Medline Industries Recalls Over 193,000 Surgical Packs Due to Sterilization Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of specific surgical packs after identifying calibration issues with the equipment used for sterilization and packaging. Although the products were processed through validated sterilization cycles, the calibration errors have the potential to negatively impact the sterility assurance level (SAL) of the devices.

Which Products Are Affected

The recall affects a total of 193,157 units distributed worldwide and nationwide across the United States. The following products are included:

• Universal Ultragard Pack (5/CS): Model Number DYNJP1050UG. Affected lot numbers include 72525030011, 72525050004, 72525100025, 72525100068, 72525020012, 72525040038, 72525060015, 72525060041, 72525080004, 72525080039, and dozens of others listed under UDI-DI 10080196573509.
• Shoulder Drape Pouch Pack (10/CS): Model Number DYNJP8401. Affected Lot Number: 72521080034 (UDI-DI: 10080196740710).

What You Should Do

Medline Industries began notifying customers of the recall via letter on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the affected model and lot numbers. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information, parties may contact Medline Industries, LP at their Northfield, IL headquarters located at 3 Lakes Dr, 60093-2753.

Why This Matters

This recall is significant because surgical packs must maintain a specific sterility assurance level to prevent patient infections during invasive procedures. A failure in the sterilization process calibration poses a potential health risk to patients.

Source

This information is based on an official Class II recall notice from the FDA. Recall Number: Z-1425-2026.