ETAC A/S: Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 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.

Recall number

Z-1311-2026

Recalling firm

ETAC A/S

Product

Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 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.

Status

Open, Classified

Initiated

2025-11-17

Posted

2026-02-05

Terminated

not on file

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.

Root cause

Component design/selection

Action

On 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

25 units

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.

Lot, serial or model codes

(1) Model/Catalog Number: 1430116; UDI-DI: TBD; (2) Model/Catalog Number: 1430117; UDI-DI: TBD; (3) Model/Catalog Number: 1430115; UDI-DI: TBD;

510(k) numbers

not on file

PMA numbers

not on file

Product code

FSA

Firm FEI

3004137175

Firm city

Gedved

Firm state

not on file

Firm country

Denmark

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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