FDA Medical Device Recalls (openFDA)
Tung Keng Enterprise Co., Ltd.: The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. The product is distributed by the Invacare Corporation.
- Recall number
- Z-0522-06
- Recalling firm
- Tung Keng Enterprise Co., Ltd.
- Product
- The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. The product is distributed by the Invacare Corporation.
- Status
- Terminated
- Initiated
- 2005-11-01
- Posted
- 2006-02-16
- Terminated
- 2012-05-08
- Reason
- The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.
- Root cause
- Other
- Action
- The recalling firm sent field correction instructions to their customers on or about 11/1/05.
- Quantity
- 8,213 total devices
- Distribution
- The product was distributed to OHL/Invacare, Rancho Technology Park Bldg. B 8950, Rancho Cucamonga, CA 91730; OHL/Invacare, 1100 Whitaker Road, Plainfield, IN 46168; Invacare Corporation, 39400 Taylor Parkway North Ridgeville, OH 44039; and Invacare, Dallas Texas Distribution Center, 3460 South Watson Rd., Arlington, TX 76014.
- Lot, serial or model codes
- All serial numbers 04H86001 to 05A468246.
- 510(k) numbers
- ["K033240"]
- PMA numbers
- not on file
- Product code
- INI
- Firm FEI
- 3002667030
- Firm city
- Hsiang Taichung County
- Firm state
- not on file
- Firm country
- Taiwan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28