FDA Medical Device Recalls (openFDA)
Gunnell, Inc.: 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.
- Recall number
- Z-0866-2012
- 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.
- Status
- Terminated
- Initiated
- 2011-11-01
- Posted
- 2012-01-25
- Terminated
- 2013-08-29
- Reason
- 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
- 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 andy.evancho@gunnell-inc.com. or call 1-800-551-0055, attention Andy Evancho.
- Quantity
- 10 units
- Distribution
- Worldwide Distribution - USA (nationwide) nad the countries of: Australia and Canada
- Lot, serial or model codes
- Serial numbers: 32031-0504, 32280-0704, 34402-0207, 33383-01 06, 33304-1205, 33409-0106, 33436-0206, 33515-0306, 34712-0607, 35899-0209
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IOR
- Firm FEI
- 3009255757
- Firm city
- Millington
- 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
- 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