Recall Z-2026-2025— Jewel Precision Sheet Metal & Machining Co, Inc.
Class II · Ongoing
Class II FDA medical device recall by Jewel Precision Sheet Metal & Machining Co, Inc., initiated 2025-05-22. It names one FDA 510(k) clearance: K162600. 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..
- Recalling firm
- Jewel Precision Sheet Metal & Machining Co, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-22
- Firm location
- Cedar Grove, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.