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YADU
HENAN YADU INDUSTRY CO., LTD. · Model SY0179 · UDI-DI 06946015152256
1
510(k) clearances
790
Adverse events
129
Recalls
225
Facilities
Description
YADU Surgical Gowns are intended to be worn by operating room personnel during surgical procedure to protect boththe surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulatematerial. The surgical gowns meet the requirements for Level 2 and Level 3 classification Per ANSI/AAMI PB70.
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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Get your free API keyRead the docsData 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.