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Richard Wolf GmbH · Model 33304 · UDI-DI 04055207070154
10
510(k) clearances
344
Adverse events
38
Recalls
292
Facilities
Description
PERFORATED BASKET INSTRUMENT HOLDER storage and transport, for aligning the axial position of instruments during sterilization (steam and low-temperature)
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 file justifying the ch |
| 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 specific to the tra |
| 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 time specific to the t |
| 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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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.