medline industries, lpmedicalHigh 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 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 was recalled because 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.. 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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Key facts

Date announced: February 25, 2026
Source agency: FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

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.

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.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand: Medline industries, lp
Category: medical
Source agency: FDA
Announced: February 25, 2026
Country: US
Status: Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

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

#	Model
1	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

Model

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.

Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: February 25, 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 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.

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the medline industries, lp 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-1411-2026&limit=1

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