React Health PHOENIX 5L Oxygen Concentrator Class II Recall

Class 2 Device Recall React Health PHOENIX 5L Oxygen Concentrator

• FDA Home

• Medical Devices

- Databases

| |

| 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards |

| CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | |

| New Search | ) |

| | Class 2 Device Recall React Health PHOENIX 5L Oxygen Concentrator | |

5475 Rings Rd Ste 550
Dublin OH 43017-7537 |
| For Additional Information Contact | 863-226-6285 |
| Manufacturer Reason
for Recall | Devices which did not meet internal quality specifications were inadvertently distributed. |
| FDA Determined
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 in Commerce | 2 units |
| Distribution | US Nationwide distribution in the state of NY. |
| Total Product Life Cycle | TPLC Device Report |

| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

| 510(K) Database | 510(K)s with Product Code = CAW |