Z-0634-2014Class II

Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed...

Name: Z-0634-2014 Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed...
Creator: Invacare Corporation
Published: 2012-04-16
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2012-04-16 / Terminated / root cause: design

FDA source

Invacare Corporation began a recall of Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to... on 2012-04-16. FDA classified it as Class II and gives the reason as "The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled". 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-0634-2014
Classification: Class II
Status: Terminated
Initiated: 2012-04-16
Posted: 2014-01-08
Terminated: 2014-01-10
Recalling firm: Invacare GmbH
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.
Product code: IOR Wheelchair, Mechanical
Reason for recall: 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 tag: design
FDA 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: [email protected].
Quantity in commerce: 227 Wheelchairs
Distribution: US Distribution: Michigan only.
Product codes and lots: Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0634-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0634-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-07

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)