FDA recall Z-2033-2025

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

Product

Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

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.

Key facts

Status: Ongoing
Initiation date: 2025-05-23
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-2033-2025