BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;

    Recall: Z-1308-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1308-2026
    Event ID
    98087
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ETAC A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 11, 2026
    Initiation Date
    November 17, 2025
    Classification Date
    February 5, 2026
    Address
    Parallelvej 3, N/A, Gedved, N/A, N/A, Denmark

    Description

    Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;

    Reason

    A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.

    Code Info

    (1) Model/Catalog Number: M14000; UDI-DI: 05707995032270; Serial Numbers: 616606, 616604, 591003, 591002, 590906, 590901, 590904, 590903, 590902, 591001, 604101, 604005, 591703, 591007, 591006, 591005, 591004, 615105, 615104, 615103, 615102, 615101, 604004, 604003, 604002, 604001, 614202, 614201, 591702, 591701, 616603, 615106, 590905; (2) Model/Catalog Number: M1401; UDI-DI: 05707995032270; Serial Numbers: 593302, 593301, 593303, 612507, 612506, 612508, 612505, 612503, 620702, 612504, 612502, 612501, 593304, 593305, 620703, 620701; (3) Model/Catalog Number: M1402; UDI-DI: 05707995032270; Serial Numbers: 612601; (4) Model/Catalog Number: M14050; UDI-DI: 05707995032270; Serial Numbers: 590801, 596701, 585701, 584501, 591801, 604405, 604406, 604402, 604404, 604403, 604401, 604303, 604302, 604301; (5) Model/Catalog Number: M14150; UDI-DI: 05707995032270; Serial Numbers: 585811, 585810, 585809, 585808, 585806, 585805, 585804, 585803, 585801, 596604, 596603, 596602, 596601, 596611, 596610, 596609, 596608, 596607, 596606, 596605, 585807, 585802; (6) Model/Catalog Number: M1402-01; UDI-DI: 05707995032270; Serial Numbers: 612701, 612703, 612702; (7) Model/Catalog Number: M14050-00; UDI-DI: 05707995032270; Serial Numbers: 584307; (8) Model/Catalog Number: M14001; UDI-DI: 05707995032270; Serial Numbers: 603501, 599801, 599802, 604202, 604201;

    Distribution

    Worldwide - US Nationwide distribution in the state of PA and the countries of Australia, Czech Republic, Finland, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Poland, Qatar Spain, Sweden, Switzerland, UK.

    Quantity

    95 units