Medline Industries Recalls Convenience Kits Over Potential Sterility Concerns
Medline Industries, LP is recalling specific LVAD Driveline Trays and Surgical Oncology Kits because calibration issues may have compromised the products' sterility.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific medical convenience kits due to identified issues with the calibration of equipment used during the sterilization and packaging process. While the products were exposed to validated sterilization cycles, the calibration discrepancies have the potential to impact the Sterility Assurance Level (SAL) of the devices.
Which Products Are Affected
The recall affects 684 units distributed nationwide in the United States and worldwide. The specific products and lot numbers include:
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LVAD DRIVELINE TRAY
- Model Number: DM1035
- Lot Number: 21BBN221
- UDI-DI: 10193489442755 (each), 40193489442756 (case)
-
KIT SURG ONC INSERT CENT.VENOU
- Model Number: DYKMBNDL43
- UDI-DI: 10193489478891 (each), 40193489478892 (case)
- Lot Numbers: 22GBN333, 22GBF510, 22EBL039, 22CBU342, 21JBJ253, 21IBJ337, 21DBD662, 21ABO838, 21ABJ003
What You Should Do
Medline Industries notified affected customers through a formal recall letter initiated on January 7, 2026. Healthcare providers and facilities should immediately check their inventory for the affected model and lot numbers. If these products are found, they should be quarantined and handled according to the instructions provided in the firm’s notification letter.
Why This Matters
The sterility of medical kits is critical for patient safety during surgical and clinical procedures. A failure to meet the required Sterility Assurance Level could increase the risk of infection or other medical complications for patients.
Source
Information provided by the FDA under recall number Z-1402-2026.
Source: FDA Official Notice