Jewel Precision Reusable Rigid Sterilization Container… recallZ-2026-2025 · Jewel Precision Sheet Metal & Machining Co, Inc. · initiated May 22, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Jewel Precision Sheet Metal & Machining Co, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
FDA root cause category: No Marketing Application
What the company is doing
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.
Recall details
- Recall number
- Z-2026-2025
- Status
- Open, Classified
- Initiated by the company
- May 22, 2025
- Posted by the FDA
- Jun 25, 2025
- Recalling firm
- Jewel Precision Sheet Metal & Machining Co, Inc.
- Quantity
- 11 units
- Product code
- KCT
- FDA submissions
- K162600
- Distribution
- US Nationwide distribution in the states of IN, NY, PA.
Product description
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Code information (models, lots, serial numbers)
Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Jewel Precision JP-24-6Jewel Precision Sheet Metal & Machining Inc · Sterilization Wrap Containers, Trays, Cassettes & Other Accessories1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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