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CustoMed
KENPAX INTERNATIONAL LIMITED · Model 1 · UDI-DI 04895237141222
10
510(k) clearances
790
Adverse events
129
Recalls
225
Facilities
Description
GOWN SURGICAL POLY-REINFORCED SOFT A garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.
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.