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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Jewel Precision Sterilization Containers Recalled for Lack of FDA Clearance

Agency Publication Date: June 26, 2025
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Summary

Jewel Precision Sheet Metal & Machining Co, Inc. has recalled one unit of its Jewel Precision Reusable Rigid Sterilization Container System (Model JP-24-8). This 8-inch model was not cleared by the FDA for use, and the documentation provided to justify the change in size was found to be insufficient. The affected unit was distributed to a customer in Tennessee.

Risk

Using a sterilization container that has not been cleared by the FDA poses a risk that surgical instruments may not be properly sterilized or maintained in a sterile state. This could lead to contaminated medical tools and potential surgical site infections for patients.

What You Should Do

  1. This recall affects one Jewel Precision Reusable Rigid Sterilization Container System, Model Number JP-24-8, with GTIN 00850043393139 and Lot Number 16899.
  2. Stop using the recalled sterilization container immediately.
  3. Contact Jewel Precision Sheet Metal & Machining Co, Inc. or your distributor to arrange for the return, replacement, or correction of the device.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Jewel Precision Reusable Rigid Sterilization Container System
Variants: 8-inch model
Model / REF:
JP-24-8
Lot Numbers:
16899
GTIN:
00850043393139

The 8-inch model was not cleared by the FDA.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96958
Status: Active
Manufacturer: Jewel Precision Sheet Metal & Machining Co, Inc.
Sold By: Specialty medical distributors
Manufactured In: United States
Units Affected: 1
Distributed To: Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.