Medline Industries Recalls Lithotomy Packs Due to Potential Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of specific Lithotomy Packs included in its convenience kits. The company identified calibration issues with the equipment used during the sterilization and packaging process. While all affected products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the sterility assurance level (SAL) of the devices.

Which Products Are Affected

The recall affects 808 units distributed worldwide and nationwide across the United States. The following Medline Convenience Kits are included:

1. LITHOTOMY PACK (Model Number: DYNJ83185)

   • UDI-DI: 10195327247058 (each), 40195327247059 (case)
   • Lot Numbers: 23FDC392, 23CDB552, 23CDA474, 22LDA486

2. LITHOTOMY PACK (Model Number: DYNJ83185A)

   • UDI-DI: 10195327468606 (each), 40195327468607 (case)
   • Lot Numbers: 24KDB955, 24IDB525, 24GDB922, 24FDB302, 24EDB468, 24DDB769, 24CDB829, 24CDB327, 24CDA984, 23HDB637

What You Should Do

Medline began notifying customers of the issue via letter on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed above. Any affected products should be quarantined and handled according to the instructions provided in Medline’s notification. For additional information regarding returns or the recall process, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

A compromised sterility assurance level in surgical equipment poses a risk of infection to patients. This Class II recall indicates that while the hazard may not be immediately life-threatening, the use of these products could lead to temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA under Recall Number Z-1398-2026.