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Disposable Surgical Gowns

Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Model SUM201022-L · UDI-DI 06938024400138

FYA Prescription

510(k) clearances

780

Adverse events

129

Recalls

225

Facilities

Recalls

Date	Firm	Reason
2026-01-28	Medline Industries, LP	Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in p
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2025-11-12	Cardinal Health 200, LLC	Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
2023-11-29	MEDLINE INDUSTRIES, LP - Northfield	Surgical gowns were manufactured with the wrong sleeve.
2022-10-31	Owens & Minor Distribution, Inc.	Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
2022-09-01	Texas Medical Technology Inc.	Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., bloo
2021-11-02	Cardinal Health	Potential for open packaging seals compromising the sterility of the surgical gowns
2021-11-02	Cardinal Health	Potential for open packaging seals compromising the sterility of the surgical gowns

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.