React Health PHOENIX 5L Oxygen Concentrator
FDA device recall Z-1815-2026 · posted 2026-04-15 · Open, Classified
Recall details
- Recalling firm
- 3B Medical, Inc.
- Reason for recall
- Devices which did not meet internal quality specifications were inadvertently distributed.
- 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).
- Root cause
- Storage
- Status
- Open, Classified
- Product code
- CAW
- Quantity affected
- 2 units
- Distribution
- US Nationwide distribution in the state of NY.
- Date initiated
- 2026-02-04
- Date posted
- 2026-04-15
- Location
- Dublin, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Oxygen Concentrator, Model JAY-5AW (K213210) | Longfian Scitech Co., Ltd. | 2022-12-08 |