CLASS II Device recall · Reported 9 Dec 2020 · FDA Enforcement Report
PerfectO2 V Oxygen Concentrator- intended for patients recalled
Invacare is recalling PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders, distributed nationwide in the US. The recall was initiated on 30 Oct 2020 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-0514-2021
- FDA event ID
- 86604
- Recalling firm
- Invacare, Elyria, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Oct 2020
- FDA classified
- 1 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- CPAP & Ventilators
Timeline
| 30 Oct 2020 | Recall initiated by company | |
| 1 Dec 2020 | Classified by FDA | +32 days |
| 9 Dec 2020 | 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
Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5
Where it was distributed
Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands
Questions about this recall
Why was it recalled?
Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.
Which lots are affected?
Model numbers: IRC5PO2V from Serial # 14HF039890 to 18JF007415; IRC5PO2VC from Serial # 14IF004028 to 18JF028633; IRC5PO2VAW from serial #17HF030338-18IF018522; IRC5PO2VAWL2 from serial # 18BF007341-18IF024451; IRC5PO2VAWL3 from serial # 17JF002563-19AF008559; IRC5PO2VAWL5 from serial # 18EF003466-18EF003544. DI Number: 00841447100249
Where was it sold?
Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands
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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