FDA Medical devices recall ·
Jewel Precision Reusable Rigid Sterilization Container System recall
- Recall number
- Z-2033-2025
- Date
- (initiated May 23, 2025)
- Company / brand
- Jewel Precision Sheet Metal & Machining Co, Inc.
200 Commerce Rd, Cedar Grove, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899
Distribution
US distribution to Tennessee.
States: Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2033-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.