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Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
FDA product code KCT · Class 2 · General Hospital
16,088
Registered devices
348
Adverse events
38
Recalls
282
510(k) clearances
Devices with this code
XLIF — Nuvasive, Inc.INSTRUSAFE — Summit Medical, Inc.INSTRUSAFE — Summit Medical, Inc.INSTRUSAFE — Summit Medical, Inc.INSTRUSAFE — Summit Medical, Inc.ERMIS — Ermis MedTech GmbHINLET System Surgical Instrument — Jeil Medical CorporationINSTRUSAFE — Summit Medical, Inc.ERMIS — Ermis MedTech GmbHPro-Lite — STERIS CORPORATIONMedtronic Transportation/Sterilization Cassette — MEDTRONIC SOFAMOR DANEK, INC.BAHADIR USA — BAHADIR USA LLCV. Mueller — CAREFUSION 2200, INCCoRoent — Nuvasive, Inc.ERMIS — Ermis MedTech GmbHSumma Orthopaedics System Surgical Instrument — Jeil Medical CorporationV. Mueller — STERIS CORPORATIONBAHADIR USA — BAHADIR USA LLCV. Mueller — STERIS CORPORATIONMillennium — Avalign Technologies, Inc.Instrusafe — Summit Medical, Inc.Instrusafe — Summit Medical, Inc.INSTRUSAFE — Summit Medical, Inc.INSTRUSAFE — Summit Medical, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-23 | Jewel Precision Sheet Metal & Machining Co, Inc. | The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to fi |
| 2025-05-22 | Jewel Precision Sheet Metal & Machining Co, Inc. | The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life. |
| 2025-05-01 | Implant Direct Sybron Manufacturing LLC | The Drill stop kit contains incorrect components. |
| 2023-04-06 | Karl Storz Endoscopy | Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time |
| 2023-04-05 | Karl Storz Endoscopy | Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first ti |
| 2023-01-30 | Carefusion 2200 Inc | Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment. |
| 2022-09-26 | Carefusion 2200 Inc | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
| 2022-09-26 | Carefusion 2200 Inc | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
| 2022-09-26 | Carefusion 2200 Inc | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
| 2022-09-26 | Carefusion 2200 Inc | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. |
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