FDAFDA · Food and drugs·Recall number Z-1815-2026
React Health PHOENIX 5L Oxygen Concentrator
Published April 22, 2026 · Recall initiated: February 4, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Devices which did not meet internal quality specifications were inadvertently distributed.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- 3B Medical, Inc.
- Distributor
- US Nationwide distribution in the state of NY.
- Lot
- UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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