BEUDAMED
    FDA Enforcement Class III Ongoing

    One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

    Recall: Z-0226-2026 · Reported October 29, 2025

    Enforcement

    Recall Number
    Z-0226-2026
    Event ID
    97350
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Home Health US, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2025
    Initiation Date
    July 25, 2025
    Classification Date
    October 21, 2025
    Address
    7672 15th St E, Sarasota, FL, 34243-3213, United States

    Description

    One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

    Reason

    Due to incorrect/lack of Unique Device Identifier (UDI) codes.

    Code Info

    UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201

    Distribution

    U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A

    Quantity

    4,661 lancets