Recall Z-2026-2025 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
| Date | Jun 25, 2025 (initiated May 22, 2025) |
| Status | Open, Classified |
| Reason | The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life. |
| Root cause | No Marketing Application |
| Action | 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. |
| Quantity | 11 units |
| Distribution | US Nationwide distribution in the states of IN, NY, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162600 | Jewel Precision Reusable Rigid Sterilization Container System Jewel Precision Sheet Metal & Machine, Inc., Dec 9, 2016 |