[pending] React Health PHOENIX 5L Oxygen Concentrator
Pending LLM rewrite. Source: FDA_DEVICE Z-1815-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Devices which did not meet internal quality specifications were inadvertently distributed.
The recalled product
- Product
- React Health PHOENIX 5L Oxygen Concentrator
- Manufacturer
- 3B Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI 06934726614439-250623-MZJ5S713971
- Serial Number MZJ5S713971
- UDI 06934726614439-250623-MZJ5S714009
- Serial Number MZJ5S714009
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27