BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device

    Recall: Z-0467-2026 · Reported November 19, 2025

    Enforcement

    Recall Number
    Z-0467-2026
    Event ID
    97822
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 19, 2025
    Initiation Date
    October 1, 2025
    Classification Date
    November 7, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device

    Reason

    Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

    Code Info

    UDI/DI 20193489189688 (each), 10193489189681 (case), All Lots

    Distribution

    US Nationwide distribution.

    Quantity

    4226 units