Reported Dec 9, 2020 · Terminated

Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental…

Invacare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Invacare Corporation · 1200 Taylor St · Elyria, OH · 44035-6248

Is this the product you have?

  • 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
Lot codes and dates

6 of 6 products

Products covered by this recall
#BarcodesProduct as published
1Model numbers: IRC5PO2V from Serial # 14HF039890 to 18JF007415
2IRC5PO2VC from Serial # 14IF004028 to 18JF028633
3IRC5PO2VAW from serial #17HF030338-18IF018522
4IRC5PO2VAWL2 from serial # 18BF007341-18IF024451
5IRC5PO2VAWL3 from serial # 17JF002563-19AF008559
600841447100249IRC5PO2VAWL5 from serial # 18EF003466-18EF003544. DI Number: 00841447100249
Amount recalled
384,767 units

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 31, 2024 · Data as of Sep 19, 7:00 PM UTC

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