React Health PHOENIX 5L Oxygen Concentrator — Class II medical device recall Z-1815-2026
Ongoing recall by 3B Medical, Inc., reported 2026-04-22, distributed nationwide. Devices which did not meet internal quality specifications were inadvertently distributed.
| Recall number | Z-1815-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3B Medical, Inc., Dublin, OH, United States |
| Recall initiated | 2026-02-04 |
| Classified | 2026-04-15 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Serial numbers | MZJ5S713971, MZJ5S714009 |
Product
React Health PHOENIX 5L Oxygen Concentrator
Reason for recall
Devices which did not meet internal quality specifications were inadvertently distributed.
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-1815-2026. 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.