FDA Medical Device Recalls (openFDA)
Invacare Corporation: Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
- Recall number
- Z-0634-2014
- Recalling firm
- Invacare Corporation
- Product
- Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
- Status
- Terminated
- Initiated
- 2012-04-16
- Posted
- 2014-01-08
- Terminated
- 2014-01-10
- Reason
- The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
- Root cause
- Component design/selection
- Action
- The firm, Invacare, sent a memo dated December 4, 2013 to their customer. The memo described the product, problem, and actions to be taken . On February 8, 2012 representatives from the recalling firm visited the customer to investigate the complaint. The wheelchairs were returned and destroyed. If you have any question, please call 440-329-6875 or email: ssaigal@invacare.com.
- Quantity
- 227 Wheelchairs
- Distribution
- US Distribution: Michigan only.
- Lot, serial or model codes
- Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IOR
- Firm FEI
- 3002889431
- Firm city
- Elyria
- Firm state
- OH
- 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