🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: November 19, 2021 Ki Mobility Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ki Mobility Llc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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.

Distribution:

Distributed in: IL, IN, KY, MI, MO, NC, SC, TN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0467-2022