Recall Z-1815-2026
3B Medical, Inc. · initiated February 4, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
React Health PHOENIX 5L Oxygen Concentrator
Codes / lots: UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
Reason for recall
Devices which did not meet internal quality specifications were inadvertently distributed.
FDA-determined cause: Storage
Action taken
React Health notified its sole consignee on 2/4/2026 via email. They followed with a MEDICAL DEVICE RECALL NOTIFICATION also sent via email on 3/5/2026. The notice explained the issue, potential risk, and requested the consignee contact React Health Customer Support at 863-226-6285 to discuss shipping arrangements, if necessary. For any questions, please contact React Health directly at 863-226-6285 , Monday through Friday between 8:00 a.m. - 5:00 p.m. Eastern Time (ET).
Details
- Recall number
- Z-1815-2026
- Initiated
- February 4, 2026
- Posted by FDA
- April 15, 2026
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of NY.
- Recalling firm
- 3B Medical, Inc., Dublin, OH