FDA Device recall Z-2033-2025
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 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2033-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-23 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Jewel Precision Sheet Metal And Machining |
| Distribution | TN |
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Reason
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
Identifiers
| code_info | Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899 |
|---|
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-2033-2025%22
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