Invacare PerfectO2 V Oxygen Concentrator- intended for patients with… — Class II medical device recall Z-0514-2021
Terminated recall by Invacare Corporation, reported 2020-12-09, distributed nationwide. Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve
| Recall number | Z-0514-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invacare Corporation, Elyria, OH, United States |
| Recall initiated | 2020-10-30 |
| Classified | 2020-12-01 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2024-12-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, NZ |
| Quantity | 384,767 units |
| UPC / GTIN / UDI-DI | 00841447100249 |
| Serial numbers | 00841447100249, 14HF039890, 14IF004028, 17HF030338-18IF018522, 17JF002563-19AF008559, 18BF007341-18IF024451, 18EF003466-18EF003544, 18JF007415, 18JF028633, IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL5, IRC5PO2VC |
| Model numbers | IRC5PO2V |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0514-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.