BEUDAMED
    FDA Recall Open, Classified

    XERF EFFECTOR 60. Electrosurgical unit.

    Recall: Z-0146-2026 · Initiated September 4, 2025

    Recall

    Recall Number
    Z-0146-2026
    Event Number
    97620
    Firm
    Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (the Republic of)
    FEI Number
    3004483538
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    September 4, 2025
    Posted
    October 14, 2025

    Description

    XERF EFFECTOR 60. Electrosurgical unit.

    Reason

    Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

    Action

    An URGENT-Field Safety Corrective Action - XERF Tips notification dated 9/4/25 was mailed to consignees notifying them of this recall. Consignees are instructed to immediately stop use of affected devices and to return all units utilizing the provided shipping label. Consignees with any questions can contact Customer Service at 1-800-886-2966 or by email at [email protected].

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY, PA, TX, and UT. The countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

    Quantity

    7,490 units