FDA Device recall Z-2026-2025
Jewel Precision Reusable Rigid Sterilization Container System
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of Jewel Precision Reusable Rigid Sterilization Container System by Jewel Precision Sheet Metal And Machining, citing the Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2026-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-22 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Jewel Precision Sheet Metal And Machining |
| Distribution | US |
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Reason
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Identifiers
| code_info | Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2026-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.