Medline Industries Recalls Drape Pack-Choice Convenience Kits Over Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of specific Medline Convenience Kits after identifying calibration issues with the equipment used to sterilize and package the devices. Although the products were exposed to validated sterilization and packaging cycles, the firm determined that the calibration errors have the potential to impact the sterility assurance level (SAL) of the recalled units.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: Medline Convenience Kits: DRAPE PACK-CHOICE
• Model Number: DYNJ63118A
• Lot Number: 25ABV005
• UDI-DI: 10195327644291 (each); 40195327644292 (case)
• Quantity: 72 units
• Recall Number: Z-1406-2026

These units were distributed nationwide within the United States and through worldwide distribution channels.

What You Should Do

Healthcare facilities and distributors should immediately check their inventory for the affected lot number (25ABV005). Affected products should be quarantined and should not be used in clinical settings. Medline Industries began notifying customers of the issue via letter on January 7, 2026. For information regarding the return or replacement of these kits, contact Medline Industries, LP at their headquarters in Northfield, Illinois.

Why This Matters

Compromised sterility in medical devices like drape packs can lead to a significantly increased risk of infection for patients during surgical or medical procedures. Maintaining a high sterility assurance level is critical for patient safety.

Source

Information provided by the FDA.