BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2026-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-2026-2025
    Event ID
    96957
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Jewel Precision Sheet Metal & Machining Co, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 2, 2025
    Initiation Date
    May 22, 2025
    Classification Date
    June 25, 2025
    Address
    200 Commerce Rd, Cedar Grove, NJ, 07009-1209, United States

    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.

    Code Info

    Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.

    Distribution

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

    Quantity

    11 units