BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

    Recall: Z-2171-2025 · Reported July 30, 2025

    Enforcement

    Recall Number
    Z-2171-2025
    Event ID
    97039
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2025
    Initiation Date
    June 18, 2025
    Classification Date
    July 23, 2025
    Address
    5900 Optical Ct, N/A, San Jose, CA, 95138-1400, United States

    Description

    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

    Reason

    Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

    Code Info

    UDI: 07613327061369

    Distribution

    Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Philippines, Singapore, China, Japan, Canada, Korea.

    Quantity

    N/A