Home › Device types › PUI
Drape, Surgical, Exempt
FDA product code PUI · Class 2 · General, Plastic Surgery
6,690
Registered devices
471
Adverse events
41
Recalls
0
510(k) clearances
Devices with this code
Bioseal Inc. — BIOSEALMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline-Microtek — Microtek Medical LLCInvenio — GRI Medical & Electronic Technology Co., Ltd.Invenio — GRI Medical & Electronic Technology Co., Ltd.Medline-Microtek — Microtek Medical LLCCONVERTORS — Cardinal Health 200, LLCHalyard — O&M HALYARD, INC.Halyard — O&M HALYARD, INC.Steri-Drape™ — 3M COMPANYHalyard — O&M HALYARD, INC.CONVERTORS — Cardinal Health 200, LLCMedline-Microtek — Microtek Medical LLCORA SYSTEM, VerifEye — Alcon Laboratories, Inc.Halyard — O&M HALYARD, INC.OEC — TIDI PRODUCTS, LLCCONVERTORS — Cardinal Health 200, LLCCONVERTORS — Cardinal Health 200, LLCHALYARD — GRI Medical & Electronic Technology Co., Ltd.CONVERTORS — Cardinal Health 200, LLCCONVERTORS — Cardinal Health 200, LLCCONVERTORS — Cardinal Health 200, LLCMedline-Microtek — Microtek Medical LLCBeaver Visitec Inter — GRI Medical & Electronic Technology Co., Ltd.
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 |
| 2025-04-13 | Microtek Medical, Inc. | Due to non-sterile products being labeled as sterile |
| 2025-02-13 | MEDLINE INDUSTRIES, LP - Northfield | Potential breach in pouch packaging which could lead to loss of sterility. |
| 2023-06-23 | Microtek Medical Inc. | Certain lots of the products have a Naphthalene odor. |
| 2022-10-06 | 3M Healthcare Business | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and m |
| 2022-10-06 | 3M Healthcare Business | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and m |
| 2022-10-06 | 3M Healthcare Business | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and m |
| 2022-10-06 | 3M Healthcare Business | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and m |
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