Recall Z-1815-2026 ยท CAW Generator, Oxygen, Portable
3B Medical, Inc.
React Health PHOENIX 5L Oxygen Concentrator
| Date | Apr 15, 2026 (initiated Feb 4, 2026) |
| Status | Open, Classified |
| Reason | Devices which did not meet internal quality specifications were inadvertently distributed. |
| Root cause | Storage |
| 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). |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213210 | Oxygen Concentrator, Model JAY-5AW Longfian Scitech Co., Ltd., Dec 8, 2022 |