Medline Industries Recalls Over 70 Million Surgical Gowns Due to Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of several models of surgical gowns due to issues related to the calibration of equipment used during the sterilization and packaging process. While all affected products were exposed to validated sterilization and packaging cycles, the identified calibration defects have the potential to impact the sterility assurance level (SAL) of the gowns.

Which Products Are Affected

The recall involves approximately 70,376,042 units distributed nationwide across the United States and worldwide. Affected products include various Medline Surgical Gowns under the following model series:

• Standard Gowns: DYNJP2001, DYNJP2003, DYNJP2004, DYNJP2005, DYNJP2009
• SIRUS Series: DYNJP2001S, DYNJP2002S, DYNJP2002SL, DYNJP2003S, DYNJP2003SL, DYNJP2004S, DYNJP2005S, DYNJP2009S, DYNJP2101S, DYNJP2102S, DYNJP2103S, DYNJP2201S, DYNJP2202S, DYNJP2203S, DYNJP2204S, DYNJP2205S, DYNJP2206S, DYNJP2401, DYNJP2402, DYNJP2403, DYNJP2501, DYNJP2502, DYNJP2503
• ECLIPSE Series: DYNJP2002, DYNJP2101, DYNJP2102, DYNJP2103, DYNJP2201, DYNJP2202, DYNJP2203, DYNJP2204, DYNJP2205, DYNJP2206
• PREVENTION PLUS Series: DYNJP2301P, DYNJP2302P, DYNJP2303P, DYNJP2306P, DYNJP2307P, DYNJP2308P
• ORBIS Series (Level 3): DYNJP2361P, DYNJP2362P, DYNJP2363P, DYNJP2366P, DYNJP2367P, DYNJP2368P, DYNJP2369P

Specific lot numbers and UDI-DI codes for these models are included in the official recall documentation. The recall is identified by FDA Recall Number Z-1424-2026.

What You Should Do

Medline Industries, LP began notifying affected customers via letter on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the affected model numbers and lot numbers. If you have these products in stock, follow the specific instructions provided in the firm’s notification letter regarding the return or disposal of the gowns.

Why This Matters

Surgical gowns are critical for maintaining a sterile field during medical procedures. A potential failure in the sterility assurance level increases the risk of infection for both patients and healthcare providers, though this recall is classified as Class II, indicating the health risk is not immediately life-threatening.

Source

Information provided by the FDA under Recall Number Z-1424-2026.