Severity
Low
LowClass IIITerminated
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 FDA Devices action (record #Z-0467-2022) was formally reported on January 19, 2022, with the manufacturer initiating the action on November 19, 2021. It is classified under Low severity (Class III), with a current status of Terminated. Ki Mobility Llc is listed as the recalling firm, operating out of Stevens Point, WI. Federal records list the affected scope as 33 units shipped with affected manuals.
The documented reason for this recall is: The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. Distribution data in the federal record shows the product reached: Domestic: IL, IN, KY, MI, MO, NC, SC, and TN.. Distribution scope 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 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.
Affected scope
33 units shipped with affected manuals
Related Recalls
6
6 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ki Mobility Llc. Units affected: 33 units shipped with affected manuals.
Why was this product recalled? ▼
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 19, 2022. Severity: Low. Recall number: Z-0467-2022.
Where was the recalled product distributed? ▼
Distribution: Domestic: IL, IN, KY, MI, MO, NC, SC, and TN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0467-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 19, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.