Medline Industries Recalls Over 14 Million Surgical Drapes Due to Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of approximately 14,927,765 units of various surgical drapes. The recall was prompted by the identification of calibration issues with equipment used during the sterilization and packaging processes. While the products were exposed to validated sterilization cycles, the firm determined that the calibration errors have the potential to impact the sterility assurance level (SAL) of the affected devices.

Which Products Are Affected

The recall involves a vast array of sterile surgical drapes and related products distributed nationwide in the U.S. and worldwide. Affected model numbers include:

• General Surgical Sheets/Drapes: DYNJP2410, DYNJP2411, DYNJP2412, DYNJP2412T, DYNJP2414, DYNJP2414R, DYNJP2414UG, DYNJP2416, DYNJP2417, DYNJP2418, DYNJP2419, DYNJP2462 (Leggings), DYNJP2491, DYNJP2492, DYNJP2498.
• Specialized Procedure Drapes: DYNJP3003, DYNJP3003UG, DYNJP3008, DYNJP3008UG, DYNJP3009 (Laparotomy); DYNJP3101, DYNJP3102A, DYNJP3102UG, DYNJP3103, DYNJP3109 (Abdominal/Laparoscopy); DYNJP4002, DYNJP4003 (Top Drapes); DYNJP4106, DYNJP4119 (Angiography); DYNJP4215; DYNJP6002, DYNJP6006 (Underbuttock); DYNJP7001, DYNJP7003 (EENT/Thyroid).
• Orthopedic and Extremity Drapes: DYNJP8002, DYNJP8002UG, DYNJP8003, DYNJP8003UG, DYNJP8005, DYNJP8005UG (Hand/Extremity); DYNJP8201, DYNJP8201UG, DYNJP8211 (Hip); DYNJP8301, DYNJP8304A, DYNJP8304UG (Split Drapes); DYNJP8412, DYNJP8412UG, DYNJP8414 (Shoulder).
• Lithotomy and Veterinary Drapes: DYNJP9001, DYNJP9103; Veterinary models MED901, MED902, and MED903.

Specific lot numbers and UDI-DI information are associated with each model number. The recall covers products with initiation dates starting January 7, 2026.

What You Should Do

Medline Industries, LP notified customers of the recall via letter. Healthcare facilities, distributors, and consumers should immediately identify and quarantine any affected products in their inventory. For information regarding returns, replacements, or technical questions, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

This recall is classified as Class II, indicating that the use of the affected products may cause temporary or medically reversible adverse health consequences. In this case, compromised sterility in surgical drapes poses a risk of infection to patients during medical procedures.

Source

Information provided by the FDA. Official Recall Number: Z-1423-2026.