FDA Medical Device Recalls (openFDA)
Handicare AB: EVA Floor Lifts, Model Numbers: 400, 450, 600
- Recall number
- Z-1943-2020
- Recalling firm
- Handicare AB
- Product
- EVA Floor Lifts, Model Numbers: 400, 450, 600
- Status
- Open, Classified
- Initiated
- 2016-06-15
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- The firm notified their consignees on 06/15/2016 by email. The notice explained the issue of wear in the joint of the lift arm due to abnormal use in heavy loads and/or many lifts. The consignee was directed to inspect the lifts in order to identify gaps and/or cracks and to report to the local Handicare sales representative and to Handicare. On April 4, 2019, the firm sent a reminder notice on 04/04/2019
- Quantity
- 997 units
- Distribution
- US and Mexico
- Lot, serial or model codes
- All affected models
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSA
- Firm FEI
- 3009481053
- Firm city
- Lulea
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28