CLASS II Device recall · Reported 15 Jan 2014 · FDA Enforcement Report
Tracer IV wheelchairs, Heavy duty manual wheel chair recalled
Invacare is recalling Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width weight capacity, distributed in Michigan. The recall was initiated on 16 Apr 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0634-2014
- FDA event ID
- 67134
- Recalling firm
- Invacare, Elyria, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2012
- FDA classified
- 7 Jan 2014
- Reported
- 15 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 16 Apr 2012 | Recall initiated by company | |
| 7 Jan 2014 | Classified by FDA | +631 days |
| 15 Jan 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Distribution: Michigan only.
Questions about this recall
Why was it recalled?
The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
Which lots are affected?
Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722.
Where was it sold?
US Distribution: Michigan only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS II | Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Quantum Rehab Quantum 4Front 2HD recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge 2.0 (ilevel) recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |