Z-0866-2012

Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric Rehab...

Name: Z-0866-2012 Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric Rehab...
Creator: Gunnell, Inc.
Published: 2011-11-01
License: https://open.fda.gov/license/

GUNNELL, Inc. / initiated 2011-11-01 / Terminated / root cause: design

FDA source

Gunnell, Inc. began a recall of Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric Rehab Tough & Tilt (BTNT) Product Usage: The purpose of... on 2011-11-01. The reason FDA records is "Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the Rehab Tough and Tilt...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0866-2012
Status: Terminated
Initiated: 2011-11-01
Posted: 2012-01-25
Terminated: 2013-08-29
Recalling firm: GUNNELL, Inc.
Product: Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric Rehab Tough & Tilt (BTNT) Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.
Product code: IOR Wheelchair, Mechanical
Reason for recall: Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the Rehab Tough and Tilt (TNT), Bariatric Rehab Tough and Tilt (BTNT), Rehab Recline and Mobility (RAM), Bariatric Rehab Recline and Mobility (BRAM), and Rehab Kidster.
Root cause tag: design
FDA root cause: Component design/selection
Action: Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to [email protected]. or call 1-800-551-0055, attention Andy Evancho.
Quantity in commerce: 10 units
Distribution: Worldwide Distribution - USA (nationwide) nad the countries of: Australia and Canada
Product codes and lots: Serial numbers: 32031-0504, 32280-0704, 34402-0207, 33383-01 06, 33304-1205, 33409-0106, 33436-0206, 33515-0306, 34712-0607, 35899-0209

Product code IOR

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)