Recall Z-2033-2025— Jewel Precision Sheet Metal & Machining Co, Inc.
Class II · Ongoing
Class II FDA medical device recall by Jewel Precision Sheet Metal & Machining Co, Inc., initiated 2025-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.. 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..
- Recalling firm
- Jewel Precision Sheet Metal & Machining Co, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-23
- Firm location
- Cedar Grove, NJ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.