FDA Device recall Z-0467-2022
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be u…
- FDA Device
- Class III
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class III recall of Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be u… by Ki Mobility, citing the Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0467-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-11-19 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ki Mobility |
| Distribution | IL, IN, KY, MI, MO, NC, SC, TN |
Product
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.
Reason
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
Identifiers
| code_info | Model No.: TYK; Serial No: TYK0000500, TYK0000501, TYK0000502, TYK0000503, TYK0000504, TYK0000506, TYK0000505, TYK00005…Model No.: TYK; Serial No: TYK0000500, TYK0000501, TYK0000502, TYK0000503, TYK0000504, TYK0000506, TYK0000505, TYK0000507, TYK0000508, TYK0000509, TYK0000510, TYK0000512, TYK0000511, TYK0000513, TYK0000517, TYK0000520, TYK0000518, TYK0000514, TYK0000515, TYK0000519, TYK0000516, TYK0000521, TYK0000522, TYK0000525, TYK0000524, TYK0000526, TYK0000527, TYK0000528, TYK0000530, TYK0000529, TYK0000531, TYK0000532, TYK0000534; UDI: (01)00850013379231(11)2021-04-05(21)TYK0000500, (01)00850013379231(11)2021-04-12(21)TYK0000501, (01)00850013379231(11)2021-04-13(21)TYK0000502, (01)00850013379231(11)2021-04-19(21)TYK0000503, (01)00850013379231(11)2021-04-29(21)TYK0000504, (01)00850013379231(11)2021-06-11(21)TYK0000505, (01)00850013379231(11)2021-06-11(21)TYK0000507, (01)00850013379231(11)2021-06-11(21)TYK0000508, (01)00850013379231(11)2021-07-08(21)TYK0000509,(01)00850013379231(11)2021-07-08(21)TYK0000510, (01)00850013379231(11)2021-06-11(21)TYK0000512, (01)00850013379231(11)2021-07-14(21)TYK000051 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0467-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.