Jewel Precision Sheet Metal & Machining Co, Inc.: Device Recall

Recall #Z-2026-2025 · 05/22/2025

Class II: Risk

Recall Details

Recall Number: Z-2026-2025
Classification: Class II
Product Type: Device
Recalling Firm: Jewel Precision Sheet Metal & Machining Co, Inc.
Status: Ongoing
Date Initiated: 05/22/2025
Location: Cedar Grove, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11 units

Reason for Recall

The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.

Product Description

Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.

Distribution Pattern

US Nationwide distribution in the states of IN, NY, PA.

Other Recalls by Jewel Precision Sheet Metal & Machining Co, Inc.

Class II: Risk 05/23/2025

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.

View all recalls by Jewel Precision Sheet Metal & Machining Co, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.