BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-001

    Recall: Z-0367-2025 · Reported November 20, 2024

    Enforcement

    Recall Number
    Z-0367-2025
    Event ID
    95502
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2024
    Initiation Date
    October 4, 2024
    Classification Date
    November 13, 2024
    Address
    1941 Stryker Way, N/A, Portage, MI, 49002-9711, United States

    Description

    Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-001

    Reason

    There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

    Code Info

    GTIN: 07613327117219 Lot Number: 64117291

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.

    Quantity

    2,620 eaches