FDA recall Z-1815-2026
3B Medical, Inc. · Class II · device
Product
React Health PHOENIX 5L Oxygen Concentrator
Reason for recall
Devices which did not meet internal quality specifications were inadvertently distributed.
Distribution
US Nationwide distribution in the state of NY.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-02-04
- Report date
- 2026-04-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Dublin, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1815-2026