Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Summary
The FDA issued a Class II for Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Num by Jewel Precision Sheet Metal & Machining Co, Inc.. Reason: The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life..
Details
Source
Device Recall
External ID
Z-2026-2025
Action Date
2025-07-02
Status
Ongoing
Category
device
Product Description
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Lot/Code Info: Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.
Quantity Affected: 11 units
Reason for Recall
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Distribution
US Nationwide distribution in the states of IN, NY, PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-22
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-2026-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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