FDA Devices recall · Reported January 19, 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 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.
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
Ki Mobility Llc recalled Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wa… - a low-severity action.
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wa… was recalled by Ki Mobility Llc in January 19, 2022. Reason: The Instructions for Use provided with the device contained information intended for use of a mechanical whee…. Check the official notice for the remedy. Verify recall #Z-0467-2022 with the FDA Devices before acting.
The recall
Ki Mobility Llc issued this low-severity FDA Devices recall-The Instructions for Use provided with the device contained information intended for use of a mechanical whee….
- Low
- severity level
- 33 units
- affected scope
- Class III
- classification
- January 19, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0467-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0467-2022 |
| Date reported | January 19, 2022 |
| Date initiated | November 19, 2021 |
| Recalling firm | Ki Mobility Llc |
| Firm location | Stevens Point, WI |
| Affected scope | 33 units shipped with affected manuals |
| Distribution | Domestic: IL, IN, KY, MI, MO, NC, SC, and TN. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0467-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026