FDA Medical devices recall ·
Jewel Precision Reusable Rigid Sterilization Container System recall
- Recall number
- Z-2026-2025
- Date
- (initiated May 22, 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
- 11 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Why was it recalled?
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
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-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.
Distribution
US Nationwide distribution in the states of IN, NY, PA.
States: Indiana New York Pennsylvania
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-2026-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.