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RecallWatchMedical Device Safety
Class IIOngoingZ-2033-2025

Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

Jewel Precision Sheet Metal & Machining Co, Inc.Cedar Grove, NJ, United StatesReported Jul 2, 2025 · 1 year ago
Legal News Analyst ·

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-24-8
    GTIN 00850043393139.
    Affected lot
    16899

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 details

US distribution to Tennessee.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

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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