Oxygen Concentrator Recall: Rio II Nasal Pillows Interface
Announced 2026-07-22 · FDA
Two units of the React Health PHOENIX 5L Oxygen Concentrator from 3B Medical, Inc. were distributed nationwide in the US, including New York, and are recalled because the devices did not meet internal quality specifications. Recall numbers include UDI 06934726614439-250623-MZJ5S713971 (Serial Number MZJ5S713971) and UDI 06934726614439-250623-MZJ5S714009 (Serial Number MZJ5S714009).
| Brand | 3B Medical, Inc. |
|---|---|
| Product | React Health PHOENIX 5L Oxygen Concentrator |
| Reason | Devices which did not meet internal quality specifications were inadvertently distributed. |
| Severity | moderate |
| Units affected | 375 |
| Distribution | US Nationwide distribution in the state of NY. |
| Agency | FDA |
| Recall / campaign no. | UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009 |
WHAT YOU SHOULD DO
- Check if your oxygen concentrator's serial number matches the ones listed.
- Do not use the device until you receive specific recall instructions.
- Contact 3B Medical customer service to verify status and arrange return, replacement, or remedy as directed.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.