BEUDAMED
    FDA Enforcement Class II Ongoing

    Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

    Recall: Z-2033-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-2033-2025
    Event ID
    96958
    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 23, 2025
    Classification Date
    June 26, 2025
    Address
    200 Commerce Rd, Cedar Grove, NJ, 07009-1209, United States

    Description

    Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

    Reason

    The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.

    Code Info

    Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899

    Distribution

    US distribution to Tennessee.

    Quantity

    1