Z-1943-2020Class II

EVA Floor Lifts, Model Numbers: 400, 450, 600

Name: Z-1943-2020 EVA Floor Lifts, Model Numbers: 400, 450, 600
Creator: Handicare AB
Published: 2016-06-15
License: https://open.fda.gov/license/

Direct Healthcare Group Sverige AB / initiated 2016-06-15 / Open, Classified / root cause: design

FDA source

Handicare AB began a recall of EVA Floor Lifts, Model Numbers: 400, 450, 600 on 2016-06-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1943-2020
Classification: Class II
Status: Open, Classified
Initiated: 2016-06-15
Posted: 2020-05-09
Recalling firm: Direct Healthcare Group Sverige AB
Product: EVA Floor Lifts, Model Numbers: 400, 450, 600
Product code: FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag: design
FDA 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 in commerce: 997 units
Distribution: US and Mexico
Product codes and lots: All affected models

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1943-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1943-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)