RegWardenFDA facility compliance records
Recall

Class II — Handicare USA, Inc.

Recalling firmHandicare USA, Inc.
Registered facilityHandicare USA, Inc. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonDuring 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.
ProductReTurn 7500/7500 Aid, transfer
Quantity29 units , plus 47 wing handles were shipped as spare parts
DistributionUS Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME
Initiated2014-04-15
Classified2016-10-24
Terminated2016-12-13
Recall numberZ-0303-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Handicare USA, Inc. (Z-0303-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75404/

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