FDAHealthFebruary 4, 2026
3B Medical, Inc. — React Health PHOENIX 5L Oxygen Concentrator
⚠️ Devices which did not meet internal quality specifications were inadvertently distributed.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 4, 2026
US Nationwide distribution in the state of NY.
What's affected?
- Product
- React Health PHOENIX 5L Oxygen Concentrator
- Brand
- 3B Medical, Inc.
- Lot code
- UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
Additional details
UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2 units.
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