FDA Medical Device Recalls (openFDA)
CHENICA INC.: Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.
- Recall number
- Z-0809-2013
- Recalling firm
- CHENICA INC.
- Product
- Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.
- Status
- Terminated
- Initiated
- 2013-01-18
- Posted
- 2013-02-13
- Terminated
- 2014-04-15
- Reason
- The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW).
- Root cause
- Labeling False and Misleading
- Action
- Gunnell Inc. sent a "RE: URGENT MEDICAL DEVICE CORRECTION/RECALL" letter dated January 18, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm 1-800-551-0055 for questions relating to this letter.
- Quantity
- 53
- Distribution
- Nationwide Distribution-including the states of Florida, Michigan, South Carolina, California, Texas, Maryland, New York, Tennessee, Virginia, Illinois, Ohio, Massachusetts, Arizona and Washington.
- Lot, serial or model codes
- Serial Numbers: 36977-1210, 37194-0312, 37455-1111, 37606-0312, 36988-1210, 37220-0511, 37484-1111, 37614-0312, 36999-1210, 37234-0511, 37495-1211, 37628-0312, 37000-1210, 37273-0611, 37497-0711, 37632-0312, 37003-1210, 37305-0711, 37515-1211, 37633-0312, 37014-1210, 37307-0711, 37520-1211, 37636-0312, 37061-0211, 37333-0711, 37521-1211, 37637-0411, 37067-0111, 37348-0811, 37523-1211, 37675-0412, 37094-0211, 37374-0911, 37537-0112, 37681-0412, 37114-0211, 37393-0911, 37555-0112, 37286-0511, 37122-0211, 37394-0911, 37576-0212, 37296-0611, 37137-0311, 37440-1011, 37584-0212, 37141-0311, 37448-1011, 37594-0212, 37185-0311, 37449-1011, 37601-0312.
- 510(k) numbers
- ["K111636"]
- PMA numbers
- not on file
- Product code
- IOR
- Firm FEI
- 3009255757
- Firm city
- Vassar
- Firm state
- MI
- Firm country
- not on file
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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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