# FDA recall Z-0467-2022

> **Ki Mobility Llc** · Class III · device recall initiated 2021-11-19.

## 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.

## Distribution

Domestic: IL, IN, KY, MI, MO, NC, SC, and TN.

## Key facts

- **Recall number:** Z-0467-2022
- **Recalling firm:** Ki Mobility Llc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-19
- **Report date:** 2022-01-19
- **Termination date:** 2022-10-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stevens Point, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0467-2022

## Citation

> AI Analytics. FDA recall Z-0467-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0467-2022. Source: US FDA. Licensed CC0.

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