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Open, Classified

Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.

FDA Recall Z-2026-2025 · Posted 2025-06-25

Recalling FirmJewel Precision Sheet Metal & Machining Co, Inc.
Recall StatusOpen, Classified
Product CodeKCT
Date Initiated2025-05-22
Product Quantity11 units

Reason for Recall

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

Firm Action

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.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution in the states of IN, NY, PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. · 2016-12-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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