FDA Device recall Z-1815-2026
React Health PHOENIX 5L Oxygen Concentrator
- FDA Device
- Class II
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class II recall of React Health PHOENIX 5L Oxygen Concentrator by 3b Medical, citing devices which did not meet internal quality specifications were inadvertently distributed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1815-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-04 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | 3b Medical |
| Distribution | US |
Product
React Health PHOENIX 5L Oxygen Concentrator
Reason
Devices which did not meet internal quality specifications were inadvertently distributed.
Identifiers
| code_info | UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1815-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.