Medline Industries Recalls Over 14 Million Surgical Drapes Due to Sterility Concerns
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Medline Industries, LP has voluntarily recalled nearly 15 million surgical drapes due to equipment calibration issues that may compromise the sterility assurance level of the products.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on March 4, 2026 and geographically references National. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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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.
Original source: FDA Official Notice ↗
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