BEUDAMED
    FDA Enforcement Class II Ongoing

    XERF EFFECTOR 60. Electrosurgical unit.

    Recall: Z-0146-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0146-2026
    Event ID
    97620
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Lutronic Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2025
    Initiation Date
    September 4, 2025
    Classification Date
    October 14, 2025
    Address
    219 Sowon-Ro; Deogyang, Goyang, N/A, Korea (the Republic of)

    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.

    Code Info

    Model/Catalog Number: 1101210000, 1101210100, 1101210200; UDI: 08809447657752, SERIAL/LOT: MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, and MP60J25H01. Devices manufactured from 04/01/25 to 08/20/25.

    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