Invacare Perfecto 2 V Oxygen Concentrator The finished device is… — Class II medical device recall Z-0577-2015
Terminated recall by Invacare Corporation, reported 2014-12-17, distributed nationwide. It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to mig
| Recall number | Z-0577-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invacare Corporation, Elyria, OH, United States |
| Recall initiated | 2014-09-23 |
| Classified | 2014-12-09 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 5,963 |
| Model numbers | 1165099 |
Product
Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.
Reason for recall
It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.
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-0577-2015. 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.