FDA recall Z-2026-2025

Jewel Precision Sheet Metal & Machining Co, Inc. · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-05-22
Report date
2025-07-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cedar Grove, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2026-2025