Ki Mobility — Class III medical device recall Z-0467-2022

Terminated recall by Ki Mobility Llc, reported 2022-01-19, distributed in IL, IN, KY, MI, MO, NC, SC, TN. The Instructions for Use provided with the device contained information intended for use of a mechanical wheel

Recall number	`Z-0467-2022`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Ki Mobility Llc, Stevens Point, WI, United States
Recall initiated	2021-11-19
Classified	2022-01-07
Reported by FDA	2022-01-19
Terminated	2022-10-31
Distributed	IL, IN, KY, MI, MO, NC, SC, TN
Quantity	33 units
UPC / GTIN / UDI-DI	`00850013379231`
Serial numbers	`TYK0000500`, `TYK0000501`, `TYK0000502`, `TYK0000503`, `TYK0000504`, `TYK0000505`, `TYK0000506`, `TYK0000507`, `TYK0000508`, `TYK0000509`, `TYK0000510`, `TYK0000511`, `TYK0000512`, `TYK0000513`, `TYK0000514`, `TYK0000515`, `TYK0000516`, `TYK0000517`, `TYK0000518`, `TYK0000519`, `TYK0000520`, `TYK0000521`, `TYK0000522`, `TYK0000524`, `TYK0000525` and 8 more

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 for recall

The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0467-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.