BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2026-2025 · Initiated May 22, 2025

    Recall

    Recall Number
    Z-2026-2025
    Event Number
    96957
    Firm
    Jewel Precision Sheet Metal & Machining Co, Inc.
    FEI Number
    3004112448
    Product Code
    KCT
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    May 22, 2025
    Posted
    June 25, 2025
    Address
    200 Commerce Rd, Cedar Grove, NJ, 07009-1209

    Description

    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.

    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.

    Distribution

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

    Quantity

    11 units