CLASS II ONGOING Device recall · Reported 20 May 2020 · FDA Enforcement Report
EVA Floor Lifts recalled by Handicare AB
Handicare AB is recalling EVA Floor Lifts. The recall was initiated on 15 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1943-2020
- FDA event ID
- 85362
- Recalling firm
- Handicare AB, Lulea, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jun 2016
- FDA classified
- 8 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 15 Jun 2016 | Recall initiated by company | |
| 8 May 2020 | Classified by FDA | +1423 days |
| 20 May 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
EVA Floor Lifts, Model Numbers: 400, 450, 600
Where it was distributed
US and Mexico
Questions about this recall
Is EVA Floor Lifts recalled?
Yes. Handicare AB recalled EVA Floor Lifts on 15 Jun 2016. The recall is Class II and its status is Ongoing. Recall number Z-1943-2020.
Why was it recalled?
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.
Which lots are affected?
All affected models
Where was it sold?
US and Mexico
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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