Medline Industries Recalls PPE Kits Due to Potential Sterility Issues

What Happened

Medline Industries, LP has initiated a voluntary recall of its PPE 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 affects Medline Convenience Kits: PPE KIT, specifically Model Number: DYK1011945P. Approximately 7,575 units are included in this recall. The products were distributed worldwide and nationwide across the United States.

Affected lot numbers include:

• 25IFA006
• 24GFA027, 24FFA115, 24BFA115
• 23LFA050, 23GFA079, 23EFA070, 23EFA007, 23DFA024, 23CFA070, 23BFA124, 23BFA006, 23AFA090, 23AFA049
• 22LFA068, 22JFA111, 22IFA036, 22DFA081, 22CFA086, 22BFA066
• 21KFA114, 21JFA139, 21JFA039, 21IFA100, 21HFA112, 21GFA025, 21FFA074, 21EFA047, 21BFA109

UDI-DI numbers associated with these units are 10884389389973 (each) and 40884389389974 (case).

What You Should Do

Consumers and healthcare providers should immediately check their inventory for the affected model and lot numbers listed above. Medline Industries, LP notified customers of the issue via letter starting in January 2026. If you possess any of the recalled units, follow the instructions provided in the firm’s notification letter regarding the return or disposal of the product.

Why This Matters

Sterility is critical for personal protective equipment used in medical settings. If the sterility assurance level is compromised, there is an increased risk of infection or contamination for both healthcare workers and patients.

Source

Information provided by the FDA under Recall Number Z-1408-2026.