Recall Record

Gedved, N/A, Denmark

ETAC A/S recalls

1 recall recorded since 2018, most recently on 17 November 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
17 November 2025
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.
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.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1311-2026, Z-1308-2026, Z-1310-2026, Z-1309-2026

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.