Home › Device types › KKX
Drape, Surgical, Antimicrobial
FDA product code KKX · Class 2 · General, Plastic Surgery
6,458
Registered devices
803
Adverse events
91
Recalls
450
510(k) clearances
Devices with this code
Tex-Care Medical — Flynt/Amtex, Inc.Exact Medical Manufacturing, Inc. — EXACT MEDICAL MANUFACTURING, INC.Lac-Mac — Lac-Mac LimitedHalyard — O&M HALYARD, INC.ACE — ACE SURGICAL SUPPLY CO., INC.MICROTEK — Microtek Medical LLCExact Medical Manufacturing, Inc. — EXACT MEDICAL MANUFACTURING, INC.Surgical Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.Medline — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Visitec — Beaver-Visitec International, Inc.CONVERTORS — Cardinal Health 200, LLCNA — WELMED INC.Exact Medical Manufacturing, Inc. — EXACT MEDICAL MANUFACTURING, INC.MICROTEK — Microtek Medical LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Halyard — O&M HALYARD, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CONVERTORS — Cardinal Health 200, LLCExact Medical Manufacturing, Inc. — EXACT MEDICAL MANUFACTURING, INC.PremierPro — PRESTIGE AMERITECH, LTD.DeRoyal — DEROYAL INDUSTRIES, INC.OEC — TIDI PRODUCTS, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-27 | Medline Industries, LP | Unapproved design changes to the products outside of the 510(k) clearance. |
| 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 |
| 2025-07-17 | O&M HALYARD INC | Surgical drape packs may have open seals, which may compromise the sterility of the product. |
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-11-26 | O&M HALYARD, INC. | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. |
| 2024-09-04 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2022-12-07 | MEDLINE INDUSTRIES, LP - Northfield | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st |
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