Medline Recalls Convenience GI Kits Over Potential Sterility Assurance Issues

What Happened

Medline Industries, LP has initiated a voluntary recall of specific convenience kits used in gastrointestinal (GI) procedures. The company identified calibration issues with the equipment used to sterilize and package these devices. Although the products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the affected units.

Which Products Are Affected

The recall involves approximately 23,238 units distributed nationwide in the United States and worldwide. The affected products include:

1. BAPTIST FLOYD ENDO GI KIT

   • Model Number: DYKE1455B
   • UDI-DI: 10193489760781 (each), 40193489760782 (case)
   • Lot Number: 22IBV801

2. GI LAB OTHER ENDO KIT

   • Model Number: DYKE1721
   • UDI-DI: 10193489258684 (each), 40193489258685 (case)
   • Lot Numbers: 23KMC417, 23IMF495, 23HMG566, 23GMF416, 23GMC067, 23EMF635, 23CMG332, 23CMC558, 23CMB706, 23BMC768, 22LMF786, 22JMC784, 22HMD809, 22GMH729, 22FMH954, 22FMD365, 22EMI534, 22EMH737, 21KBP287, 21IBL687, 21CBH946, 21CBH534, 21BBK795.

What You Should Do

Medline Industries, LP 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. If you possess these products, follow the instructions provided in the firm’s notification letter regarding the return or disposal of the affected kits.

Why This Matters

This recall is significant because medical devices used in GI procedures must maintain a specific sterility assurance level to prevent patient infections. A failure in the sterilization process poses a potential health risk to patients undergoing medical interventions.

Source

Information provided by the FDA. Recall Number: Z-1396-2026.