BEUDAMED
    FDA Recall Open, Classified

    Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip

    Recall: Z-2170-2025 · Initiated June 18, 2025

    Recall

    Recall Number
    Z-2170-2025
    Event Number
    97039
    Firm
    Stryker Corporation
    FEI Number
    2936485
    Product Code
    GCJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 18, 2025
    Posted
    July 23, 2025
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without 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.

    Action

    On June 18, 2025, Stryker issued a "Urgent: Medical Device Recall" Notification to affected consignees. On November 20, 2025, Stryker initiated a recall notification update. Stryker ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product. 3. If affected product is found, quarantine and initiate the return process for affected units. 3a. Please complete Business Reply Form or use QR Code on Attachment A to return product. 4. If affected product is NOT found: 4a. Please complete Business Reply Form or use QR Code on Attachment A. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required.

    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.