Home › Caldera Medical, Inc. › Benesta Sterilization Tray
Benesta Sterilization Tray
Caldera Medical, Inc. · Model CAL-TR131 · UDI-DI 00857492008065
KCT
Prescription
1
510(k) clearances
348
Adverse events
38
Recalls
296
Facilities
Description
The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Lens Hysteroscope and accessories during sterilization and storage.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.