Medline Industries Recalls Urology Convenience Kits Over Sterility Assurance Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of several urology convenience kits due to identified issues with the calibration of equipment used during the sterilization and packaging process. While all 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

A total of 59 units are included in this recall. The affected products were distributed nationwide in the United States and worldwide. The recall includes the following Medline Convenience Kits:

• KIT UROLOGY SLING
  • Model: DYKMBNDL106 (Lots: 21BBG085, 21ABJ542)
  • Model: DYKMBNDL106A (Lots: 22CLA049, 22BLB059, 22ALA713, 21KLA631)
• KIT UROLOGY PENILE REPAIR
  • Model: DYKMBNDL188 (Lots: 21CBS043, 21ABS540, 21ABS539)
• KIT UROLOGY PERIPHERAL STIMULA
  • Model: DYKMBNDL189 (Lots: 21BBG092, 21ABI996)
  • Model: DYKMBNDL189A (Lot: 21JLA521)

Official Recall Number: Z-1416-2026.

What You Should Do

Medline Industries notified affected customers via letter starting 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 specific guidance, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

This recall is significant because compromised sterility in medical devices used for urological procedures can increase the risk of patient infection or other medical complications. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA.