Home › Device types › FYA
Gown, Surgical
FDA product code FYA · Class 2 · General, Plastic Surgery
2,783
Registered devices
780
Adverse events
129
Recalls
297
510(k) clearances
Devices with this code
Medline — MEDLINE INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCAlleset — GRI Medical & Electronic Technology Co., Ltd.NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCNOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCMedline — MEDLINE INDUSTRIES, INC.CONVERTORS — Cardinal Health 200, LLCPromax Surgical Gown — STANDARD TEXTILE CO., INC.ComPel MLR Surgical Gown — STANDARD TEXTILE CO., INC.ComPel Surgical Gown — STANDARD TEXTILE CO., INC.CONVERTORS — Cardinal Health 200, LLCSRI Healthcare — Elevate Textiles, Inc.Standard Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., LtdSteri-Shield — STRYKER CORPORATIONChemoPlus — Cardinal Health 200, LLCNOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCHalyard — O&M HALYARD, INC.Perval Surgical Gown — STANDARD TEXTILE CO., INC.3A MEDICAL — 3A Medical Products Co.,LtdHalyard — O&M HALYARD, INC.Halyard — Avanos Medical, Inc.Halyard — O&M HALYARD, INC.CARDINAL HEALTH — Cardinal Health 200, LLC
Recent 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 |
| 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 ster |
| 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 ster |
| 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 ster |
| 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 |
| 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 surgi |
| 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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