RegWardenFDA facility compliance records
Company

Handicare USA, Inc.

4 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2014: 1 recalls; 2015: 1 recalls; 2017: 2 recalls1’141’15’162’17’18’19’20’21’22’23’24’25’26
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2017-11-03
    Premature strap wear and breakage at maximum weight conditions (625 lbs.).
  • Class IITerminated2017-09-08
    During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to s…
  • Class IITerminated2015-03-26
    Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
  • Class IITerminated2014-04-15
    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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Handicare USA, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10029966-handicare-usa-inc/

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