Medline Industries Recalls General Closure Convenience Kits Over Sterility Assurance Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of specific convenience kits used for general closures. The company identified issues related to the calibration of equipment used during the sterilization and packaging process. Although 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 the Medline Convenience Kits: KIT GENERAL CLOSURE, specifically Model Number: DYKMBNDL200A. A total of 108 units are included in this recall.

The affected products can be identified by the following codes:

• UDI-DI: 10195327240592 (each), 40195327240593 (case)
• Lot Numbers: 25HBD027, 25FBD161, 25EBN454, 25EBG142, 25EBE995, 25DBE771, 25CBB549, 25BBS071, 25BBB895, 24FBK537, 24CBK339, 24ABH890, 23KBA331, and 22KBD675.

The distribution of these products was nationwide across the United States and worldwide.

What You Should Do

Medline Industries notified affected customers via a formal letter. Facilities and healthcare providers 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 by Medline. For further information or to coordinate returns, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.

Why This Matters

The sterility of medical devices is critical for patient safety. If the sterility assurance level is compromised, there is an increased risk of infection or other adverse health consequences for patients undergoing procedures where these kits are used.

Source

Information provided by the FDA under recall number Z-1405-2026.