Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Summary
The FDA issued a Class II for Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP- by Jewel Precision Sheet Metal & Machining Co, Inc.. Reason: 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.
Details
Source
Device Recall
External ID
Z-2033-2025
Action Date
2025-07-02
Status
Ongoing
Category
device
Product Description
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Lot/Code Info: Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899
Quantity Affected: 1
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.
Distribution
US distribution to Tennessee.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-23
Company
Cedar Grove, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Jewel Precision Sheet Metal & Machining Co, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jewel Precision Sheet Metal & Machining Co, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jewel Precision Sheet Metal & Machining Co, Inc. have FDA actions?
Jewel Precision Sheet Metal & Machining Co, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2033-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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