Medline Industries Recalls 82,597 Surgical Convenience Kits Over Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary Class II recall of various surgical convenience kits. The company identified issues related to the calibration of equipment used during the sterilization and packaging process. While all affected products were exposed to 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 82,597 units distributed nationwide in the United States and worldwide. Affected products include a wide range of Medline Convenience Kits, including but not limited to:

• Major and Minor Laparotomy CDS: Model numbers CDS860015U, CDS860015V, CDS860015W, CDS860015X, CDS860016P, CDS860016Q, CDS860016R, CDS860016S.
• Robotic and Laparoscopy Kits: Model numbers CDS984244J, CDS985422I, CDS985429L, CDS985558N, CDS985558O.
• Specialized Surgical Bundles (DYKMBNDL Series): Including kits for Gastric Bypass, Cysto, Endo, General Surgery Exlap, Urology Prostate, Penile Repair, and Thoracic Robotic Lobectomy.
• Specific Lot Numbers: The recall covers a vast range of lot numbers beginning with prefixes such as 21, 22, 23, 24, and 25 (e.g., 21LBT172, 25EBQ940, 24CDA326).

Official Recall Number: Z-1395-2026.

What You Should Do

Medline Industries notified affected customers via a formal letter. Healthcare providers and distributors should immediately check their inventory for the model and lot numbers listed in the recall. Affected products should be quarantined and not used in clinical settings. For instructions on returning products or obtaining refunds, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

Sterility is a critical requirement for surgical instruments and convenience kits. If the Sterility Assurance Level is compromised, there is an increased risk of patient infection during surgical procedures. This recall ensures that potentially non-sterile equipment is removed from medical environments to protect patient health.

Source

This information is provided by the FDA and is based on official recall event ID 98329.