# FDA recall Z-0514-2021

> **Invacare Corporation** · Class II · device recall initiated 2020-10-30.

## 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

## 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.

## Distribution

Worldwide distribution.  US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands

## Key facts

- **Recall number:** Z-0514-2021
- **Recalling firm:** Invacare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-30
- **Report date:** 2020-12-09
- **Termination date:** 2024-12-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elyria, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0514-2021

## Citation

> AI Analytics. FDA recall Z-0514-2021. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-0514-2021. Source: US FDA. Licensed CC0.

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