FDA-Device2026-02-11Class IIPROCESSING DEFECT

ETAC Molift 4-point sling bars recalled for bolt fracture risk during use

OTHERNationwide distributionMedical devices

What this means

The mounting bolt on ETAC Molift 4-point sling bars (models 1430116, 1430117, 1430115) can break during assembly or use due to material deformation at the joint. This can cause the lifting bar to lose proper function, affecting the safety and reliability of the mobile hoist. About 25 units have been distributed worldwide.

Stop using affected Molift 4-point sling bars immediately
Check if you have model 1430116, 1430117, or 1430115
Contact ETAC A/S or your distributor for instructions on repair or replacement

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

25 units

Manufactured in

Parallelvej 3, N/A, Gedved, N/A, Denmark

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1311-2026

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