Handicare ReTurn 7500 Transfer Aids Recalled for Ladder Fatigue Risk
Handicare USA is recalling ReTurn 7500 transfer aids because a wing handle defect may cause mechanical fatigue in the ladder.
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 structural defect in a medical device that may lead to mechanical fatigue and potential failure, posing a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Handicare USA, Inc. is recalling specific units of the ReTurn 7500/7500 Aid, transfer. The recall involves 29 units and 47 wing handles shipped as spare parts. These products were distributed in the United States to New York, New Jersey, Nevada, Nebraska, Illinois, Connecticut, Pennsylvania, and Maine.
The recall is due to a defect in the wing handle used during the period of April 2009 to May 2011. The screw and handle may slide apart after repeated tightening, causing play in the ladder attachment. This results in high load at the attachment holes, which may eventually cause mechanical fatigue in the ladder material.
Consumers should stop using the affected transfer aids and contact Handicare USA for instructions on repair or replacement. The affected models are 7400, 7500, and 7322 (spare part).
The recalled product
- Product
- ReTurn 7500/7500 Aid, transfer
- Manufacturer
- Handicare USA, Inc.
- Category
- Medical Device — Mobility Aids
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 (5)
- Model # 7400
- 7500 and 7322 (spare part) Serial # 373317697270501334
- 373317697270501430
- 073317697400500012
- 073317697400500057
Distribution
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