Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP…

The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2026-2025
• FDA 510(k) clearance · K162600The device's official FDA premarket clearance record
• FDA device classification · KCTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.6850The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Jewel Precision Sheet Metal & Machining Co, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.