Class II — Sunrise Medical (US) LLC
| Recalling firm | Sunrise Medical International Inc. |
|---|---|
| Registered facility | SUNRISE MEDICAL INTERNATIONAL INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame. |
| Product | Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position. |
| Quantity | 12,142 devices in US, 1,710 devices internationally. |
| Distribution | US and Mexico, Japan, Chile, Kuwait, Columbia, Hong Kong, China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles, British Virgin Islands, |
| Initiated | 2016-07-01 |
| Classified | 2016-07-25 |
| Terminated | 2017-09-11 |
| Recall number | Z-2290-2016 |
| Initiation | Voluntary: 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-2290-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74596/
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