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U.S. Department of Health and Human Services

Class 2 Device Recall Molift

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 Class 2 Device Recall Moliftsee related information
Date Initiated by FirmNovember 17, 2025
Date PostedFebruary 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1309-2026
Recall Event ID 98087
Product Classification Lift, patient, non-ac-powered - Product Code FSA
ProductBrand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.
Code Information (1) Model/Catalog Number: M1501; UDI-DI: TBD; Serial Numbers: 601005, 601002, 611506, 621101, 621106, 621104, 621105, 621102, 611505, 611504, 611503, 611502, 611501, 601008, 611507, 601007, 601006, 601001, 621103, 601003, 601004; (2) Model/Catalog Number: M1502; UDI-DI: TBD; Serial Numbers: 611409, 611408, 611407, 611406, 611405, 611404, 611403, 611402, 611401, 611412, 611411, 611410; (3) Model/Catalog Number: M1504; UDI-DI: TBD; Serial Numbers: 600902, 600901, 611303, 611302, 611301; (4) Model/Catalog Number: M15050; UDI-DI: TBD; Serial Numbers: 586003, 586001, 585905, 585903, 585902, 585901, 598605, 586101, 585904, 603602, 591401, 586002, 586006, 586005, 586004, 598608, 598607, 585906, 591601, 598606, 598604, 598602, 598601, 596501, 603601, 598609, 598603; (5) Model/Catalog Number: M15151; UDI-DI: TBD; Serial Numbers: 599703, 599702, 599701; (6) Model/Catalog Number: M15001; UDI-DI: TBD; Serial Numbers: 584401; (7) Model/Catalog Number: M15002; UDI-DI: TBD; Serial Numbers: 591501, 591502;
FEI Number 3004137175
Recalling Firm/
Manufacturer		 ETAC A/S
Parallelvej 3
Gedved Denmark
For Additional Information ContactSampavi Rajkumar
0045-796-85833
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Component design/selection
ActionOn November 17, 2025 customers were notified vis a phone call. Notifying them that they will receive an email with the Field Safety Notice and Response Form. The customers were emailed Field Safety Notice letters on or around November 20, 2025. Corrective action: To reduce the risk of further incidents, replacement units are offered for all potentially affected products. Continued use is safe as long as the lifting bar can move freely and remains vertical during the lifting cycle with or without load. If this is not the case, or if there is any doubt about the product s functionality, the unit must be taken out of service immediately. The components in the defective units (Mover 205 and Mover 300) will gradually be replaced in the coming months. The affected lifting bars will likewise be replaced.
Quantity in Commerce71
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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