PURE OXYGEN CONCENTRATOR — Class II medical device recall Z-0407-2018
Terminated recall by Inovo, Inc, reported 2018-01-31. Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggr
| Recall number | Z-0407-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inovo, Inc, Lehigh Acres, FL, United States |
| Recall initiated | 2017-10-09 |
| Classified | 2018-01-24 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2023-09-15 |
| Quantity | 13,140 units |
| UPC / GTIN / UDI-DI | 00814470020006, 00814470020013 |
| Model numbers | CH5000, CH5000S |
Product
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Reason for recall
Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
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-0407-2018. 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.