FDA Medical Device Recalls (openFDA)
Handicare USA, Inc.: ReTurn 7500/7500 Aid, transfer
- Recall number
- Z-0303-2017
- Recalling firm
- Handicare USA, Inc.
- Product
- ReTurn 7500/7500 Aid, transfer
- Status
- Terminated
- Initiated
- 2014-04-15
- Posted
- not on file
- Terminated
- 2016-12-13
- Reason
- During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder.
- Root cause
- Nonconforming Material/Component
- Action
- Handicare sent a Field Safety notice dated April 21, 2014, to all affected customers. The notification instructed customers to examine the affected ReTurn units for signs of wear and to complete the response form that was mailed with the customer notification letter indicating whether additional parts were required to complete the field correction. For further questions, please call (717) 733-1444.
- Quantity
- 29 units , plus 47 wing handles were shipped as spare parts
- Distribution
- US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME
- Lot, serial or model codes
- Model # 7400, 7500 and 7322 (spare part) Serial # 373317697270501334, 373317697270501430, 073317697400500012, 073317697400500057
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IKX
- Firm FEI
- 3007802293
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
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