Medline Industries Recalls Admit Kits Due to Potential Sterility Compromise

What Happened

Medline Industries, LP has initiated a voluntary recall of specific Medline Convenience Kits after identifying calibration issues with equipment used during the sterilization and packaging process. While the products were exposed to validated sterilization cycles, the identified calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the devices, meaning their sterility cannot be guaranteed.

Which Products Are Affected

The recall involves 1,070 units of the following product:

• Product Name: Medline Convenience Kits: ADMIT KIT
• Model Number: DYKA1343A
• UDI-DI: 10193489312966 (each), 40193489312967 (case)
• Affected Lot Numbers: 25LBC732, 25FBN781, 25DBK346, 24IBD021, 24DBK171, 24BBV821, 23HBP415, 23EBC552, 23CBE825, 22LBR618, 22KBA245, 22EBK467, 22ABE640, 21JBF397, 21IBE395, 21IBB933, 21CBV232.

This recall affects products distributed nationwide across the United States and through worldwide distribution.

What You Should Do

Medline began notifying affected customers via letter on January 7, 2026. Healthcare providers and consumers in possession of these kits should immediately check their inventory for the model and lot numbers listed above. Affected products should be sequestered to prevent use. For specific instructions regarding returns or replacement, contact Medline Industries, LP at their headquarters in Northfield, IL.

Why This Matters

Sterility is critical for medical convenience kits used in clinical settings. A failure in the sterilization assurance level increases the risk of patient infection or other adverse health complications. This Class II recall indicates that the use of the affected product may cause temporary or medically reversible health consequences.

Source

Information provided by the FDA under Recall Number Z-1410-2026.