Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
FDA Recall #Z-2026-2025 — Class II — May 22, 2025
Product Description
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Reason for Recall
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Recalling Firm
Jewel Precision Sheet Metal & Machining Co, Inc. — Cedar Grove, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
11 units
Distribution
US Nationwide distribution in the states of IN, NY, PA.
Code Information
Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated