Lulea, N/A, Sweden
Handicare AB recalls
2 recalls recorded since 2018, most recently on 21 August 2020. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 21 August 2020
- Terminated
- 30 January 2023
- Reason
- Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, IL, MD, MI, MN, NH, NJ, NY, ON, PA, TX, VA, WA, WI and the countries of Australia, Belgium, Canada, Chile, Denmark, Finland, Germany, Iceland, Ireland, Israel, Japan, Lithuania/ Lathvia, Malaysia, New Zealand, Norway,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0096-2021
- SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving ph
Ongoing Class II Medical devices
- Recall started
- 15 June 2016
- Reason
- After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer.
- Distribution
- US and Mexico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1943-2020
- EVA Floor Lifts, Model Numbers: 400, 450, 600
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.