Agency classClass IIOur severity:Severe FDA (Devices)·Z-0514-2021·Announced 2020-12-09

Invacare PerfectO2 V Oxygen Concentrator Recalled for Fire and Explosion Risk

Invacare is recalling 384,767 PerfectO2 V oxygen concentrators worldwide due to a defect that may cause self-extinguishing fires or cap explosions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a hazard that can result in fires or cap explosions, which aligns with the rubric criteria for Severe severity involving significant injury or property damage reports.

Plain-English summary

Invacare Corporation is recalling 384,767 units of the PerfectO2 V Oxygen Concentrator. The affected devices are intended for patients with respiratory disorders requiring supplemental oxygen. The recall covers specific model numbers and serial number ranges distributed worldwide, including the United States, Canada, Australia, China, Germany, Guam, New Zealand, and the Northern Mariana Islands.

The recall is being issued because a breakdown of the sound abatement washer and metal-on-metal wear inside the Pressure Equalization (P.E.) valve assembly may lead to failure. This failure can result in self-extinguishing fires or cap explosions.

Consumers should stop using the affected devices immediately and contact Invacare Corporation for instructions on how to obtain a repair or replacement. The recall is classified as Class II by the FDA.

The recalled product

Product: 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
Manufacturer: Invacare Corporation
Category: Medical Device — Oxygen Concentrator
Hazard: fire
explosion
Affected units: 384,767

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Invacare Corporation

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