Jewel Precision Reusable Rigid Sterilization Container System — Class II medical device recall Z-2026-2025
Ongoing recall by Jewel Precision Sheet Metal & Machining Co, Inc., reported 2025-07-02, distributed nationwide. The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
| Recall number | Z-2026-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jewel Precision Sheet Metal & Machining Co, Inc., Cedar Grove, NJ, United States |
| Recall initiated | 2025-05-22 |
| Classified | 2025-06-25 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 11 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00850043393016 |
| Model numbers | JP-24-6 |
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Reason for recall
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2026-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.