FDA recall, , Moderate risk
React Health PHOENIX 5L Oxygen Concentrator
The React Health PHOENIX 5L Oxygen Concentrator was distributed without meeting internal quality specifications.
Summary by Recall Canary from the FDA notice
What happened
3B Medical, Inc., of Dublin, Ohio, is recalling the React Health PHOENIX 5L Oxygen Concentrator because devices which did not meet internal quality specifications were inadvertently distributed. The recall began February 4, 2026, and was added to the FDA's Enforcement Report on April 15, 2026.
The recalled devices were distributed in the state of New York. The recall involves 2 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
React Health Phoenix 5L Oxygen Concentrator
- UDI-DI
- 06934726614439
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of New York.
- Company
- 3B Medical, Inc.Dublin, Ohio
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98563
- Recall number
- Z-1815-2026
- Quantity recalled
- 2 units
All recalls from 3B Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
