Cedar Grove, NJ, United States
Jewel Precision Sheet Metal & Machining Co, Inc. recalls
2 recalls recorded since 2018, most recently on 23 May 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 May 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2033-2025
- Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Ongoing Class II Medical devices
- Recall started
- 22 May 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2026-2025
- Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.