FDA Recall
Open, Classified
React Health PHOENIX 5L Oxygen Concentrator
Recall: Z-1815-2026
·
Initiated February 4, 2026
Recall
- Recall Number
- Z-1815-2026
- Event Number
- 98563
- Firm
- 3B Medical, Inc. 5475 Rings Rd Ste 550 Dublin OH 43017-7537
- FEI Number
- 3009096682
- Product Code
- CAW
- Status
- Open, Classified
- Root Cause
- Storage
- Initiated
- February 4, 2026
- Posted
- April 15, 2026
Description
React Health PHOENIX 5L Oxygen Concentrator
Reason
Devices which did not meet internal quality specifications were inadvertently distributed.
Action
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).
Distribution
US Nationwide distribution in the state of NY.
Quantity
2 units