RegWardenFDA facility compliance records
Recall

Class II — Sunrise Medical (US) LLC

Recalling firmSunrise Medical International Inc.
Registered facilitySUNRISE MEDICAL INTERNATIONAL INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonQuickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
ProductZippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Quantity64 total wheelchairs, both models
DistributionWorldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.
Initiated2015-07-27
Classified2015-08-26
Terminated2015-12-10
Recall numberZ-2466-2015
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 — Sunrise Medical (US) LLC (Z-2466-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71829/

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