Recall Z-1308-2026— ETAC A/S
Class II · Ongoing
Class II FDA medical device recall by ETAC A/S, initiated 2025-11-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- ETAC A/S
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-17
- Firm location
- Gedved, N/A, Denmark
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.