FDA Medical Device Recalls (openFDA)
Jewel Precision Sheet Metal & Machining Co, Inc.: Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
- Recall number
- Z-2033-2025
- Recalling firm
- Jewel Precision Sheet Metal & Machining Co, Inc.
- Product
- Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
- Status
- Open, Classified
- Initiated
- 2025-05-23
- Posted
- 2025-06-26
- Terminated
- not on file
- Reason
- 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 change in size was insufficient.
- Root cause
- No Marketing Application
- Action
- Jewel Precision sent a "MEDICAL DEVICE RECALL" letter dated 5/23/2025 to the single consignee on 05/23/2025 via email. The consignee was instructed to; review all stock and inventory, return the product to Jewel Precision for destruction, complete the Acknowledgement and Receipt form on pages 3-4 of the letter indicating the actions taken and approval of completion, in the event that the product has been scrapped, please provide evidence of scrapping it and certification that the product has been destroyed by the customer. As per the customer's purchase order, the piece was to be used for testing purposes only. For products that have been shipped to your customers, identify and notify your customers of the recall, requesting return; obtain their acknowledgement and approval that the part has been shipped back. Action by company: discontinued the product. For questions email: jsitler@jewelprecision.com or call 973-857-5545 x19.
- Quantity
- 1
- Distribution
- US distribution to Tennessee.
- Lot, serial or model codes
- Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCT
- Firm FEI
- 3004112448
- Firm city
- Cedar Grove
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28