Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Jewel Precision Reusable Rigid Sterilization Container System. Model Number:JP-24-8GTIN 00850043393139.Affected lot16899
What the firm is doing
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.
DistributionShow detailsHide
US distribution to Tennessee.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2033-2025
- FDA device classification · KCTOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.6850The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Jewel Precision Sheet Metal & Machining Co, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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