ClearanceBrief
Recall Z-1310-2026 ยท FSA Lift, Patient, Non-Ac-Powered

ETAC A/S

Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 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

DateFeb 5, 2026 (initiated Nov 17, 2025)
StatusOpen, Classified
ReasonA 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 causeComponent 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
Quantity64 units
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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.