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U.S. Department of Health and Human Services

Class 2 Device Recall Jewel Precision

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 Class 2 Device Recall Jewel Precisionsee related information
Date Initiated by FirmMay 23, 2025
Date PostedJune 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2033-2025
Recall Event ID 96958
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
ProductJewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Code Information Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899
FEI Number 3004112448
Recalling Firm/
Manufacturer		 Jewel Precision Sheet Metal & Machining Co, Inc.
200 Commerce Rd
Cedar Grove NJ 07009-1209
For Additional Information ContactLorenzo Graziano
1-973-8575545 Ext. 15
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		No Marketing Application
ActionJewel 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 in Commerce1
DistributionUS distribution to Tennessee.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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