BEUDAMED
    FDA Enforcement Class II Ongoing

    Flamingo Funnel Large, Model Number SQ20012-03

    Recall: Z-1926-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1926-2026
    Event ID
    98574
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SurgiSmoke Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2026
    Initiation Date
    March 16, 2026
    Classification Date
    April 22, 2026
    Address
    2300 Myrtle Ave Ste 200, N/A, Saint Paul, MN, 55114-1948, United States

    Description

    Flamingo Funnel Large, Model Number SQ20012-03

    Reason

    Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

    Code Info

    UDI-DI: 408882777851966; Lot 8264501

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.

    Quantity

    2505 units total