Reported Feb 25, 2026 · Ongoing
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035;…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Medline Convenience Kits1) LVAD DRIVELINE TRAY
- Model Number
DM1035A2) LVAD DRIVELINE TRAY
- Model Number
DM10353) CENTRAL LINE DRESSING CHANGE TRAY
- Model NumberDT8670A
- Lot codes and dates
11 of 11 products
Products covered by this recall # Barcodes Product as published 1 1065316034525100653160345254Lot Number: 2025051290; 2) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case) 2 1065316034525100653160345254Lot Number: 2025031190; 3) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case) 3 1065316034525100653160345254Lot Number: 2023062390; 4) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case) 4 1065316034525100653160345254Lot Number: 2023101290; 5) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case) 5 1065316034525100653160345254Lot Number: 2022030390; 6) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case) 6 1065316032775200653160327755Lot Number: 2022072590; 7) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case) 7 1065316032775200653160327755Lot Number: 2020042290; 8) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case) 8 1065316032775200653160327755Lot Number: 2020052290; 9) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case) 9 1065316032775200653160327755Lot Number: 2020072290; 10) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case) 10 0065316017747310653160177470Lot Number: 2020082690; 11) DT8670A, UDI-DI: 00653160177473(each), 10653160177470(case) 11 Lot Number: 2020051390 - Amount recalled
- 9720 units
This recall covers 43 products
The agency filed one notice per product. You are reading one of them; the other 42 are below.
30 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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