Medline Industries Recalls Convenience Kits Over Potential Sterility Assurance Issues

What Happened

Medline Industries, LP has initiated a voluntary Class II recall of specific convenience kits after identifying calibration issues with equipment used for sterilization and packaging. While the products were processed through validated sterilization cycles, the calibration discrepancies have the potential to impact the sterility assurance level (SAL) of the devices.

Which Products Are Affected

The recall involves 32 units of the following medical device:

• Product Name: Medline Convenience Kits: WMC I D PACK-LF
• Model Number: DYNJ50806L
• Lot Number: 23FBK937
• UDI-DI: 10195327344672 (each), 40195327344673 (case)
• Recall Number: Z-1403-2026

The affected products were distributed worldwide, including nationwide across the United States.

What You Should Do

Consumers and healthcare providers should immediately inspect their inventory for the affected lot number (23FBK937). Medline Industries notified customers of the issue via a formal letter initiated on January 7, 2026. If you are in possession of the recalled kits, follow the instructions provided in the firm’s notification regarding the return or quarantine of the product. For further inquiries, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.

Why This Matters

Compromised sterility in medical kits poses a risk of infection or other adverse health complications for patients. This recall ensures that potentially non-sterile equipment is removed from clinical use to maintain patient safety.

Source

Recall information provided by the FDA.