Class II — Invacare Corporation
| Recalling firm | Invacare Corporation dba Invacare America |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 384,767 units |
| Distribution | Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands |
| Initiated | 2020-10-30 |
| Classified | 2020-12-01 |
| Terminated | 2024-12-31 |
| Recall number | Z-0514-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Invacare Corporation (Z-0514-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86604/
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