BEUDAMED
    FDA Enforcement Class II Ongoing

    Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.

    Recall: Z-2413-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2413-2026
    Event ID
    98970
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2026
    Initiation Date
    May 12, 2026
    Classification Date
    June 11, 2026
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.

    Reason

    Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.

    Code Info

    GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029

    Distribution

    US Nationwide distribution.

    Quantity

    9750 units