Medline Industries, LP — 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:
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 7, 2026
Worldwide distribution - US Nationwide.
What's affected?
- Product
- 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
- Lot code
- 2025051290
Additional details
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 should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 9720 units.
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