Z-0303-2017Class II

ReTurn 7500/7500 Aid, transfer

Name: Z-0303-2017 ReTurn 7500/7500 Aid, transfer
Creator: Handicare USA, Inc.
Published: 2014-04-15
License: https://open.fda.gov/license/

Handicare USA, Inc. / initiated 2014-04-15 / Terminated / root cause: manufacturing process

FDA source

Handicare USA, Inc. began a recall of ReTurn 7500/7500 Aid, transfer on 2014-04-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0303-2017
Classification: Class II
Status: Terminated
Initiated: 2014-04-15
Posted: 2016-10-24
Terminated: 2016-12-13
Recalling firm: Handicare USA, Inc.
Product: ReTurn 7500/7500 Aid, transfer
Product code: IKX Aid, Transfer
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Model # 7400, 7500 and 7322 (spare part) Serial # 373317697270501334, 373317697270501430, 073317697400500012, 073317697400500057

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0303-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0303-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-24

Product code IKX

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)