Z-0467-2022Class III

Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually...

Name: Z-0467-2022 Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually...
Creator: Ki Mobility Llc
Published: 2021-11-19
License: https://open.fda.gov/license/

Ki Mobility / initiated 2021-11-19 / Terminated / root cause: manufacturing process

FDA source

Ki Mobility Llc began a 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 used for medical... on 2021-11-19. FDA classified it as Class III and gives the reason as "The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0467-2022
Classification: Class III
Status: Terminated
Initiated: 2021-11-19
Posted: 2022-01-07
Terminated: 2022-10-31
Recalling firm: Ki Mobility
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.
Product code: INM Chair, With Casters
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm distributed a Medical Device Correction Notice dated 12/07/2021 by first class mail to consignees. The notificaiton identified the reason for recall as the Owner's Manual/Instructions for Use for the Little Wave Tyke contained information intended for a mechanical wheelchair, not a mechanical chair with casters. Customers were instructed to distribute the provided updated Little Wave Tyke Owner's Manual/Instructions for Use (DCN0569.2) to end users, and if available request that customers destroy or dispose of the previous versions of the manual (DCN0569.0 and DCN0569.1). The updated manual is available in print or on the company's website (kimobility.com). Customers with any questions are asked to contact the firm by email at [email protected], or by phone at (715)254-0991 or (800)981-1540.
Quantity in commerce: 33 units shipped with affected manuals
Distribution: Domestic: IL, IN, KY, MI, MO, NC, SC, and TN.
Product codes and lots: 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)TYK0000511, (01)00850013379231(11)2021-08-06(21)TYK0000513, (01)00850013379231(11)2021-08-06(21)TYK0000517, (01)00850013379231(11)2021-08-06(21)TYK0000520, (01)00850013379231(11)2021-08-06(21)TYK0000518, (01)00850013379231(11)2021-08-06(21)TYK0000514, (01)00850013379231(11)2021-08-06(21)TYK0000515, (01)00850013379231(11)2021-08-06(21)TYK0000519, (01)00850013379231(11)2021-08-06(21)TYK0000516, (01)00850013379231(11)2021-08-16(21)TYK0000521, (01)00850013379231(11)2021-09-02(21)TYK0000522, (01)00850013379231(11)2021-09-20(21)TYK0000525, (01)00850013379231(11)2021-09-20(21)TYK0000524, (01)00850013379231(11)2021-10-04(21)TYK0000526, (01)00850013379231(11)2021-10-04(21)TYK0000527, (01)00850013379231(11)2021-10-12(21)TYK0000528, (01)00850013379231(11)2021-10-29(21)TYK0000530, (01)00850013379231(11)2021-10-29(21)TYK0000529, (01)00850013379231(11)2021-11-16(21)TYK0000531, (01)00850013379231(11)2021-11-17(21)TYK0000532, (01)00850013379231(11)2021-11-17(21)TYK0000534.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0467-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0467-2022	Class III	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-07

Product code INM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)