Jewel Precision Sterilization Container (Jewel Precision) – FDA Clearance Problem (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Brand
Jewel Precision Sheet Metal & Machining Co, Inc.
Lot Codes / Batch Numbers
Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899
Products Sold
Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899
Jewel Precision Sheet Metal & Machining Co, Inc. is recalling Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8. due to 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 le. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TN
Page updated: Jan 10, 2026