BEUDAMED
    FDA Enforcement Class II Ongoing

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    Recall: Z-1395-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1395-2025
    Event ID
    96278
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remel, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2025
    Initiation Date
    February 12, 2025
    Classification Date
    March 19, 2025
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    Reason

    Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.

    Code Info

    UDI-DI 05032384545872. Detailed list of affected Zebra printer models: https://www.zebra.com/us/en/power-supply-recall.html Please check the manufacturing label found either on the back or bottom of your printer. If the label lists Zebra Technologies as the manufacturer, please use the validation form on the Zebra website to fully validate if your power supply is affected: https://connect.zebra.com/safeguard

    Distribution

    Domestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH, PA, TN, TX, WI. International distribution to Canada and the Bahamas.

    Quantity

    41