Z-0809-2013Class II

Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt...

Name: Z-0809-2013 Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt...
Creator: Chenica Inc.
Published: 2013-01-18
License: https://open.fda.gov/license/

GUNNELL, Inc. / initiated 2013-01-18 / Terminated / root cause: labeling and UDI

FDA source

CHENICA INC. began a recall of Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster... on 2013-01-18. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0809-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-18
Posted: 2013-02-13
Terminated: 2014-04-15
Recalling firm: GUNNELL, 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.
Product code: IOR Wheelchair, Mechanical
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0809-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0809-2013	Class II	Completed	Voluntary: Firm initiated	2013-02-20	2013-02-13

Product code IOR

K111636Class IRehab Tnt, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab Tnt and Rehab RamGunnell, Inc. / cleared 2012-04-03

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)