Handicare Recalls EVA Floor Lifts Due to Potential Joint Failure
Handicare AB is recalling 997 EVA Floor Lifts (Models 400, 450, 600) in the US and Mexico because abnormal use could cause the liftarm joint to break, posing an injury risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Handicare AB is recalling 997 units of EVA Floor Lifts, specifically Model Numbers 400, 450, and 600. These devices were distributed in the United States and Mexico.
The recall was initiated after customer feedback and internal suspicion indicated that abnormal use of the lifts could lead to deterioration in the joint of the liftarm. If the joint breaks, it could result in injury to the user.
All affected lifts must be checked and reported back to the manufacturer. Consumers should contact Handicare AB for instructions on how to proceed with the inspection and reporting process.
The recalled product
- Product
- EVA Floor Lifts, Model Numbers: 400, 450, 600
- Manufacturer
- Handicare AB
- Category
- Medical Device — Mobility Aids
- Hazard
- Affected units
- 997
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All affected models
Distribution
Distribution scope not specified by the agency.
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