FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809600 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Fixed Height. item #MDS809650 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Fixed Height.
- Recall number
- Z-1770-2008
- Recalling firm
- Medline Industries Inc
- Product
- Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809600 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Fixed Height. item #MDS809650 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Fixed Height.
- Status
- Terminated
- Initiated
- 2008-03-31
- Posted
- 2008-08-19
- Terminated
- 2010-05-11
- Reason
- Fingers can get injured. There is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. Injuries can be severe from fractures to severing.
- Root cause
- Component design/selection
- Action
- A Voluntary Field Correction letter dated 3/31/08 was issued to customers. The letter informed them of reports of users catching their fingers under the seat bars, which are identified on the chair with warning stickers. The customers were requested to change the backrest with the enclosed replacement upholstery kit, properly dispose of the old back rest, and place the enclosed cautionary tags on both sides of the chair seat. Instructions for installation of the upholstery and cautionary tags were included, as was a sheet entitled "How to Open a Wheelchair" which gives step by step instructions with illustrations for opening the wheelchair, as well as the warning "CAUTION KEEP YOUR FINGERS ON TOP OF THE UPHOLSTERY AT ALL TIMES. DO NOT PLACE YOUR FINGERS ON THE SIDES OR BOTTOM OF THE CHAIR SEAT." The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the serial numbers of chairs corrected. Any questions were directed to 800-633-5463, extension 5349, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall.
- Quantity
- 430 wheelchairs
- Distribution
- Class II Recall - Worldwide Distribution --- including USA and Canada.
- Lot, serial or model codes
- Item numbers MDS809600 and MDS809650; all wheelchairs purchased between 12/01/2005 and 08/31/2007
- 510(k) numbers
- ["K051302"]
- PMA numbers
- not on file
- Product code
- IOR
- Firm FEI
- 1417592
- Firm city
- Mundelein
- Firm state
- IL
- 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