Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
FDA device recall Z-2026-2025 · posted 2025-06-25 · Open, Classified
Recall details
- Recalling firm
- Jewel Precision Sheet Metal & Machining Co, Inc.
- Reason for recall
- The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
- Action taken
- Jewel Precision notified consignees on about 05/22/2025 via email. Consignees were instructed to acknowledge the notification, inform Jewel Precision of their distribution of the products, obtain old Instructions for Use from their customers, return any obsolete Instructions for Use to Jewel Precision, and send updated Instructions for Use to their customers.
- Root cause
- No Marketing Application
- Status
- Open, Classified
- Product code
- KCT
- Quantity affected
- 11 units
- Distribution
- US Nationwide distribution in the states of IN, NY, PA.
- Date initiated
- 2025-05-22
- Date posted
- 2025-06-25
- Location
- Cedar Grove, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Jewel Precision Reusable Rigid Sterilization Container System (K162600) | Jewel Precision Sheet Metal & Machine, Inc. | 2016-12-09 |