Medline Industries Recalls Convenience Kits Due to Potential Sterility Assurance Issues

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 affected 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 involves 551 units distributed nationwide in the United States and worldwide. The affected products include:

1. ANCILLARY PACK-LF

   • Model Number: DYNJ0185290G
   • UDI-DI: 10193489378054 (each), 40193489378055 (case)
   • Lot Number: 22LBQ336

2. OPEN HEART ANESTHESIA ICC-A

   • Model Number: DYNJ905567A
   • UDI-DI: 10193489348927 (each), 40193489348928 (case)
   • Lot Numbers: 24BBN429, 23KBI089, 23HBG596, 23FBL644, 23FBG152, 23EBH550, 23CBQ546, 22NBF780, 22LBC300, 22HBP453, 22HBM263, 22HBF686, 22CBY841, 21KBR457, 21KBA253, 21IBH675, 21GBE802, 21EBE777

What You Should Do

Medline Industries notified affected customers via a formal letter initiated on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or credits, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

Sterility is critical for medical devices used in clinical and surgical environments. A failure to meet the required Sterility Assurance Level could potentially expose patients to pathogens, increasing the risk of infection during medical procedures.

Source

This recall is documented by the FDA under recall number Z-1384-2026.