Z-2026-2025 Class II Ongoing
FDA device recall Z-2026-2025 was initiated by Jewel Precision Sheet Metal & Machining Co, Inc. on May 22, 2025 and is designated Class II. Reason for recall: The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life. The recall status is ongoing. Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- May 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of IN, NY, PA.
Code Information
Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.