BEUDAMED
    FDA Enforcement Class II Ongoing

    SQ40S Blood Transfusion Filter

    Recall: Z-1157-2026 · Reported January 28, 2026

    Enforcement

    Recall Number
    Z-1157-2026
    Event ID
    98145
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GVS TM, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 28, 2026
    Initiation Date
    November 3, 2025
    Classification Date
    January 22, 2026
    Address
    1630 W Industrial Park St, Covina, CA, 91722-3419, United States

    Description

    SQ40S Blood Transfusion Filter

    Reason

    Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

    Code Info

    Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142

    Distribution

    U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MA

    Quantity

    2,720 filters