Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor was recalled because retroactively reported; labeling contains incorrect sizing guide for cap, a component of the heart rate monitor.. If you have this product, stop using it until you verify your lot or model details.
By RecallRadar Editorial Team
Sourced from FDA. Last verified March 15, 2026.
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Check if you qualifyKey facts
- Date announced
- February 18, 2026
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor was recalled because retroactively reported; labeling contains incorrect sizing guide for cap, a component of the heart rate monitor.. If you have this product, stop using it until you verify your lot or model details.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Surepulse medical ltd
- Category
- medical
- Source agency
- FDA
- Announced
- February 18, 2026
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
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
| # | Model |
|---|---|
| 1 | 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 |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1Stop using the affected product until you verify whether your item is impacted.
- 2Check the official recall notice and match your model, lot, or serial details.
- 3Follow the official instructions for repair, replacement, refund, or disposal.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- February 18, 2026
- Last reviewed by RecallRadar
- March 15, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists 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.
What is the remedy for this recall?
Follow the official instructions for repair, replacement, refund, or disposal on the surepulse medical ltd recall page.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1358-2026&limit=1
Keep browsing with these internal hubs: surepulse medical ltd recall hub and Medical recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
View official notice from FDASee an inaccuracy?
Help us improve the accuracy of this recall information.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- February 18, 2026
- Source agency
- FDA
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