A; 59) GYN PACK, Model Number: DYNJ83475A; 60) ROBOTIC XI PACK, Model Number: DYNJ84783; 61) GYN PACK, Model Number: DYNJ86195A; 62) GYN LAPAROSCOPY, Model Number: DYNJ900262A; 63) D&C HYSTEROSCOPY, Model Number: DYNJ901133A; 64) GYN LAPAROSCOPY, Model Number: DYNJ901559J; 65) GYN ENDOSCOPY-LF, Model Number: DYNJ901812J; 66) GYN LITHOTOMY-LF, Model Number: DYNJ902711M; 67) GENERAL ROBOTIC, Model Number: DYNJ905066B; 68) TRINITY C-SEC W/LINEN CDS, Model Number: DYNJ905269G; 69) KIT GYN LAPAROSCOPY RFD, Model Number: DYNJ906322D; 70) GYN LAP LH, Model Number: DYNJ906452C; 71) GYN LAP LH, Model Number: DYNJ906452D; 72) GYN LAP LH, Model Number: DYNJ906452F; 73) FLOYD LITH GYN, Model Number: DYNJ906926B; 74) GYN LAPAROSCOPY-MRMC, Model Number: DYNJ907753F; 75) GYN LAPAROSCOPY-SFMC, Model Number: DYNJ907771C; 76) LAP/GYN ROBOTICS, Model Number: DYNJ908887B; 77) LAP/GYN ROBOTICS, Model Number: DYNJ908887C;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS982893I, UDI-DI: 10889942208050(each), 40889942208051(case), Lot Number: 24IBO240; 2) CDS983300J, UDI-DI: 10193489425048(each), 40193489425049(case), Lot Number: 21CDB781; 3) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBX440; 4) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBN644; 5) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23ABC549; 6) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22OBM422; 7) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22KBD152; 8) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22JBC547; 9) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22HBV491; 10) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22GBP114; 11) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22FBV462; 12) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22BBL450; 13) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21VBA272; 14) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21IBM804; 15) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21HBN807; 16) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21GBI171; 17) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21EBA117; 18) CDS984543D, UDI-DI: 10195327072322(each), 40195327072323(case), Lot Number: 22CBC587; 19) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22OBL925; 20) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22KMD619; 21) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22JMA223; 22) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMG671; 23) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMB259; 24) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22GBD616; 25) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 24BMH483; 26) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23LMA864; 27) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23JMC376; 28) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23IMA629; 29) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMH282; 30) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMF425; 31) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23FMI171; 32) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23EMI460; 33) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23DMA508; 34) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23CMC582; 35) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23BMD680; 36) CDS984543I, UDI-DI: 10195327637071(each), 40195327637072(case), Lot Number: 24CMH050; 37) CDS984860F, UDI-DI: 10193489261974(each), 40193489261975(case), Lot Number: 21ADB205; 38) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21DBV243; 39) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH547; 40) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH282; 41) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25LBN225; 42) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25HBS386; 43) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25FBS108; 44) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25DBN805; 45) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21JBD206; 46) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21GBP406; 47) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21EBA097; 48) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21BBG514; 49) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21ABI962; 50) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABW347; 51) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABO060; 52) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABM086; 53) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24DBA349; 54) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24CBF889; 55) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24JBB328; 56) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24IBV184; 57) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24GBK948; 58) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24FBC411; 59) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24DBS388; 60) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22HBL832; 61) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22FBI695; 62) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22CBX517; 63) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22BBR618; 64) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBY301; 65) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBP646; 66) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBX803; 67) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBC127; 68) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21HBK337; 69) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21FBP762; 70) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21EBG218; 71) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBP181; 72) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBA024; 73) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABL615; 74) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABJ213; 75) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25HBB957; 76) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25GBX843; 77) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25FBR662; 78) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBI207; 79) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBF533; 80) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24JBD270; 81) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24DBV608; 82) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24CBJ465; 83) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24ABX678; 84) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23LBE369; 85) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23KBA328; 86) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 22JBC546; 87) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22HBP253; 88) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22CBX518; 89) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL299; 90) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL283; 91) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21KBQ606; 92) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21JBJ225; 93) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21IBL095; 94) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBU222; 95) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBP369; 96) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21EBK837; 97) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21BBG518; 98) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21ABI984; 99) DYKMBNDL168A, UDI-DI: 10195327240806(each), 40195327240807(case), Lot Number: 23FBJ346; 100) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBQ333; 101) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBG179; 102) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25HBC798; 103) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25FBJ143; 104) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25BBF014; 105) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25ABS671; 106) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24HBK278; 107) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBV008; 108) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBJ568; 109) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22HBB985; 110) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22GBZ017; 111) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21LBJ751; 112) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21IBO770; 113) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21HBK341; 114) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21FBP714; 115) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21BBG520; 116) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21ABJ086; 117) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22HLA664; 118) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ELB163; 119) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ELA227; 120) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22DLB036; 121) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22CLA119; 122) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22BLA918; 123) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ALA331; 124) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ALA125; 125) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21LLA284; 126) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21LLA163; 127) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21JLA896; 128) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21HLA598; 129) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA658; 130) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA352; 131) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA256; 132) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21DLA017; 133) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21BLA496; 134) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ABJ861; 135) DYKMBNDL92A, UDI-DI: 10195327241209(each), 40195327241200(case), Lot Number: 22KLA731; 136) DYKMBNDL92A, UDI-DI: 10195327241209(each), 40195327241200(case), Lot Number: 22JLA665; 137) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25ILA134; 138) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25HLA275; 139) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25GLA701; 140) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25ELA660; 141) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25DLB036; 142) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25BLA797; 143) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24KLB092; 144) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24KLA506; 145) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24KLA194; 146) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24JLB140; 147) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24JLA881; 148) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24HLB219; 149) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24HLB142; 150) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 22HBH516; 151) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 22FBK394; 152) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21IBV704; 153) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21HBO271; 154) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21GBB013; 155) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21CBS045; 156) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21CBB287; 157) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21ABM148; 158) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 20LBY985; 159) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23BBI491; 160) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23ABO813; 161) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23ABK219; 162) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23ABJ591; 163) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 22LBS837; 164) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25CBR621; 165) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25BBA805; 166) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25ABN371; 167) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25ABH279; 168) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24LBN994; 169) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24KBA746; 170) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24IBE086; 171) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24EBV430; 172) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24DBR903; 173) DYKMBNDL94D, UDI-DI: 10198459350641(each), 40198459350642(case), Lot Number: 25EBN175; 174) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24HBX130; 175) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24HBA113; 176) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24EBT021; 177) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24EBM495; 178) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24DBL074; 179) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24CBM999; 180) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24BBH633; 181) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24ABI719; 182) DYNJ0347372F, UDI-DI: 10195327213176(each), 40195327213177(case), Lot Number: 22GBR392; 183) DYNJ0347372G, UDI-DI: 10195327266028(each), 40195327266029(case), Lot Number: 23DBP818; 184) DYNJ0347372G, UDI-DI: 10195327266028(each), 40195327266029(case), Lot Number: 22KBU586; 185) DYNJ0347372I, UDI-DI: 10195327418335(each), 40195327418336(case), Lot Number: 23IBK088; 186) DYNJ0347372I, UDI-DI: 10195327418335(each), 40195327418336(case), Lot Number: 23GBO695; 187) DYNJ28252G, UDI-DI: 10198459088124(each), 40198459088125(case), Lot Number: 25CBC137; 188) DYNJ28252G, UDI-DI: 10198459088124(each), 40198459088125(case), Lot Number: 25BBP572; 189) DYNJ30005G, UDI-DI: 10193489601794(each), 40193489601795(case), Lot Number: 21DMA051; 190) DYNJ32706B, UDI-DI: 10195327364304(each), 40195327364305(case), Lot Number: 23EMB628; 191) DYNJ38844N, UDI-DI: 10195327243166(each), 40195327243167(case), Lot Number: 23HBI619; 192) DYNJ38844N, UDI-DI: 10195327243166(each), 40195327243167(case), Lot Number: 23DBI585; 193) DYNJ47550C, UDI-DI: 10195327209964(each), 40195327209965(case), Lot Number: 23DBD093; 194) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 25KBF492; 195) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 24FBG329; 196) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 24CBQ847; 197) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 23HBO785; 198) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 23FBU806; 199) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 23FBH830; 200) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 23CMB495; 201) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22KMH193; 202) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22HMC351; 203) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22HMA973; 204) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22EMA211; 205) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22BMH522; 206) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21KMG274; 207) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21JMH124; 208) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21JMF391; 209) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21GMD682; 210) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21AMA809; 211) DYNJ49705K, UDI-DI: 10195327020347(each), 40195327020348(case), Lot Number: 22IMI306; 212) DYNJ50348F, UDI-DI: 10195327406349(each), 40195327406340(case), Lot Number: 23IMD230; 213) DYNJ50439F, UDI-DI: 10193489704921(each), 40193489704922(case), Lot Number: 22EBC737; 214) DYNJ51795F, UDI-DI: 10193489475937(each), 40193489475938(case), Lot Number: 21ADA184; 215) DYNJ51795F, UDI-DI: 10193489475937(each), 40193489475938(case), Lot Number: 20LDC148; 216) DYNJ52569B, UDI-DI: 10193489685190(each), 40193489685191(case), Lot Number: 23EBS784; 217) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 23BBA462; 218) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22LBD784; 219) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22HBV228; 220) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22GBJ776; 221) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22ABC476; 222) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 21JBR818; 223) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 21IBG462; 224) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 21CBU815; 225) DYNJ57607A, UDI-DI: 10193489206678(each), 40193489206679(case), Lot Number: 21GME150; 226) DYNJ57607A, UDI-DI: 10193489206678(each), 40193489206679(case), Lot Number: 21FMB889; 227) DYNJ57607A, UDI-DI: 10193489206678(each), 40193489206679(case), Lot Number: 21EMB589; 228) DYNJ58321A, UDI-DI: 10193489489316(each), 40193489489317(case), Lot Number: 22ABG197; 229) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 22AME373; 230) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21JMF224; 231) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21HMD002; 232) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21EMF383; 233) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21DMB839; 234) DYNJ63079C, UDI-DI: 10195327102180(each), 40195327102181(case), Lot Number: 23GMB716; 235) DYNJ63079C, UDI-DI: 10195327102180(each), 40195327102181(case), Lot Number: 23EMI624; 236) DYNJ63079D, UDI-DI: 10195327505677(each), 40195327505678(case), Lot Number: 24BME368; 237) DYNJ63079D, UDI-DI: 10195327505677(each), 40195327505678(case), Lot Number: 23JMB435; 238) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 25JMK630; 239) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 25JMH582; 240) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 25AMH256; 241) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 24JMD681; 242) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 24HMH481; 243) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 24HMC603; 244) DYNJ64266, UDI-DI: 10193489795516(each), 40193489795517(case), Lot Number: 21ADA447; 245) DYNJ66298D, UDI-DI: 10195327095895(each), 40195327095896(case), Lot Number: 23IBW233; 246) DYNJ67269, UDI-DI: 10193489394696(each), 40193489394697(case), Lot Number: 22KBG504; 247) DYNJ68710, UDI-DI: 10193489842906(each), 40193489842907(case), Lot Number: 22ABM641; 248) DYNJ69419A, UDI-DI: 10195327223588(each), 40195327223589(case), Lot Number: 23DBK434; 249) DYNJ69419A, UDI-DI: 10195327223588(each), 40195327223589(case), Lot Number: 23ABS144; 250) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24KMH362; 251) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24KME386; 252) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24GMG805; 253) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24GMC135; 254) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24EMD677; 255) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24EMC427; 256) DYNJ81492A, UDI-DI: 10195327348830(each), 40195327348831(case), Lot Number: 23BBT116; 257) DYNJ81761A, UDI-DI: 10195327574468(each), 40195327574469(case), Lot Number: 24FMF687; 258) DYNJ83475A, UDI-DI: 10195327460938(each), 40195327460939(case), Lot Number: 23HBY488; 259) DYNJ84783, UDI-DI: 10195327417949(each), 40195327417940(case), Lot Number: 23IBU517; 260) DYNJ86195A, UDI-DI: 10195327682286(each), 40195327682287(case), Lot Number: 24EBD237; 261) DYNJ900262A, UDI-DI: 10195327477820(each), 40195327477821(case), Lot Number: 23KBU736; 262) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 22JBR884; 263) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21KBP568; 264) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21KBF079; 265) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21JBV891; 266) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21JBM245; 267) DYNJ901559J, UDI-DI: 10193489235890(each), 40193489235891(case), Lot Number: 21EBR740; 268) DYNJ901559J, UDI-DI: 10193489235890(each), 40193489235891(case), Lot Number: 21CBH289; 269) DYNJ901812J, UDI-DI: 10193489814163(each), 40193489814164(case), Lot Number: 21FDB236; 270) DYNJ901812J, UDI-DI: 10193489814163(each), 40193489814164(case), Lot Number: 21BDA744; 271) DYNJ901812J, UDI-DI: 10193489814163(each), 40193489814164(case), Lot Number: 21ADB190; 272) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25GBR954; 273) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25EBK653; 274) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25DBB182; 275) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25ABS755; 276) DYNJ905066B, UDI-DI: 10195327098674(each), 40195327098675(case), Lot Number: 23BMF722; 277) DYNJ905066B, UDI-DI: 10195327098674(each), 40195327098675(case), Lot Number: 23BMB931; 278) DYNJ905269G, UDI-DI: 10193489337112(each), 40193489337113(case), Lot Number: 21BBD394; 279) DYNJ905269G, UDI-DI: 10193489337112(each), 40193489337113(case), Lot Number: 21ABH751; 280) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 23FBE986; 281) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 23EBQ671; 282) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 23DBT141; 283) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 22GBL545; 284) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23FBP128; 285) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23DBM357; 286) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23BBB047; 287) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23BBA689; 288) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25IBI139; 289) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25HBO792; 290) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25GBB683; 291) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25EBA889; 292) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25BBO090; 293) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25ABT788; 294) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24LBN196; 295) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24KBJ970; 296) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24IBN246; 297) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24HBM625; 298) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24FBJ836; 299) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24DBT181; 300) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24CBS248; 301) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24BBN302; 302) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24ABD306; 303) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23LBJ184; 304) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23JBT789; 305) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23IBO509; 306) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23HBO123; 307) DYNJ906452F, UDI-DI: 10198459575303(each), 40198459575304(case), Lot Number: 25KBG657; 308) DYNJ906926B, UDI-DI: 10193489921366(each), 40193489921367(case), Lot Number: 23EBN137; 309) DYNJ907753F, UDI-DI: 10195327194482(each), 40195327194483(case), Lot Number: 22LBN185; 310) DYNJ907771C, UDI-DI: 10195327120399(each), 40195327120390(case), Lot Number: 22LBP170; 311) DYNJ908887B, UDI-DI: 10195327620158(each), 40195327620159(case), Lot Number: 24DBD796; 312) DYNJ908887B, UDI-DI: 10195327620158(each), 40195327620159(case), Lot Number: 24CBP744; 313) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24LBP187; 314) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24JBP902; 315) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24HBI648; 316) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24GBK492; 317) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24EBM187; 318) DYNJ909398A, UDI-DI: 10195327338190(each), 40195327338191(case), Lot Number: 23KME175; 319) DYNJ909398A, UDI-DI: 10195327338190(each), 40195327338191(case), Lot Number: 23JMB528; 320) DYNJ909398A, UDI-DI: 10195327338190(each), 40195327338191(case), Lot Number: 23HMI269; 321) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24HMA202; 322) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24DMI073; 323) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24CMI706; 324) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24BMA251; 325) DYNJ910536, UDI-DI: 10198459029554(each), 40198459029555(case), Lot Number: 24GBA620; 326) DYNJ910536A, UDI-DI: 10198459054358(each), 40198459054359(case), Lot Number: 24IBE833; 327) DYNJ910589, UDI-DI: 10198459040894(each), 40198459040895(case), Lot Number: 24HBF839; 328) DYNJ910594, UDI-DI: 10198459041327(each), 40198459041328(case), Lot Number: 24HBF837; 329) DYNJ911567, UDI-DI: 10198459409004(each), 40198459409005(case), Lot Number: 25HBB593; 330) DYNJ9701096G, UDI-DI: 10193489779257(each), 40193489779258(case), Lot Number: 21DMF113; 331) DYNJ9701096G, UDI-DI: 10193489779257(each), 40193489779258(case), Lot Number: 21CKA812; 332) DYNJ9701096G, UDI-DI: 10193489779257(each), 40193489779258(case), Lot Number: 21CKA647; 333) DYNJ9701096I, UDI-DI: 10193489939651(each), 40193489939652(case), Lot Number: 22AMC654; 334) DYNJT3381, UDI-DI: 10198459325205(each), 40198459325206(case), Lot Number: 25EBK724
Feb 25, 2026
View details →Baxter healthcare corporation
High PriorityActive
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Pumps were released without full testing being performed, including occlusion alarm testing.
Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2025051290; 2) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2025031190; 3) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2023062390; 4) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2023101290; 5) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2022030390; 6) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2022072590; 7) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case), Lot Number: 2020042290; 8) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case), Lot Number: 2020052290; 9) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case), Lot Number: 2020072290; 10) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case), Lot Number: 2020082690; 11) DT8670A, UDI-DI: 00653160177473(each), 10653160177470(case), Lot Number: 2020051390
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23FDC392; 2) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDB552; 3) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDA474; 4) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 22LDA486; 5) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24KDB955; 6) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24IDB525; 7) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24GDB922; 8) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24FDB302; 9) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24EDB468; 10) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24DDB769; 11) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB829; 12) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB327; 13) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDA984; 14) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 23HDB637
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJ50806L, UDI-DI: 10195327344672(each), 40195327344673(case), Lot Number: 23FBK937
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25IFA006; 2) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24GFA027; 3) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24FFA115; 4) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24BFA115; 5) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23LFA050; 6) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23GFA079; 7) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA070; 8) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA007; 9) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23DFA024; 10) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23CFA070; 11) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA124; 12) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA006; 13) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA090; 14) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA049; 15) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22LFA068; 16) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22JFA111; 17) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22IFA036; 18) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22DFA081; 19) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22CFA086; 20) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22BFA066; 21) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21KFA114; 22) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA139; 23) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA039; 24) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21IFA100; 25) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21HFA112; 26) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21GFA025; 27) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21FFA074; 28) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21EFA047; 29) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21BFA109
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B; 9) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174; 10) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174A; 11) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174B; 12) KIT PEDS HEAD AND NECK, Model Number: DYKMBNDL196; 13) KIT OMF LEFORTE, Model Number: DYKMBNDL1A; 14) KIT OMF LEFORTE, Model Number: DYKMBNDL1B; 15) KIT OMF LEFORTE, Model Number: DYKMBNDL1C; 16) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32; 17) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32A; 18) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32B; 19) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66A; 20) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66B; 21) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88A; 22) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88B; 23) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88C; 24) KIT GEN SURG LAP VENTRA, Model Number: DYKMBNDL96C; 25) MINOR ENT PACK, Model Number: DYNJ01831I; 26) ENT BASIC PACK-LF, Model Number: DYNJ0387711F; 27) D AND C PACK-LF, Model Number: DYNJ0855090P; 28) CSS SINUS PACK, Model Number: DYNJ17005I; 29) CSS HEAD & NECK PACK, Model Number: DYNJ26780I; 30) NASALPLASTY #61-RF, Model Number: DYNJ27320V; 31) MASTOID PACK-WINTER PARK-LF, Model Number: DYNJ32060C; 32) T&A PACK, Model Number: DYNJ32809I; 33) HEAD AND NECK PACK, Model Number: DYNJ41169; 34) SIMPLE NECK DISSECTION, Model Number: DYNJ47481C; 35) ENT PACK, Model Number: DYNJ47882F; 36) ENT PACK, Model Number: DYNJ48401C; 37) ENT PACK, Model Number: DYNJ51934A; 38) PK,ORTHO-EXTREMITY-LOSROBLES, Model Number: DYNJ52916A; 39) HEAD & NECK PACK, Model Number: DYNJ54964A; 40) HEAD & NECK PACK, Model Number: DYNJ54964B; 41) ENT - MINOR ENT PACK-LF, Model Number: DYNJ56840B; 42) GLENNON HEAD AND NECK PACK-LF, Model Number: DYNJ57200C; 43) ENT PACK, Model Number: DYNJ57688F; 44) RF T AND A PACK, Model Number: DYNJ61393A; 45) T & A PACK, Model Number: DYNJ61935D; 46) ENT PACK, Model Number: DYNJ62093B; 47) ENT PACK, Model Number: DYNJ64024B; 48) OSCLJ HEAD AND NECK PACK, Model Number: DYNJ66509A; 49) HEAD AND NECK PACK, Model Number: DYNJ67208; 50) HEAD & NECK PACK, Model Number: DYNJ67328B; 51) PEDS HEAD AND NECK PACK, Model Number: DYNJ69746B; 52) NASAL PACK, Model Number: DYNJ81280A; 53) ENT-PLASTICS PACK, Model Number: DYNJ84258A; 54) ENT-PLASTICS PACK, Model Number: DYNJ84258B; 55) HEAD & NECK PACK, Model Number: DYNJ85078A; 56) ENT PACK, Model Number: DYNJ86194A; 57) EENT PACK, Model Number: DYNJ86235; 58) ENT PACK, Model Number: DYNJ87378; 59) ENT PACK, Model Number: DYNJ87378A; 60) ENT PACK, Model Number: DYNJ87378D; 61) ENT SPLIT PACK, Model Number: DYNJ87451; 62) ENT SINUS PACK, Model Number: DYNJ88498; 63) NASAL, Model Number: DYNJ902993F; 64) ENDO SINUS-MIDTOWN, Model Number: DYNJ905866; 65) T A, Model Number: DYNJ906292B; 66) THYROID, Model Number: DYNJ906841A; 67) THYROID - SMH AMB, Model Number: DYNJ907739B; 68) ENT, Model Number: DYNJ911623; 69) HEAD AND NECK PACK, Model Number: DYNJT5739; 70) RO MEDIASTINAL PACK-LF, Model Number: PHS393087007C
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21IBD399; 2) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21HBO921; 3) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22JBW315; 4) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22GBE731; 5) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22FBX804; 6) CDS983782C, UDI-DI: 10193489592047(each), 40193489592048(case), Lot Number: 21DKA756; 7) DYKE1456D, UDI-DI: 10195327639938(each), 40195327639939(case), Lot Number: 24CBK289; 8) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25HLA345; 9) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25FLA904; 10) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25DLB145; 11) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25CLB002; 12) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24DLA606; 13) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24ALA266; 14) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBS478; 15) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBO537; 16) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21DBJ855; 17) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21CBD340; 18) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21BBG062; 19) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21ABK323; 20) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22GBH498; 21) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22FBT038; 22) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22EBS812; 23) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22DBL428; 24) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22CBX230; 25) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22BBA231; 26) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22ABG015; 27) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBB014; 28) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBA009; 29) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21IBP624; 30) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21HBF494; 31) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21GBE737; 32) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25GBX739; 33) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25EBH975; 34) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25DBQ008; 35) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25BBM402; 36) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25ABK769; 37) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24KBJ157; 38) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24HBU706; 39) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBR935; 40) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBD477; 41) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24EBF125; 42) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24DBV609; 43) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24ABL113; 44) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBT911; 45) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBQ487; 46) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBV381; 47) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBT877; 48) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23FBG212; 49) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23EBS366; 50) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23DBM060; 51) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23ABQ109; 52) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22KBH786; 53) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22IBU647; 54) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21FBQ554; 55) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21BBP836; 56) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21ABH824; 57) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22EBO543; 58) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22BBS429; 59) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 21LBY299; 60) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 25LBM606; 61) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24EBP260; 62) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24DBB691; 63) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24CBA389; 64) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23JBN238; 65) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23ABH675; 66) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22LBI002; 67) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22KBK464; 68) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBT411; 69) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBS041; 70) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBM511; 71) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBH559; 72) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBF521; 73) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21BBG851; 74) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21ABP337; 75) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 23BLA884; 76) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22KLA452; 77) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22JLB001; 78) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA924; 79) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA791; 80) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25DLA251; 81) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25CLA312; 82) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25BLA837; 83) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24JLA055; 84) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24ILA560; 85) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLB156; 86) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLA924; 87) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24GLA055; 88) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24FLA349; 89) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23LLA422; 90) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23KLA620; 91) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23JLA058; 92) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23ILA756; 93) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23HLA624; 94) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23DLA495; 95) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23CLA769; 96) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA386; 97) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA035; 98) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA843; 99) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA232; 100) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA179; 101) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21FBT798; 102) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21EBM706; 103) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21DBK216; 104) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21CBS031; 105) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21BBL111; 106) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ985; 107) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ862; 108) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22HBP925; 109) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBQ602; 110) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBF522; 111) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22FBE193; 112) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBQ053; 113) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBO633; 114) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21JBJ743; 115) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21IBD784; 116) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBP188; 117) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBC830; 118) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24EBU213; 119) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24DBU451; 120) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24CBR483; 121) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABK306; 122) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABH039; 123) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23LBP166; 124) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23IBA611; 125) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBX217; 126) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBH678; 127) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23FBP266; 128) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBT500; 129) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBB247; 130) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23DBP706; 131) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23BBS356; 132) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 22JBW957; 133) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 22IBL167; 134) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24DBD514; 135) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24CBD159; 136) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24BBT350; 137) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 23LBF184; 138) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22LBN128; 139) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22JBQ673; 140) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22JBG017; 141) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25LBI754; 142) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25JBF754; 143) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25CBR258; 144) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25ABH117; 145) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24LBT153; 146) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24KBT017; 147) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24IBO509; 148) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24HBH734; 149) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24FBG015; 150) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24DBR155; 151) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23CBN843; 152) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23CBJ801; 153) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23ABK217; 154) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22LBR829; 155) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22JBW066; 156) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22JBD610; 157) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25FBT988; 158) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25EBU506; 159) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25EBK536; 160) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25CBI877; 161) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25ABS392; 162) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25ABH118; 163) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24JBX567; 164) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24JBL602; 165) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24GBU190; 166) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24GBN944; 167) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24EBU598; 168) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24EBF126; 169) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24DBS395; 170) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24BBL266; 171) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24BBJ842; 172) DYKMBNDL88C, UDI-DI: 10198459584886(each), 40198459584887(case), Lot Number: 25LBP011; 173) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 25GBG516; 174) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24KBA441; 175) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24IBQ080; 176) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24HBN645; 177) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24HBJ497; 178) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24GBH580; 179) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24DBR908; 180) DYNJ01831I, UDI-DI: 10889942572502(each), 40889942572503(case), Lot Number: 21EMA909; 181) DYNJ0387711F, UDI-DI: 10198459005893(each), 40198459005894(case), Lot Number: 24HMA304; 182) DYNJ0855090P, UDI-DI: 10198459605826(each), 40198459605827(case), Lot Number: 25LMA083; 183) DYNJ17005I, UDI-DI: 10193489241860(each), 40193489241861(case), Lot Number: 23HBV662; 184) DYNJ26780I, UDI-DI: 10193489238822(each), 40193489238823(case), Lot Number: 23GBP197; 185) DYNJ27320V, UDI-DI: 10195327104719(each), 40195327104710(case), Lot Number: 22LBQ654; 186) DYNJ32060C, UDI-DI: 10884389637265(each), 40884389637266(case), Lot Number: 22LBS348; 187) DYNJ32809I, UDI-DI: 10193489448795(each), 40193489448796(case), Lot Number: 22IBP091; 188) DYNJ41169, UDI-DI: 10884389906699(each), 40884389906690(case), Lot Number: 22LBR515; 189) DYNJ47481C, UDI-DI: 10889942544028(each), 40889942544029(case), Lot Number: 21BBP023; 190) DYNJ47882F, UDI-DI: 10195327319472(each), 40195327319473(case), Lot Number: 23HME434; 191) DYNJ48401C, UDI-DI: 10198459175749(each), 40198459175740(case), Lot Number: 25ABD063; 192) DYNJ51934A, UDI-DI: 10193489584776(each), 40193489584777(case), Lot Number: 23HMG725; 193) DYNJ52916A, UDI-DI: 10195327311735(each), 40195327311736(case), Lot Number: 24GMK024; 194) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25DBB366; 195) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25BBM674; 196) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 24LBN788; 197) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 24IBV894; 198) DYNJ54964B, UDI-DI: 10198459428814(each), 40198459428815(case), Lot Number: 25KBH303; 199) DYNJ54964B, UDI-DI: 10198459428814(each), 40198459428815(case), Lot Number: 25HBR203; 200) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 22GBJ777; 201) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 21IBQ699; 202) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 21IBQ696; 203) DYNJ57200C, UDI-DI: 10198459306754(each), 40198459306755(case), Lot Number: 25EMA242; 204) DYNJ57688F, UDI-DI: 10195327034610(each), 40195327034611(case), Lot Number: 22HMH769; 205) DYNJ61393A, UDI-DI: 10193489444179(each), 40193489444170(case), Lot Number: 23CMB523; 206) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 24BBK459; 207) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 24BBI869; 208) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 23LBP950; 209) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 23HBC470; 210) DYNJ62093B, UDI-DI: 10193489969351(each), 40193489969352(case), Lot Number: 23ABE410; 211) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24KBS794; 212) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24HBO119; 213) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24EBS530; 214) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24DBV691; 215) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24ABK239; 216) DYNJ66509A, UDI-DI: 10193489462708(each), 40193489462709(case), Lot Number: 24HMA316; 217) DYNJ67208, UDI-DI: 10193489391671(each), 40193489391672(case), Lot Number: 20XBA769; 218) DYNJ67328B, UDI-DI: 10195327271503(each), 40195327271504(case), Lot Number: 23HMD036; 219) DYNJ69746B, UDI-DI: 10195327475222(each), 40195327475223(case), Lot Number: 24JLA247; 220) DYNJ81280A, UDI-DI: 10195327491284(each), 40195327491285(case), Lot Number: 25LME467; 221) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24HBK264; 222) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24DBR594; 223) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24CBI987; 224) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24CBF775; 225) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25FBL492; 226) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25EBG049; 227) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 24IBP146; 228) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 24IBD271; 229) DYNJ85078A, UDI-DI: 10195327532543(each), 40195327532544(case), Lot Number: 24HMA736; 230) DYNJ86194A, UDI-DI: 10195327682293(each), 40195327682294(case), Lot Number: 24DBN706; 231) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 25LMD475; 232) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24IBL260; 233) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24HBV552; 234) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24CBG395; 235) DYNJ87378, UDI-DI: 10198459034787(each), 40198459034788(case), Lot Number: 24HMA738; 236) DYNJ87378, UDI-DI: 10198459034787(each), 40198459034788(case), Lot Number: 24GMG790; 237) DYNJ87378A, UDI-DI: 10198459186394(each), 40198459186395(case), Lot Number: 24KMI285; 238) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25JMI380; 239) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25IMC112; 240) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25IMA065; 241) DYNJ87451, UDI-DI: 10198459040283(each), 40198459040284(case), Lot Number: 24HBH452; 242) DYNJ88498, UDI-DI: 10198459166181(each), 40198459166182(case), Lot Number: 24KMF610; 243) DYNJ88498, UDI-DI: 10198459166181(each), 40198459166182(case), Lot Number: 24KMC641; 244) DYNJ902993F, UDI-DI: 10193489490817(each), 40193489490818(case), Lot Number: 23IMD509; 245) DYNJ902993F, UDI-DI: 10193489490817(each), 40193489490818(case), Lot Number: 23IMA480; 246) DYNJ905866, UDI-DI: 10193489547184(each), 40193489547185(case), Lot Number: 23CBW319; 247) DYNJ906292B, UDI-DI: 10193489877588(each), 40193489877589(case), Lot Number: 24CBI703; 248) DYNJ906292B, UDI-DI: 10193489877588(each), 40193489877589(case), Lot Number: 24BBV224; 249) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21HBN905; 250) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21GBR282; 251) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21GBG669; 252) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25ABP522; 253) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25ABE814; 254) DYNJ911623, UDI-DI: 10198459441097(each), 40198459441098(case), Lot Number: 25HBH612; 255) DYNJT5739, UDI-DI: 10198459499661(each), 40198459499662(case), Lot Number: 25IMF120; 256) PHS393087007C, UDI-DI: 10193489222777(each), 40193489222778(case), Lot Number: 21ADA448
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0520IC; UDI: 04953170308581, 04953170608710; All Lots.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJ0185290G, UDI-DI: 10193489378054(each), 40193489378055(case), Lot Number: 22LBQ336; 2) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24BBN429; 3) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23KBI089; 4) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23HBG596; 5) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23FBL644; 6) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23FBG152; 7) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23EBH550; 8) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23CBQ546; 9) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22NBF780; 10) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22LBC300; 11) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBP453; 12) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBM263; 13) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBF686; 14) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22CBY841; 15) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21KBR457; 16) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21KBA253; 17) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21IBH675; 18) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21GBE802; 19) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21EBE777
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Issue with software algorithm which may lead to overpressure events.
Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21FBA766; 2) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21DBB713; 3) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21CBH955; 4) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABX057; 5) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABK325; 6) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 23CBN841; 7) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22LBK911; 8) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22KBH787; 9) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22HBQ099; 10) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22FBX191; 11) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22FBF305; 12) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22DBR042; 13) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22DBM224; 14) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBM867; 15) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBL555; 16) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABM691; 17) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABD970; 18) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21WBA902; 19) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21JBJ227; 20) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21IBU128; 21) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR277; 22) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR275; 23) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBS122; 24) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBE305; 25) DYNJ85691, UDI-DI: 10195327534141(each), 40195327534142(case), Lot Number: 24ABR853
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M; 10) NEW LONDON MINOR CDS, Model Number: CDS982518M; 11) NEW LONDON MINOR CDS, Model Number: CDS982518N; 12) NEW LONDON MINOR CDS, Model Number: CDS982518O; 13) NEW LONDON MINOR CDS, Model Number: CDS982518P; 14) GENERAL LAPAROSCOPY CDS, Model Number: CDS983311J; 15) LAVH CDS, Model Number: CDS983411G; 16) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244J; 17) ROBOTIC-LF, Model Number: CDS984543C; 18) CYSTO CDS, Model Number: CDS984592G; 19) CYSTO CDS, Model Number: CDS984592I; 20) ROBOTIC, Model Number: CDS985270F; 21) GENERAL LAPAROSCOPY CDS, Model Number: CDS985422I; 22) ROBOTIC CDS, Model Number: CDS985429L; 23) LAP CHOLE CDS, Model Number: CDS985558N; 24) LAP CHOLE CDS, Model Number: CDS985558O; 25) ENDO KIT, Model Number: DYKE1580A; 26) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105; 27) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105A; 28) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105B; 29) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116; 30) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116B; 31) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117A; 32) KIT SURG ONC DIAGNOSTIC LAPARO, Model Number: DYKMBNDL12; 33) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121; 34) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121A; 35) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121B; 36) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121C; 37) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121F; 38) KIT L&D CYSTO SETUP, Model Number: DYKMBNDL135A; 39) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136; 40) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136A; 41) KIT THORACIC STAGING LAPAROTOM, Model Number: DYKMBNDL15; 42) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153A; 43) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153B; 44) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173; 45) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173A; 46) KIT THORACIC HIATAL HERNIA TRA, Model Number: DYKMBNDL175; 47) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176; 48) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176A; 49) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176B; 50) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176C; 51) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184; 52) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184A; 53) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188A; 54) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193; 55) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193A; 56) KIT UROLOGY BUCCAL GRAFT, Model Number: DYKMBNDL206; 57) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; 58) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60; 59) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60A; 60) KIT UROLOGY MINOR, Model Number: DYKMBNDL61A; 61) KIT UROLOGY MINOR, Model Number: DYKMBNDL61B; 62) KIT GEN SURG LAP COLECTOMY, Model Number: DYKMBNDL73; 63) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73A; 64) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73B; 65) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73C; 66) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73D; 67) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74; 68) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74A; 69) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74B; 70) KIT GEN SURG LAP GASTRIC BYPAS,
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBT172; 2) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBD726; 3) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21KBB595; 4) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21IBL031; 5) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21GBS688; 6) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21FBR386; 7) CDS860015V, UDI-DI: 10195327209582(each), 40195327209583(case), Lot Number: 22HBF170; 8) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23LBQ388; 9) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23KBX194; 10) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23JBR469; 11) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23HBT489; 12) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23GBM065; 13) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23FBP597; 14) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25EBQ940; 15) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25DBF532; 16) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24EBA340; 17) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBP400; 18) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBC504; 19) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBQ637; 20) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBH684; 21) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22BBL530; 22) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22ABD367; 23) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21KBI389; 24) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV762; 25) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV761; 26) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21FBC634; 27) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21EBD212; 28) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 23ABM653; 29) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22KBA835; 30) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22JBE511; 31) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 24BBK121; 32) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23KBP519; 33) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23IBO655; 34) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23GBD634; 35) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25LMH226; 36) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25JBA926; 37) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25FBG578; 38) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25DBK311; 39) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24LBS320; 40) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24KBA566; 41) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24HBG876; 42) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24GBQ718; 43) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24DBJ711; 44) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24CBD741; 45) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23ABM631; 46) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22EBC713; 47) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22BBZ407; 48) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21KBE056; 49) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21HBH225; 50) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21FBI691; 51) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBS430; 52) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBA456; 53) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 23ABD137; 54) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 22LBC678; 55) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 24BBO559; 56) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 24ABY635; 57) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23KBK137; 58) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23JBI537; 59) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23IBP894; 60) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23IBN820; 61) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23GBG980; 62) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23EBE898; 63) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23BBM210; 64) CDS983311J, UDI-DI: 10193489424638(each), 40193489424639(case), Lot Number: 24CDA326; 65) CDS983411G, UDI-DI: 10193489353013(each), 40193489353014(case), Lot Number: 21ADB442; 66) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 23CBT375; 67) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 23BBS348; 68) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 23ABB754; 69) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22OBA973; 70) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22OBA586; 71) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22KBB066; 72) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22JBD756; 73) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22GBJ161; 74) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22FBE947; 75) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22FBB129; 76) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22DBR149; 77) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22ABC162; 78) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21VBA278; 79) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21JBA016; 80) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21HBF176; 81) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21FBL036; 82) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21DBT990; 83) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 22AMA823; 84) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21LMC119; 85) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21KME682; 86) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21IMH565; 87) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21HMD025; 88) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21FMD052; 89) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21EMB667; 90) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21CKA290; 91) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 24AMA344; 92) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23LME580; 93) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23KMD724; 94) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23JMH749; 95) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23IMA630; 96) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23HME451; 97) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23GMB958; 98) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23FMI003; 99) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23DMG403; 100) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23DMC548; 101) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23DMC144; 102) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23DMB897; 103) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23CME323; 104) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22LME600; 105) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22JME463; 106) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22JME156; 107) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22IMI474; 108) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22IMF395; 109) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22HMA561; 110) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22GME419; 111) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22EMG101; 112) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22EMD492; 113) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22BMH264; 114) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21LMF036; 115) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21LMB717; 116) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21JME070; 117) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21HMC972; 118) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21FMF224; 119) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21EMA519; 120) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21CKA936; 121) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21AKB236; 122) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24HMJ929; 123) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24HMG227; 124) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24GMD392; 125) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24FMA343; 126) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24EMB806; 127) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24DMF734; 128) CDS985270F, UDI-DI: 10889942864683(each), 40889942864684(case), Lot Number: 21ADB484; 129) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22NBE570; 130) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22GBP860; 131) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22EBJ735; 132) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22DBJ084; 133) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22ABF968; 134) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21KBR555; 135) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21JBM744; 136) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21HBN935; 137) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21HBN934; 138) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21EBI573; 139) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21CBZ732; 140) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21CBQ720; 141) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21BBB192; 142) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21BBA014; 143) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 22OBC139; 144) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 22GBD838; 145) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 22EBV213; 146) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 22ABY343; 147) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 21LBU039; 148) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 21JBF851; 149) CDS985558N, UDI-DI: 10193489487343(each), 40193489487344(case), Lot Number: 21HBJ869; 150) CDS985558N, UDI-DI: 10193489487343(each), 40193489487344(case), Lot Number: 21FBO771; 151) CDS985558N, UDI-DI: 10193489487343(each), 40193489487344(case), Lot Number: 21FBF387; 152) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 23DBH534; 153) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 23DBE098; 154) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 23CBH215; 155) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 23ABF065; 156) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22OBE746; 157) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22JBT595; 158) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22IBT627; 159) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22FBV606; 160) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22EBQ394; 161) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22EBK620; 162) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22EBA491; 163) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22CBG806; 164) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 21LBT009; 165) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 21JBL422; 166) DYKE1580A, UDI-DI: 10193489432237(each), 40193489432238(case), Lot Number: 21DBF753; 167) DYKE1580A, UDI-DI: 10193489432237(each), 40193489432238(case), Lot Number: 21ABX247; 168) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 24BBE022; 169) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 24ABO459; 170) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23KBS983; 171) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23JBY272; 172) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23HBT455; 173) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23HBO182; 174) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23CBP835; 175) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23CBA392; 176) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22LBL912; 177) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22KBF614; 178) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22JBI876; 179) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22IBS852; 180) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22IBG856; 181) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22HBQ095; 182) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22GBT273; 183) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22FBV210; 184) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22FBR125; 185) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21JBU233; 186) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21GBR346; 187) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21FBP719; 188) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21DBF835; 189) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21BBH635; 190) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21BBA025; 191) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21ABI966; 192) DYKMBNDL105A, UDI-DI: 10195327633776(each), 40195327633777(case), Lot Number: 24CBR484; 193) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 25ABO965; 194) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 25ABD849; 195) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24LBS832; 196) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24LBF747; 197) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24JBI870; 198) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24HBD158; 199) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24DBR906; 200) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21CBI082; 201) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21CBF516; 202) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ALA406; 203) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ALA324; 204) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ABU308; 205) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ABS541; 206) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ABP683; 207) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 23CBP082; 208) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 23BBQ048; 209) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 23ABM976; 210) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 22LBH335; 211) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 22JBM224; 212) DYKMBNDL117A, UDI-DI: 10193489882773(each), 40193489882774(case), Lot Number: 22ELA421; 213) DYKMBNDL117A, UDI-DI: 10193489882773(each), 40193489882774(case), Lot Number: 22ALA614; 214) DYKMBNDL117A, UDI-DI: 10193489882773(each), 40193489882774(case), Lot Number: 21ILA049; 215) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25HBV157; 216) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25GBH906; 217) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25EBT272; 218) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25EBM208; 219) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25DBK742; 220) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25BBA443; 221) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25ABG274; 222) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24KBT014; 223) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24JBD656; 224) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24HBG307; 225) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24GBV668; 226) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24EBV298; 227) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24ABX945; 228) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23JBB703; 229) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23IBJ531; 230) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23HBH772; 231) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23GBM663; 232) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23FBQ220; 233) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23BBS803; 234) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22LBM792; 235) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22LBK906; 236) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22IBR709; 237) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22HBT845; 238) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22GBG153; 239) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22EBQ052; 240) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22EBB288; 241) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22DBQ840; 242) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22DBP449; 243) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22DBP086; 244) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22DBP077; 245) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22ABO074; 246) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21LBV341; 247) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21LBT163; 248) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21LBP648; 249) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21LBO672; 250) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21JBQ908; 251) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21IBP754; 252) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21HBN005; 253) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21GBJ359; 254) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21DBJ863; 255) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21DBC546; 256) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21CBE514; 257) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21ABR762; 258) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21ABM150; 259) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21CBV963; 260) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21CBS661; 261) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21CBE524; 262) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21BBG050; 263) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21ABM463; 264) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21ABI969; 265) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22HLA998; 266) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22FLA994; 267) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22ELA175; 268) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22ELA051; 269) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22ELA007; 270) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22DLA673; 271) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22DLA406; 272) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22DLA132; 273) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22CLA524; 274) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22CLA149; 275) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22BLA626; 276) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22ALA028; 277) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21LLA312; 278) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21KLA523; 279) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21JLA652; 280) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21JLA001; 281) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21ILA935; 282) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21HLB016; 283) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21HLA548; 284) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21GLA171; 285) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21FLA210; 286) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21ELA833; 287) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21ELA413; 288) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21ELA387; 289) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21DLA540; 290) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 23CLA551; 291) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 23BLA368; 292) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 22LLA491; 293) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 22KLA012; 294) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 22ILA068; 295) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 24ALA168; 296) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23KLA555; 297) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23JLA993; 298) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23ILA468; 299) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23GLB004; 300) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23FLB006; 301) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23ELA668; 302) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23CLA837; 303) DYKMBNDL121F, UDI-DI: 10198459000713(each), 40198459000714(case), Lot Number: 24FLA948; 304) DYKMBNDL121F, UDI-DI: 10198459000713(each), 40198459000714(case), Lot Number: 24FLA318; 305) DYKMBNDL135A, UDI-DI: 10195327244224(each), 40195327244225(case), Lot Number: 23KBI973; 306) DYKMBNDL135A, UDI-DI: 10195327244224(each), 40195327244225(case), Lot Number: 23KBE452; 307) DYKMBNDL135A, UDI-DI: 10195327244224(each), 40195327244225(case), Lot Number: 22LBO995; 308) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 24ABX941; 309) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 24ABG851; 310) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 23KBF074; 311) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 21BBG515; 312) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 21ABI971; 313) DYKMBNDL136A, UDI-DI: 10198459000720(each), 40198459000721(case), Lot Number: 24DBR914; 314) DYKMBNDL15, UDI-DI: 10193489477580(each), 40193489477581(case), Lot Number: 21BBG088; 315) DYKMBNDL15, UDI-DI: 10193489477580(each), 40193489477581(case), Lot Number: 21ABI974; 316) DYKMBNDL153A, UDI-DI: 10195327240516(each), 40195327240517(case), Lot Number: 22KBJ482; 317) DYKMBNDL153B, UDI-DI: 10195327369057(each), 40195327369058(case), Lot Number: 23FBB469; 318) DYKMBNDL173, UDI-DI: 10193489478327(each), 40193489478328(case), Lot Number: 21BBA252; 319) DYKMBNDL173, UDI-DI: 10193489478327(each), 40193489478328(case), Lot Number: 21ALA522; 320) DYKMBNDL173, UDI-DI: 10193489478327(each), 40193489478328(case), Lot Number: 20LBY935; 321) DYKMBNDL173, UDI-DI: 10193489478327(each), 40193489478328(case), Lot Number: 20LBK822; 322) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 22CLA526; 323) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 22ALA404; 324) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21JLB102; 325) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21HLA932; 326) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21HLA289; 327) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21GLA459; 328) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21FLA151; 329) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21CLA355; 330) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 22HBR219; 331) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 22HBQ097; 332) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21LBJ741; 333) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21JBJ251; 334) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21FBS513; 335) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21DBV240; 336) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21BBG090; 337) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21ABI988; 338) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21VBA119; 339) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21KBU588; 340) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21HBM091; 341) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21BBG047; 342) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21ABI989; 343) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 24ABL746; 344) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23KBA265; 345) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23JBV751; 346) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23JBS636; 347) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23IBT885; 348) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23IBF611; 349) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23EBS911; 350) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23EBM441; 351) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23DBN728; 352) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 22KBU993; 353) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 22JBC617; 354) DYKMBNDL176B, UDI-DI: 10195327633790(each), 40195327633791(case), Lot Number: 24CBR360; 355) DYKMBNDL176C, UDI-DI: 10198459000454(each), 40198459000455(case), Lot Number: 25HBA827; 356) DYKMBNDL176C, UDI-DI: 10198459000454(each), 40198459000455(case), Lot Number: 25EBV419; 357) DYKMBNDL176C, UDI-DI: 10198459000454(each), 40198459000455(case), Lot Number: 25CB
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25HBD027; 2) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25FBD161; 3) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBN454; 4) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBG142; 5) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBE995; 6) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25DBE771; 7) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25CBB549; 8) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBS071; 9) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBB895; 10) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24FBK537; 11) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24CBK339; 12) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24ABH890; 13) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 23KBA331; 14) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 22KBD675
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Issue with software algorithm which may lead to overpressure events.
Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 7) ROBOTIC PACK, Model Number: DYNJ04135B; 8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 10) D&C PACK-LF, Model Number: DYNJ22567G; 11) D&C PACK-LF, Model Number: DYNJ22567J; 12) D AND C, Model Number: DYNJ41272B; 13) D AND C, Model Number: DYNJ41272C; 14) OB PACK, Model Number: DYNJ42884; 15) D&C/GYN PACK, Model Number: DYNJ47713A; 16) PERI GYN PACK, Model Number: DYNJ55377D; 17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 18) D&C PACK, Model Number: DYNJ67214D; 19) D&C PACK, Model Number: DYNJ67214F; 20) D&C PACK, Model Number: DYNJ67214G; 21) D&C PACK, Model Number: DYNJ67214I; 22) LITHOTOMY PACK, Model Number: DYNJ80765C; 23) GYN PACK, Model Number: DYNJ83475; 24) D AND C PACK, Model Number: DYNJ87468; 25) D&C-ASC, Model Number: DYNJ900465C; 26) D&C-ASC, Model Number: DYNJ900465D; 27) D&C-ASC, Model Number: DYNJ900465F; 28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 30) D&C, Model Number: DYNJ906947C; 31) PACK PERI GYN DSMC, Model Number: DYNJT6424
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 2) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21CBD150; 3) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBM332; 4) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBL932; 5) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25GBB847; 6) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21IBS290; 7) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21GBE967; 8) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21FBB105; 9) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21DBC065; 10) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21CBQ508; 11) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22HBE127; 12) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22GBL821; 13) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBM235; 14) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBC878; 15) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP063; 16) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP060; 17) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21KBQ697; 18) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21HBB549; 19) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21FBB101; 20) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21DBE919; 21) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25GBG086; 22) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25EBM426; 23) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25BBI842; 24) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25ABF361; 25) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBH410; 26) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBE008; 27) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24KBD429; 28) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBH005; 29) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23CBK988; 30) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 20XBF598; 31) DYNJ04382J, UDI-DI: 10195327271763(each), 40195327271764(case), Lot Number: 22JMI206; 32) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23LBR468; 33) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23JBL141; 34) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21DBJ206; 35) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABL629; 36) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABK140; 37) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24FBJ094; 38) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23GMF146; 39) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23EME955; 40) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG245; 41) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG044; 42) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22GME486; 43) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22DMD888; 44) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22AME935; 45) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21LMB348; 46) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21IMB245; 47) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21GMF389; 48) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21FMA773; 49) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21DME541; 50) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21BMB150; 51) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21AMA560; 52) DYNJ41272C, UDI-DI: 10195327487409(each), 40195327487400(case), Lot Number: 23IMA347; 53) DYNJ42884, UDI-DI: 10888277011076(each), 40888277011077(case), Lot Number: 23CBJ945; 54) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24GBW285; 55) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24FBB582; 56) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24DBG903; 57) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23IBQ206; 58) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23GBP395; 59) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBV760; 60) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBQ343; 61) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23EBB329; 62) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23DBC104; 63) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23CBB298; 64) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23ABU921; 65) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22KBF536; 66) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22JBM589; 67) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22DBQ586; 68) DYNJ58344, UDI-DI: 10889942841721(each), 40889942841722(case), Lot Number: 21DBG514; 69) DYNJ67214D, UDI-DI: 10195327133320(each), 40195327133321(case), Lot Number: 22JBM637; 70) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23CBS078; 71) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23BBM551; 72) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 22LBT250; 73) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23LBG081; 74) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23GBI555; 75) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24DBB420; 76) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24ABG486; 77) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25LBI656; 78) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25KBT912; 79) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBL938; 80) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBC889; 81) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25GBO543; 82) DYNJ83475, UDI-DI: 10195327268411(each), 40195327268412(case), Lot Number: 23GBA918; 83) DYNJ87468, UDI-DI: 10198459041266(each), 40198459041267(case), Lot Number: 24HBC480; 84) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23FMD008; 85) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DME071; 86) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DMC062; 87) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23AMJ541; 88) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22JMF456; 89) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMC505; 90) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMA128; 91) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22GBP729; 92) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBG597; 93) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBD247; 94) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22BBE872; 95) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21JBW028; 96) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBI550; 97) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBA045; 98) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21HBK281; 99) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21FBL088; 100) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21DBC055; 101) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21ABU698; 102) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24EMG501; 103) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24CME409; 104) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24AMA976; 105) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23KMA629; 106) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23JMD404; 107) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25LMA690; 108) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25IMG392; 109) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25BMF779; 110) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 24IMI010; 111) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24LBF949; 112) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24KBT705; 113) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24JBH803; 114) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24HBU990; 115) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24GBW026; 116) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24EBJ699; 117) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24DBI465; 118) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24CBT820; 119) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBG800; 120) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBC557; 121) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24ABG736; 122) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23LBP758; 123) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBN910; 124) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBH145; 125) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23IBA468; 126) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23HBI647; 127) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25LMF580; 128) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25JBO532; 129) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25IBD839; 130) DYNJ906947C, UDI-DI: 10195327569006(each), 40195327569007(case), Lot Number: 24BBL769; 131) DYNJT6424, UDI-DI: 10198459553622(each), 40198459553623(case), Lot Number: 25KMI469
Feb 25, 2026
View details →Wilson-cook medical inc.
High PriorityActive
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
RPN: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 Work Order Number / RPN W4954835 / TESLA-B2535-260 W4954836 / TESLA-B2535-260 W4957208 / TESLA-B2535-260 W4958992 / TESLA-B2535-260 W4960895 / TESLA-B2535-260 W4960896 / TESLA-B2535-260 W4961670 / TESLA-B2535-260 W4965708 / TESLA-B2535-260 W4966040 / TESLA-B2535-260 W4966803 / TESLA-B2535-260 W4967866 / TESLA-B2535-260 W4968515 / TESLA-B2535-260 W4968867 / TESLA-B2535-260 W4969292 / TESLA-B2535-260 W4969674 / TESLA-B2535-260 W4969687 / TESLA-B2535-260 W4970315 / TESLA-B2535-260 W4970662 / TESLA-B2535-260 W4971561 / TESLA-B2535-260 W4972693 / TESLA-B2535-260 W4973085 / TESLA-B2535-260 W4974435 / TESLA-B2535-260 W4974588 / TESLA-B2535-260 W4975407 / TESLA-B2535-260 W4975688 / TESLA-B2535-260 W4977514 / TESLA-B2535-260 W4977824 / TESLA-B2535-260 W4979182 / TESLA-B2535-260 W4979183 / TESLA-B2535-260 W4979665 / TESLA-B2535-260 W4982425 / TESLA-B2535-260 W4982436 / TESLA-B2535-260 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 Work Order Number / RPN: W4962311 / TESLA-B2535-450 W4966039 / TESLA-B2535-450 W4968222 / TESLA-B2535-450 W4969306 / TESLA-B2535-450 W4970322 / TESLA-B2535-450 W4971499 / TESLA-B2535-450 W4975687 / TESLA-B2535-450 W4977254 / TESLA-B2535-450 W4982013 / TESLA-B2535-450
Feb 25, 2026
View details →Integra lifesciences corp. (neurosciences)
High PriorityActive
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Model Number: CVS405406; UDI-DI: 00050428452547; Lot Numbers: 2428, 2446, 2509, 2514.
Feb 25, 2026
View details →Auris health, inc
High PriorityActive
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
Software versions: 2.2.2, 2.2.3, 2.2.4, 2.2.5, and 4.1.1. UDI-DI: 10810068810803, 10810068810988. Serial Numbers: 110024, 120088, 120057, 120046, 120058, 120015, 120160, 120068, 120081, 120056, 110028, 120128, 120017, 120089, 120075, 110016, 120031, 120169, 120113, 120168, 120055, 120014, 120060, 120174, 120195, 120026, 110038, 120124, 120194, 110027, 110035, 120123, 120091, 120007, 110022, 120006, 120152, 120004, 120120, 120041, 120106, 110034, 120126, 120082, 120151, 120051, 120020, 120153, 120193, 120170, 120108, 120037, 120074, 120199, 120130, 120095, 110026, 120096, 120009, 120111, 120022, 120054, 120163, 110045, 120027, 110039, 120090, 120141, 120072, 120155, 110049, 120143, 110047, 120125, 120052, 110052, 120100, 120050, 120098, 120045, 120131, 110020, 110030, 110032, 110021, 120013, 120105, 120136, 120192, 110017, 120029, 120139, 110031, 120137, 120053, 110029, 120028, 120034, 120085, 120019, 120049, 120209, 120144, 120161, 120001, 110033, 120145, 120127, 110046, 110043, 120011, 120070, 120076, 120134, 120117, 110025, 120077, 120149, 120191, 120102, 120002, 120156, 120010, 120171, 120003, 120023, 120146, 120188, 120043, 120071, 120042, 120196, 110051, 120065, 120172, 120116, 120150, 120066, 120166, 120033, 110013, 120079, 120008, 120086, 120032, 120073, 1806P1, 120197, 120080, 120078, 14, 120012, 110041, 120084, 120219, 110036, 120181, 120083, 120067, 120021, 120216, 120217, 120218, 120069, 120204, 120207, 120215, 120237, 120208, 120213, 120164, 120132, 120182
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25LBC732; 2) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25FBN781; 3) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25DBK346; 4) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24IBD021; 5) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24DBK171; 6) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24BBV821; 7) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23HBP415; 8) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23EBC552; 9) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23CBE825; 10) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22LBR618; 11) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22KBA245; 12) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22EBK467; 13) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22ABE640; 14) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21JBF397; 15) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBE395; 16) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBB933; 17) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21CBV232
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0520FCS; UDI: 04953170383571, 0495317083595, 04953170383588; All Lots.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
1) DYNDTB0529, UDI-DI: 10197344105663(each), 20197344105660(case), Lot Number: All Lot Numbers; 2) DYNDTB1029, UDI-DI: 10197344076956(each), 20197344076953(case), Lot Number: All Lot Numbers; 3) DYNDTB1516, UDI-DI: 10197344105687(each), 20197344105684(case), Lot Number: All Lot Numbers; 4) DYNDTB1530, UDI-DI: 10197344105694(each), 20197344105691(case), Lot Number: All Lot Numbers; 5) DYNDTB1539, UDI-DI: 10197344008254(each), 20197344008251(case), Lot Number: All Lot Numbers; 6) DYNDTB1545, UDI-DI: 10197344098644(each), 20197344098641(case), Lot Number: All Lot Numbers; 7) DYNDTB2045, UDI-DI: 10197344077007(each), 20197344077004(case), Lot Number: All Lot Numbers; 8) DYNDTB0512, UDI-DI: 10197344105656(each), 20197344105653(case), Lot Number: All Lot Numbers; 9) DYNDTB0555, UDI-DI: 10197344105670(each), 20197344105677(case), Lot Number: All Lot Numbers; 10) DYNDTB1022, UDI-DI: 10197344076949(each), 20197344076946(case), Lot Number: All Lot Numbers; 11) DYNDTB1512, UDI-DI: 10197344098613(each), 20197344098610(case), Lot Number: All Lot Numbers; 12) DYNDTB1529, UDI-DI: 10197344098620(each), 20197344098627(case), Lot Number: All Lot Numbers; 13) DYNDTB1537, UDI-DI: 10197344008247(each), 20197344008244(case), Lot Number: All Lot Numbers; 14) DYNDTB1540, UDI-DI: 10197344098637(each), 20197344098634(case), Lot Number: All Lot Numbers; 15) DYNDTB2029, UDI-DI: 10197344076994(each), 20197344076991(case), Lot Number: All Lot Numbers; 16) DYNDTB5077, UDI-DI: 10197344098651(each), 20197344098658(case), Lot Number: All Lot Numbers; 17) DYNDTB1045, UDI-DI: 10197344076963(each), 20197344076960(case), Lot Number: All Lot Numbers; 18) DYNDTB1545D, UDI-DI: 10197344105700(each), 20197344105707(case), Lot Number: All Lot Numbers; 19) DYNDTB2524, UDI-DI: 10197344105717(each), 20197344105714(case), Lot Number: All Lot Numbers; 20) DYNDTB1012, UDI-DI: 10197344076932(each), 20197344076939(case), Lot Number: All Lot Numbers; 21) DYNDTB2012, UDI-DI: 10197344076970(each), 20197344076977(case), Lot Number: All Lot Numbers; 22) DYNDTB2022, UDI-DI: 10197344076987(each), 20197344076984(case), Lot Number: All Lot Numbers; 23) DYNDTB5081, UDI-DI: 10197344098668(each), 20197344098665(case), Lot Number: All Lot Numbers
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DM1035, UDI-DI: 10193489442755(each), 40193489442756(case), Lot Number: 21BBN221; 2) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBN333; 3) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBF510; 4) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22EBL039; 5) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22CBU342; 6) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21JBJ253; 7) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21IBJ337; 8) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21DBD662; 9) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABO838; 10) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABJ003
Feb 25, 2026
View details →Olympus corporation of the americas
High PriorityActive
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Model No. TB-0545FCS; UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519; All Lots.
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNJ63118A, UDI-DI: 10195327644291(each), 40195327644292(case), Lot Number: 25ABV005
Feb 25, 2026
View details →Integra lifesciences corp. (neurosciences)
High PriorityActive
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
Potential packaging failures, which could lead to a breach in the sterile barrier.
1. Model Number: 31805; UDI-DI: 10381780486978; Serial numbers: 2405, 2406, 2407, 2408, 2409, 2410, 2418, 2419, 2421, 2422, 2432, 2433, 2513, 2514, 2515. 2. Model Numbers: 31815; UDI-DI: 10381780486886; Lot Numbers: 2407, 2408, 2419, 2425, 2429, 2430, 2442, 2443, 2444, 2445, 2446, 2449, 2450, 2502, 2513, 2515, 2516.
Feb 25, 2026
View details →Kaz usa, inc., a helen of troy company
Low PriorityActive
Vicks Sinus Steam Inhaler (Vih200cv1) Recall
Recalls and safety alerts
Feb 25, 2026
View details →Immunotech a.s.
High PriorityActive
Estrone RIA, REF: DSL8700
The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 6) PICC CATHETER INSERTION TRAY, Model Number: CVI4300
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21BBB580; 2) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABJ543; 3) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABC197; 4) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLB021; 5) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLA694; 6) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22FLA745; 7) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ELA008; 8) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22DLA407; 9) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22CLA448; 10) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22BLA721; 11) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ALA593; 12) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21JLA910; 13) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ILA163; 14) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21HLA740; 15) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21GLA677; 16) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21FLA214; 17) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ELA080; 18) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21DLA326; 19) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA621; 20) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391Z; 21) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391; 22) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21DLA343; 23) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA631; 24) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA056; 25) LC295, UDI-DI: 10653160322702(each), 00653160322705(case), Lot Number: 2025110490; 26) DYKM1977C, UDI-DI: 10653160381105(each), 00653160381108(case), Lot Number: 2024110190; 27) CVI4300, UDI-DI: 10653160294313(each), 00653160294316(case), Lot Number: 2020120950
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYNDM1031A, UDI-DI: 10884389555897(each), 40884389555898(case), Lot Number: 23EBM150
Feb 25, 2026
View details →Bard peripheral vascular inc
High PriorityActive
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Due to damage to outer tray that can potentially compromise the sterile barrier
Product Name: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Catalog Number: 600060 UDI code: (01)00801741051692(17)300728(10)HUKV0547 Lot Number: HUKV0547 Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Catalog Number: 600100 UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray (Short External Length) with SureCuff Tissue Ingrowth Cuff Catalog Number: 600120 UDI code: (01)00801741051715(17)300628(10)HUKU0274 Lot Number: HUKU0274 Name: Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Catalog Number: 600310 UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310 Name: Hickman 12 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Catalog Number: 600350 UDI code: (01)00801741051777(17)300428(10)HUKR1359 (01)00801741051777(17)300428(10)HUKS0811 (01)00801741051777(17)300628(10)HUKU0316 Lot Number: HUKR1359 HUKS0811 HUKU0316 Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 600520 UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 (01)00801741051807(17)270528(10)HUKU0305 (01)00801741051807(17)270528(10)HUKU0327 (01)00801741051807(17)270528(10)HUKU0338 (01)00801741051807(17)270528(10)HUKU0353 (01)00801741051807(17)270528(10)HUKW0164 (01)00801741051807(17)280328(10)HUKW1278 (01)00801741051807(17)280328(10)HUKW1285 Lot Number: HUKS1468 HUKU0246 HUKU0278 HUKU0289 HUKU0305 HUKU0327 HUKU0338 HUKU0353 HUKW0164 HUKW1278 HUKW1285 Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 600540 UDI code: (01)00801741051821(17)290428(10)HUKR0064 (01)00801741051821(17)290628(10)HUKR0065 (01)00801741051821(17)290628(10)HUKR0067 (01)00801741051821(17)300128(10)HUKU0252 (01)00801741051821(17)300128(10)HUKU0270 (01)00801741051821(17)300128(10)HUKU0279 (01)00801741051821(17)300128(10)HUKU0308 (01)00801741051821(17)300128(10)HUKU0334 (01)00801741051821(17)300328(10)HUKV0359 (01)00801741051821(17)300328(10)HUKV0550 (01)00801741051821(17)300328(10)HUKV0560 (01)00801741051821(17)300328(10)HUKW0156 (01)00801741051821(17)300328(10)HUKW0159 Lot Number: HUKR0064 HUKR0065 HUKR0067 HUKU0252 HUKU0270 HUKU0279 HUKU0308 HUKU0334 HUKV0359 HUKV0550 HUKV0560 HUKW0156 HUKW0159 Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 600560 UDI code: (01)00801741051845(17)290828(10)HUKS0776 (01)00801741051845(17)290828(10)HUKS0816 (01)00801741051845(17)290928(10)HUKS1220 (01)00801741051845(17)290928(10)HUKU0302 (01)00801741051845(17)290928(10)HUKU0311 (01)00801741051845(17)300128(10)HUKU0345 (01)00801741051845(17)300128(10)HUKU0350 (01)00801741051845(17)300128(10)HUKV0376 (01)00801741051845(17)300128(10)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0376 HUKV0555 Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 600570 UDI code: (01)00801741051869(17)290628(10)HUKR1342 (01)00801741051869(17)290628(10)HUKR1344 (01)00801741051869(17)300128(10)HUKR1346 (01)00801741051869(17)290628(10)HUKR1347 (01)00801741051869(17)300128(10)HUKR1348 (01)00801741051869(17)300128(10)HUKR1356 (01)00801741051869(17)290628(10)HUKR1363 (01)00801741051869(17)290628(10)HUKR1367 (01)00801741051869(17)300128(10)HUKR1368 (01)00801741051869(17)300128(10)HUKS0774 (01)00801741051869(17)300128(10)HUKU0238 (01)00801741051869(17)300128(10)HUKU0242 (01)00801741051869(17)300128(10)HUKU0247 (01)00801741051869(17)300128(10)HUKU0253 (01)00801741051869(17)300128(10)HUKU0254 (01)00801741051869(17)300128(10)HUKU0266 (01)00801741051869(17)300128(10)HUKU0280 (01)00801741051869(17)300128(10)HUKU0283 (01)00801741051869(17)300128(10)HUKU0284 (01)00801741051869(17)300128(10)HUKU0290 (01)00801741051869(17)300128(10)HUKU0293 (01)00801741051869(17)300128(10)HUKU0294 (01)00801741051869(17)300128(10)HUKU0298 (01)00801741051869(17)300128(10)HUKU0312 (01)00801741051869(17)300128(10)HUKU0339 (01)00801741051869(17)300328(10)HUKU0340 (01)00801741051869(17)300128(10)HUKU0344 (01)00801741051869(17)300128(10)HUKU0354 (01)00801741051869(17)300328(10)HUKV0549 (01)00801741051869(17)300328(10)HUKV0569 (01)00801741051869(17)300328(10)HUKV0576 (01)00801741051869(17)300328(10)HUKV0581 (01)00801741051869(17)300328(10)HUKW0148 Lot Number: HUKR1342 HUKR1344 HUKR1346 HUKR1347 HUKR1348 HUKR1356 HUKR1363 HUKR1367 HUKR1368 HUKS0774 HUKU0238 HUKU0242 HUKU0247 HUKU0253 HUKU0254 HUKU0266 HUKU0280 HUKU0283 HUKU0284 HUKU0290 HUKU0293 HUKU0294 HUKU0298 HUKU0312 HUKU0339 HUKU0340 HUKU0344 HUKU0354 HUKV0549 HUKV0569 HUKV0576 HUKV0581 HUKW0148 Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 600620 UDI code: (01)00801741051913(17)291028(10)HUJY0302 (01)00801741051913(17)291028(10)HUJY1095 (01)00801741051913(17)291128(10)HUJZ1332 (01)00801741051913(17)291128(10)HUJZ1336 (01)00801741051913(17)291128(10)HUJZ1339 (01)00801741051913(17)291128(10)HUJZ1340 (01)00801741051913(17)300328(10)HUKR1349 (01)00801741051913(17)300328(10)HUKR1364 (01)00801741051913(17)300428(10)HUKS0784 (01)00801741051913(17)300428(10)HUKS0806 (01)00801741051913(17)300428(10)HUKS1217 (01)00801741051913(17)230428(10)HUKS1218 (01)00801741051913(17)300628(10)HUKU0259 (01)00801741051913(17)300628(10)HUKU0351 (01)00801741051913(17)300728(10)HUKV0349 (01)00801741051913(17)300728(10)HUKV0567 (01)00801741051913(17)300828(10)HUKW0534 Lot Number: HUJY0302 HUJY1095 HUJZ1332 HUJZ1336 HUJZ1339 HUJZ1340 HUKR1349 HUKR1364 HUKS0784 HUKS0806 HUKS1217 HUKS1218 HUKU0259 HUKU0351 HUKV0349 HUKV0567 HUKW0534 Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 600650 UDI code: (01)00801741051975(17)300228(10)HUKQ0535 (01)00801741051975(17)300428(10)HUKS1474 (01)00801741051975(17)300428(10)HUKS1483 (01)00801741051975(17)300628(10)HUKU0313 (01)00801741051975(17)300628(10)HUKU0317 (01)00801741051975(17)300628(10)HUKU0328 (01)00801741051975(17)300728(10)HUKV0354 (01)00801741051975(17)300728(10)HUKV0371 (01)00801741051975(17)300828(10)HUKW0171 (01)00801741051975(17)300828(10)HUKW1283 Lot Number: HUKQ0535 HUKS1474 HUKS1483 HUKU0313 HUKU0317 HUKU0328 HUKV0354 HUKV0371 HUKW0171 HUKW1283 Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 606560 UDI code: (01)00801741052019(17)290828(10)HUKR1370 (01)00801741052019(17)290928(10)HUKS1219 (01)00801741052019(17)300128(10)HUKU0255 (01)00801741052019(17)290928(10)HUKU0324 (01)00801741052019(17)300128(10)HUKV0578 (01)00801741052019(17)300128(10)HUKW0172 (01)00801741052019(17)300128(10)HUKW1315 Lot Number: HUKR1370 HUKS1219 HUKU0255 HUKU0324 HUKV0578 HUKW0172 HUKW1315 Name:Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Catalog Number: 0600100CE UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Name:Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Catalog Number: 0600310CE UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310 Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 0600520CE UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 (01)00801741051807(17)270528(10)HUKU0305 (01)00801741051807(17)270528(10)HUKU0338 (01)00801741051807(17)270528(10)HUKU0353 (01)00801741051807(17)270528(10)HUKW0164 (01)00801741051807(17)280328(10)HUKW1278 (01)00801741051807(17)280328(10)HUKW1285 Lot Number: HUKS1468 HUKU0246 HUKU0278 HUKU0289 HUKU0305 HUKU0338 HUKU0353 HUKW0164 HUKW1278 HUKW1285 Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 0600540CE UDI code: (01)00801741051821(17)290428(10)HUKR0064 (01)00801741051821(17)290628(10)HUKR0065 (01)00801741051821(17)290628(10)HUKR0067 (01)00801741051821(17)300128(10)HUKU0252 (01)00801741051821(17)300128(10)HUKU0270 (01)00801741051821(17)300128(10)HUKU0279 (01)00801741051821(17)300128(10)HUKU0308 (01)00801741051821(17)300128(10)HUKU0334 (01)00801741051821(17)300328(10)HUKV0359 (01)00801741051821(17)300328(10)HUKV0550 (01)00801741051821(17)300328(10)HUKW0156 (01)00801741051821(17)300328(10)HUKW0159 Lot Number: HUKR0064 HUKR0065 HUKR0067 HUKU0252 HUKU0270 HUKU0279 HUKU0308 HUKU0334 HUKV0359 HUKV0550 HUKW0156 HUKW0159 Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 0600560CE UDI code: (01)00801741051845(17)290828(10)HUKS0776 (01)00801741051845(17)290828(10)HUKS0816 (01)00801741051845(17)290928(10)HUKS1220 (01)00801741051845(17)290928(10)HUKU0302 (01)00801741051845(17)290928(10)HUKU0311 (01)00801741051845(17)300128(10)HUKU0345 (01)00801741051845(17)300128(10)HUKU0350 (01)00801741051845(17)300128(10)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0555 Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 0600570CE UDI code: (01)00801741051869(17)290628(10)HUKR1342 (01)00801741051869(17)290628(10)HUKR1344 (01)00801741051869(17)300128(10)HUKR1346 (01)00801741051869(17)290628(10)HUKR1347 (01)00801741051869(17)300128(10)HUKR1348 (01)00801741051869(17)300128(10)HUKR1356 (01)00801741051869(17)290628(10)HUKR1363 (01)00801741051869(17)290628(10)HUKR1367 (01)00801741051869(17)300128(10)HUKR1368 (01)00801741051869(17)300128(10)HUKS0774 (01)00801741051869(17)300128(10)HUKU0238 (01)00801741051869(17)300128(10)HUKU0242 (01)00801741051869(17)300128(10)HUKU0247 (01)00801741051869(17)300128(10)HUKU0253 (01)00801741051869(17)300128(10)HUKU0254 (01)00801741051869(17)300128(10)HUKU0266 (01)00801741051869(17)300128(10)HUKU0280 (01)00801741051869(17)300128(10)HUKU0283 (01)00801741051869(17)300128(10)HUKU0284 (01)00801741051869(17)300128(10)HUKU0290 (01)00801741051869(17)300128(10)HUKU0293 (01)00801741051869(17)300128(10)HUKU0294 (01)00801741051869(17)300128(10)HUKU0298 (01)00801741051869(17)300128(10)HUKU0312 (01)00801741051869(17)300128(10)HUKU0339 (01)00801741051869(17)300328(10)HUKU0340 (01)00801741051869(17)300128(10)HUKU0344 (01)00801741051869(17)300128(10)HUKU0354 (01)00801741051869(17)300328(10)HUKV0549 (01)00801741051869(17)300328(10)HUKV0576 (01)00801741051869(17)300328(10)HUKW0148 Lot Number: HUKR1342 HUKR1344 HUKR1346 HUKR1347 HUKR1348 HUKR1356 HUKR1363 HUKR1367 HUKR1368 HUKS0774 HUKU0238 HUKU0242 HUKU0247 HUKU0253 HUKU0254 HUKU0266 HUKU0280 HUKU0283 HUKU0284 HUKU0290 HUKU0293 HUKU0294 HUKU0298 HUKU0312 HUKU0339 HUKU0340 HUKU0344 HUKU0354 HUKV0549 HUKV0576 HUKW0148 Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 0600620CE UDI code: (01)00801741051913(17)291028(10)HUJY0302 (01)00801741051913(17)291028(10)HUJY1095 (01)00801741051913(17)291128(10)HUJZ1332 (01)00801741051913(17)291128(10)HUJZ1336 (01)00801741051913(17)291128(10)HUJZ1339 (01)00801741051913(17)291128(10)HUJZ1340 (01)00801741051913(17)300328(10)HUKR1349 (01)00801741051913(17)300328(10)HUKR1364 (01)00801741051913(17)300428(10)HUKS0784 (01)00801741051913(17)300428(10)HUKS0806 (01)00801741051913(17)300428(10)HUKS1217 (01)00801741051913(17)230428(10)HUKS1218 (01)00801741051913(17)300628(10)HUKU0259 (01)00801741051913(17)300628(10)HUKU0351 (01)00801741051913(17)300728(10)HUKV0349 (01)00801741051913(17)300728(10)HUKV0567 (01)00801741051913(17)300828(10)HUKW0534 Lot Number: HUJY0302 HUJY1095 HUJZ1332 HUJZ1336 HUJZ1339 HUJZ1340 HUKR1349 HUKR1364 HUKS0784 HUKS0806 HUKS1217 HUKS1218 HUKU0259 HUKU0351 HUKV0349 HUKV0567 HUKW0534 Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 0600650CE UDI code: (01)00801741051975(17)300228(10)HUKQ0535 (01)00801741051975(17)300428(10)HUKS1474 (01)00801741051975(17)300428(10)HUKS1483 (01)00801741051975(17)300628(10)HUKU0313 (01)00801741051975(17)300628(10)HUKU0317 (01)00801741051975(17)300628(10)HUKU0328 (01)00801741051975(17)300728(10)HUKV0354 (01)00801741051975(17)300728(10)HUKV0371 (01)00801741051975(17)300828(10)HUKW0171 (01)00801741051975(17)300828(10)HUKW1283 Lot Number: HUKQ0535 HUKS1474 HUKS1483 HUKU0313 HUKU0317 HUKU0328 HUKV0354 HUKV0371 HUKW0171 HUKW1283 Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Catalog Number: 0606560CE UDI code: (01)00801741052019(17)290828(10)HUKR1370 (01)00801741052019(17)290928(10)HUKS1219 (01)00801741052019(17)300128(10)HUKU0255 (01)00801741052019(17)290928(10)HUKU0324 (01)00801741052019(17)300128(10)HUKV0578 (01)00801741052019(17)300128(10)HUKW0172 (01)00801741052019(17)300128(10)HUKW1315 Lot Number: HUKR1370 HUKS1219 HUKU0255 HUKU0324 HUKV0578 HUKW0172 HUKW1315
Feb 25, 2026
View details →Medline industries, lp
High PriorityActive
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
1) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 23ABK216; 2) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBU924; 3) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBQ267; 4) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBL439; 5) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBC364; 6) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23ABU170; 7) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBM302; 8) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBK913; 9) DYNDH1143C, UDI-DI: 10193489193336(each), 40193489193337(case), Lot Number: 22GBZ268; 10) DYNDH1873, UDI-DI: 10195327486464(each), 40195327486465(case), Lot Number: 23KBK476; 11) DYNDH1934, UDI-DI: 10195327519728(each), 40195327519729(case), Lot Number: 24FMF173; 12) DYNJ17489I, UDI-DI: 10195327224783(each), 40195327224784(case), Lot Number: 23CBL337; 13) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24GBD309; 14) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24EBQ366; 15) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24DBK656; 16) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24ABL751; 17) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23KBD033; 18) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23HBR688; 19) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23GBI270; 20) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23DMD933; 21) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23AMC919; 22) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22EMD675; 23) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22BMH767; 24) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 21JMC430; 25) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LMF497; 26) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LME482; 27) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25JBA908; 28) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25IBA545; 29) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25HBK043; 30) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25EBA588; 31) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 24IBT900; 32) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23EBQ760; 33) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 22LBH614; 34) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22LMF004; 35) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22JMG410
Feb 25, 2026
View details →Abiomed inc.
Low PriorityActive
Automated Impella Controller Recall
Recalls and safety alerts
Feb 25, 2026
View details →Olympus winter & ibe gmbh
Low PriorityActive
Celon ProBreath and Celon ProSleep Applicators Recall
Recalls and safety alerts
Feb 20, 2026
View details →Bd switzerland sarl
Low PriorityActive
BD Alaris™ Syringe Pumps Recall
Recalls and safety alerts
Feb 20, 2026
View details →Merit medical systems inc.
Low PriorityActive
BioFlo Dialysis Catheter With Endexo Technology Recall
Recalls and safety alerts
Feb 19, 2026
View details →Auris health incorporated
Low PriorityActive
Monarch Platform Recall
Recalls and safety alerts
Feb 19, 2026
View details →Fda
Low PriorityActive
Teva-Indomethacin: Out of specification Recall
Recalls and safety alerts
Feb 19, 2026
View details →Covidien llc
Low PriorityActive
Bipolar Hugo RAS Systems Recall
Recalls and safety alerts
Feb 19, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
1) Kit SKU DYNDH1576, UDI/DI 10193489437041, Lot Number 25EBP737; 2) Kit SKU RWM-DC57KC, UDI/DI 10889942582013, Lot Number 25EBE082.
Feb 18, 2026
View details →Bd kiestra b.v.
Low PriorityActive
Kiestra ReadA Recall
Recalls and safety alerts
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
81105RH UDI-DI 10197344133253 Lot EP250618; 81172RH UDI-DI 10197344133284 Lot EP250618; 81202RH UDI-DI 10197344133307 Lot EP250618; 81483RH UDI-DI 10197344133444 Lot EP250618; 81102RH UDI-DI (case) 20197344133236¿ (ea) 10197344133239 Lot EP250618; 81104RH UDI-DI 10197344133246 Lot EP250618; 81174RH UDI-DI 10197344133291 Lot EP250618; 81531RH UDI-DI 10197344133512 Lot EP250618; 81532RH UDI-DI 10197344133529 Lot EP250618; 81107RH UDI-DI 10197344133260 Lot EP250618; 81402RH UDI-DI 10197344133352 Lot EP250618; 81404RH UDI-DI 10197344133376 Lot EP250618; 81405RH UDI-DI 10197344133383 Lot EP250618; 81474RH UDI-DI 10197344133437 Lot EP250618; 81473RH UDI-DI 10197344133420 Lot EP250618
Feb 18, 2026
View details →Surepulse medical ltd
High PriorityActive
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
DI Number: 05060550650020/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
Feb 18, 2026
View details →Elekta, inc.
High PriorityActive
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)
Feb 18, 2026
View details →Surepulse medical ltd
High PriorityActive
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
DI Number: 05060550650037/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
Feb 18, 2026
View details →Laerdal medical corporation
High PriorityActive
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; UDI-DI: 07045432088519; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; UDI-DI: 07045432088533; 3) LCSU 4, RTCA; Catalog Number: 881152; UDI-DI: 07045432067132;
Feb 18, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); UDI-DIs: (1)884838085268, (2)884838099258, (3)884838116771, (4)N/A; Serial Numbers: All;
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
10135910RH UDI-DI 10197344026500 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905; 10135936RH UDI-DI 10197344026517 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905
Feb 18, 2026
View details →Fda
Low PriorityActive
CEFAZOLIN FOR INJECTION : Vials may be underfilled... Recall
Recalls and safety alerts
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
401582RH UDI-DI (case) 20888277407517¿ (ea) 10888277407510 Lots EP250618 EP250630; 401940RH UDI-DI 10888277407480 Lot EP250618; 401904RH UDI-DI (case) 20888277407609¿ (ea) 10888277407602 Lots EP250618 EP250630; 401914RH UDI-DI (case) 20888277407524¿ (ea) 10888277407527 Lot EP250618; 401932RH UDI-DI (case) 20888277407678¿ (ea) 10888277407671 Lots EP250618 EP250630; 401652RH UDI-DI 10888277407572 Lots EP250618 EP250630
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH;
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
BD710DF282CRH UDI-DI 10197344044023 Lots EP250429 EP250808; BD710DF282RRH UDI-DI 10197344044030 Lots EP250429 EP250808; BD710FJ282RRH UDI-DI 10197344044054 Lots EP250429 EP250808; BD710FJ282CRH UDI-DI (case) 40197344044048 (ea) 10197344044047 Lots EP250429 EP250808
Feb 18, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
System Model Numbers: (1)722078, (2)722223, (3)722233; UDI-DIs: (1)884838085251, (2)884838099241, (3)884838116764; Serial Numbers: All;
Feb 18, 2026
View details →Philips north america llc
High PriorityActive
Brilliance iCT; Product Code (REF): 728306;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Product Code (REF): 728306; UDI-DI: 00884838059474; Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126, 87127, 87128, 87129, 87130, 87135, 87143, 87148, 87152, 87153, 87157, 87160, 87162, 87167, 87173, 87174, 87176, 87181, 87197, 87198, 87199, 87200 , 87202, 87203, 87204, 87205, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213 , 87214, 87215, 87216, 87217, 87218, 87219, 87220, 87221;
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Feb 18, 2026
View details →Philips north america llc
High PriorityActive
Spectral CT; Product Code (REF): 728333;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Product Code (REF): 728333; UDI-DI: 00884838101111; Serial Numbers: 10055, 10075, 10086, 10096, 10106, 10116, 10126, 10136, 10146, 10156, 10166, 10176, 10186, 10196, 10206, 10217, 10227, 10237, 10247, 10257, 10267, 10277, 10289, 10302, 10314, 12009, 12019, 12029, 396013, 10056, 10076, 10087, 10097, 10107, 10117, 10127, 10137, 10147, 10157, 10167, 10177, 10187, 10197, 10207, 10218, 10228, 10238, 10248, 10258, 10268, 10278, 10290, 10303, 12000, 12010, 12020, 12030, 398003, 10057, 10077, 10088, 10098, 10108, 10118, 10128, 10138, 10148, 10158, 10168, 10178, 10188, 10198, 10208, 10219, 10229, 10239, 10249, 10259, 10269, 10279, 10291, 10304, 12001, 12011, 12021, 12031, 398004, 10058, 10078, 10089, 10099, 10109, 10119, 10129, 10139, 10149, 10159, 10169, 10179, 10189, 10199, 10209, 10220, 10230, 10240, 10250, 10260, 10270, 10280, 10292, 10305, 12002, 12012, 12022, 396005, 10059, 10079, 10090, 10100, 10110, 10120, 10130, 10140, 10150, 10160, 10170, 10180, 10190, 10200, 10210, 10221, 10231, 10241, 10251, 10261, 10271, 10281, 10293, 10306, 12003, 12013, 12023, 396006, 10060, 10080, 10091, 10101, 10111, 10121, 10131, 10141, 10151, 10161, 10171, 10181, 10191, 10201, 10211, 10222, 10232, 10242, 10252, 10262, 10272, 10284, 10294, 10307, 12004, 12014, 12024, 396008, 10061, 10081, 10092, 10102, 10112, 10122, 10132, 10142, 10152, 10162, 10172, 10182, 10192, 10202, 10212, 10223, 10233, 10243, 10253, 10263, 10273, 10285, 10298, 10308, 12005, 12015, 12025, 396009, 10062, 10082, 10093, 10103, 10113, 10123, 10133, 10143, 10153, 10163, 10173, 10183, 10193, 10203, 10213, 10224, 10234, 10244, 10254, 10264, 10274, 10286, 10299, 10310, 12006, 12016, 12026, 396010, 10070, 10083, 10094, 10104, 10114, 10124, 10134, 10144, 10154, 10164, 10174, 10184, 10194, 10204, 10214, 10225, 10235, 10245, 10255, 10265, 10275, 10287, 10300, 10311, 12007, 12017, 12027, 396011, 10074, 10085, 10095, 10105, 10115, 10125, 10135, 10145, 10155, 10165, 10175, 10185, 10195, 10205, 10215, 10226, 10236, 10246, 10256, 10266, 10276, 10288, 10301, 10312, 12008, 12018, 12028, 396012,
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
1) Kit SKU DT22010B, UDI/DI 10653160351092, Lot number 25EBC888; 2) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBO566; 3) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBD964; 4) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBN178; 5) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBL624; 6) Kit SKU DYNDC2208C, UDI/DI 10889942815333, Lot number 25EBC706; 7) Kit SKU DYNDC3107, UDI/DI 10193489917628, Lot number 25EBN742; 8) Kit SKU DYNDH1029C, UDI/DI 10889942816453, Lot number 25EBC778; 9) Kit SKU UVT1250, UDI/DI 10653160995340, Lot number 25EBO757; 10) Kit SKU UVT835, UDI/DI 10653160289180, Lot number 25FMI300; 11) Kit SKU VAR101HVAA, UDI/DI 10193489388145, Lot number 25EBE079.
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
UDI/DI 10195327379292, Lot Number 25EBJ785
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
1) Kit SKU DT22710, Lot Numbers: 25EBC812; 2) Kit SKU DYNDA1857A, Lot Numbers: 25FBH991; 3) Kit SKU DYNDC1978A, Lot Numbers: 25EBC577; 4) Kit SKU DYNDC2367, Lot Numbers: 25EBS434; 5) Kit SKU DYNDC2407B, Lot Numbers: 25FMG170; 6) Kit SKU DYNDC3222A, Lot Numbers: 25EBK184; 7) Kit SKU DYNJ59067A, Lot Numbers: 25EBM461, 25EBD386; 8) Kit SKU PHS950205004B, Lot Numbers: 25FMD059.
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
UDI/DI 10198459230363, Lot Numbers: 25EBU508, 25EBE330.
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
UDI/DI 10653160990666, Lot Number 25EBC648
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808; 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808; 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808; 10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
UDI/DI 10193489918113, Lot Number 25EBD613
Feb 18, 2026
View details →Philips north america llc
High PriorityActive
Spectral CT 7500 on Rails; Product Code (REF): 728334;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Product Code (REF): 728334; UDI-DI: 00884838103627; Serial Numbers: 1005, 1007, 1008;
Feb 18, 2026
View details →Lentocilin s 1200
1 200 000 iu / 4 ml
Low PriorityActive
Lentocilin S 1200 1 Recall
Recalls and safety alerts
Feb 18, 2026
View details →Elekta solutions ab
Low PriorityActive
Leksell Gamma Knives Recall
Recalls and safety alerts
Feb 18, 2026
View details →2566031 ont inc dba south west exposures
Low PriorityActive
Raha Generator Shield Recall
Recalls and safety alerts
Feb 18, 2026
View details →Fda
Low PriorityActive
Universal Viewer - System Feature Recall
Recalls and safety alerts
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
UDI/DI 10193489918007, Lot Number 25EBD612
Feb 18, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); UDI-DIs: (1) 884838085282, (2) 884838099210, (3) 884838116733, (4)N/A; Serial Numbers: All;
Feb 18, 2026
View details →Straumann usa llc
High PriorityActive
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
Feb 18, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
System Model Numbers:(1)722067, (2)722225, (3)722235; UDI-DIs:(1)884838085350, (2)884838099265, (3)884838116788; Serial Numbers: All;
Feb 18, 2026
View details →Intuitive surgical, inc.
High PriorityActive
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
UDI: 00886874119747, Serial: SQ0326, SQ0336, SQ0341, SQ0345, SQ0346, SQ0356, SQ0367, SQ0368, SQ0375, SQ0377, SQ0379, SQ0380, SQ0386, SQ0387, SQ0389, SQ0394, SQ0395, SQ0398, SQ0401, SQ0404, SQ0412, SQ0413, SQ0415, SQ0419, SQ0420, SQ0422, SQ0425, SQ0427, SQ0428, SQ0432, SQ0433, SQ0436, SQ0443, SQ0447, SQ0448, SQ0451, SQ0454, SQ0457, SQ0458, SQ0462, SQ0464, SQ0469, SQ0470, SQ0662, SQ0727, SQ0740, SQ0761
Feb 18, 2026
View details →Avid medical, inc.
High PriorityActive
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Tyvek bag seal issue which may compromise sterility of the kit.
Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028
Feb 18, 2026
View details →Alphatec spine, inc.
High PriorityActive
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Due a design issue where the navigated array connection geometry is incorrect.
Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693
Feb 18, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
System Model Numbers: (1)722227, (2)722231; UDI-DIs: (1)884838099227, (2)884838099258, (3)884838116740; Serial Numbers: All;
Feb 18, 2026
View details →Philips north america llc
High PriorityActive
IQon Spectral CT; Product Code (REF): 728332;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Product Code (REF): 728332; UDI-DI: 00884838059542; Serial Numbers: 60128, 60141, 60151, 60161, 60171, 60181, 60129, 60142, 60152, 60162, 60172, 60182, 60130, 60143, 60153, 60163, 60173, 60132, 60144, 60154, 60164, 60174, 60133, 60145, 60155, 60165, 60175, 60134, 60146, 60156, 60166, 60176, 60136, 60147, 60157, 60167, 60177, 60137, 60148, 60158, 60168, 60178, 60138, 60149, 60159, 60169, 60179, 60139, 60150, 60160, 60170, 60180,
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
401211RH UDI-DI 10197344043736 Lot EP250317; 401222RH UDI-DI 10197344043712 Lot EP250317; 401223RH UDI-DI 10197344043705 Lot EP250317; 401226RH UDI-DI 10197344043699 Lot EP250307 EP250317; 401227RH UDI-DI 10197344043682 Lots EP250307 EP250317; 401260RH UDI-DI 10197344043668 Lot EP250317; 401261RH UDI-DI 10197344043651 Lot EP250317; 401306RH UDI-DI 10197344043620¿ Lot EP250317; 401309RH UDI-DI 10197344043613 Lot EP250317; 401312RH UDI-DI 10197344043583¿ Lot EP250307; 401430RH UDI-DI 10197344043491 Lots EP250307 EP250317; 401433RH UDI-DI 10197344043484 Lots EP250307 EP250317; 401435RH UDI-DI 10197344043460 Lots EP250307 EP250317; 401441RH UDI-DI 10197344043439 Lots EP250307 EP250317; 401442RH UDI-DI 10197344044245 Lot EP250307; 401443RH UDI-DI 10197344044252 Lots EP250307 EP250317; 401448RH UDI-DI 10197344044283 Lot EP250307; 401449RH UDI-DI 10197344044290 Lot EP250307; 401450RH UDI-DI 10197344044306 Lots EP250307 EP250317; 401451RH UDI-DI 10197344044313 EP250307 EP250317; 401474RH UDI-DI 10197344044351 Lot EP250307; 401860RH UDI-DI 10197344044382 Lots EP250307 EP250317; 401877RH UDI-DI 10197344044436 Lots EP250307 EP250317; 401878RH UDI-DI 10197344044443 Lot EP250307; 401890RH UDI-DI 10197344044450 Lots EP250307 EP250317; 401891RH UDI-DI 10197344044467 Lot EP250307; 401994RH UDI-DI 10197344044542 Lot EP250317; 402012RH UDI-DI 10197344043835 Lots EP250307 EP250317; 402004RH UDI-DI 10197344044566 Lots EP250307 EP250317; 402010RH UDI-DI 10197344044597 Lots EP250307 EP250317; 402008RH UDI-DI 10197344044573 Lot EP250317; 402009RH UDI-DI 10197344044580 Lots EP250307 EP250317
Feb 18, 2026
View details →Surepulse medical ltd
High PriorityActive
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
DI Number: 05060550650013/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
Feb 18, 2026
View details →Steris corporation
High PriorityActive
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829
Feb 18, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
System Model Numbers: (1) 722063, (2) 722221, (3) 722229; UDI-DIs: (1) 884838085275, (2) 884838099203, (3) 884838116726; Serial Numbers: All;
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
UDI/DI 10193489217070, Lot Number 25EBJ414
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
1) Kit SKU DM320C, UDI/DI 10653160997504, Lot Number 25EBQ881; 2) Kit SKU DT15780A, UDI/DI 10653160323303, Lot Number 25EBH827; 3) Kit SKU DT16615, UDI/DI 10653160259268, Lot Number 25EBC730; 4) Kit SKU DT19660, UDI/DI 10653160283041, Lot Number 25EBD629; 5) Kit SKU DT19665, UDI/DI 10653160283263, Lot Number 25EBU086; 6) Kit SKU DT21495, UDI/DI 10653160320593, Lot Number 25EMJ081; 7) Kit SKU DT22510A, UDI/DI 10193489499247, Lot Number 25EMJ351; 8) Kit SKU DYNDC3114B, UDI/DI 10198459078880, Lot Number 25EBI085; 9) Kit SKU DYNDC3351, UDI/DI 10195327475482, Lot Number 25EBM451.
Feb 18, 2026
View details →Surepulse medical ltd
High PriorityActive
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
DI Number: 05060550650006/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
Feb 18, 2026
View details →Alphatec spine, inc.
High PriorityActive
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Due a design issue where the navigated array connection geometry is incorrect.
Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
UDI/DI 10195327379308, Lot Number 25EBO576
Feb 18, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
System Model Numbers: (1)722068, (2)722226, (3)722236; UDI-DIs: (1)884838085367, (2)884838099272, (3)884838116801; Serial Numbers: All;
Feb 18, 2026
View details →Elekta, inc.
High PriorityActive
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Lot Code: 07340048311236 (LGP 11.1)
Feb 18, 2026
View details →Medline industries, lp
High PriorityActive
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
Feb 18, 2026
View details →Philips medical systems nederland b.v.
High PriorityActive
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); UDI-DIs: (1)884838099234, (2)884838116757, (3)N/A; Serial Numbers: All;
Feb 18, 2026
View details →Surepulse medical ltd
High PriorityActive
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
DI Number: 05060550650044/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
Feb 18, 2026
View details →Hologic, inc
High PriorityActive
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Feb 18, 2026
View details →Erbe elektromedizin gmbh
Low PriorityActive
Erbe Flexible Cryoprobe Recall
Recalls and safety alerts
Feb 17, 2026
View details →Apotex inc.
Low PriorityActive
APO-CANDESARTAN: Affected lots were manufactured u... Recall
Recalls and safety alerts
Feb 16, 2026
View details →Fda
Low PriorityActive
Trilogy EVO and EV300 Recall
Recalls and safety alerts
Feb 13, 2026
View details →Medline industries, lp
Low PriorityActive
Medline Kits containing Surgical Gowns Recall
Recalls and safety alerts
Feb 11, 2026
View details →Derma sciences, inc.
Medium PriorityActive
Medihoney® Wound and Burn Products Recall
Recalls and safety alerts
Feb 11, 2026
View details →Olympus medical systems corp.
Low PriorityActive
VISERA™ Imaging System Recall
Recalls and safety alerts
Feb 10, 2026
View details →Canon medical systems corporation
Low PriorityActive
Alphenix Systems Recall
Recalls and safety alerts
Feb 10, 2026
View details →Fda
Low PriorityActive
TARO-CANDESARTAN: Affected lots were manufactured ... Recall
Recalls and safety alerts
Feb 9, 2026
View details →Fresenius kabi canada ltd.
Low PriorityActive
Cefazolin for Injection: Affected lots are package... Recall
Recalls and safety alerts
Feb 9, 2026
View details →Marcan pharmaceuticals
Low PriorityActive
MAR-AMLODIPINE: affected lots may contain tablet(s... Recall
Recalls and safety alerts
Feb 9, 2026
View details →Fda
Low PriorityActive
Two lots of MAR-Amlodipine Recall
Recalls and safety alerts
Feb 7, 2026
View details →Olympus medical systems corp.
Low PriorityActive
UHI-3 High Flow Insufflation System - Insufflator Recall
Recalls and safety alerts
Feb 6, 2026
View details →Philips medizin systeme boblingen gmbh
Low PriorityActive
Philips IntelliVue Patient Monitors Recall
Recalls and safety alerts
Nov 18, 2025
View details →Track Recalls Automatically
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