FDA-Device2026-04-22Class IIPROCESSING DEFECT
3B Medical React Health PHOENIX 5L Oxygen Concentrator recalled for quality defects
OTHERNationwide distribution
Check your React Health PHOENIX 5L concentrator
3B Medical distributed 2 units of the React Health PHOENIX 5L Oxygen Concentrator that did not meet the company's internal quality standards. The devices were distributed in New York. No injuries have been reported.
- Check if your device serial number is MZJ5S713971 or MZJ5S714009
- Contact 3B Medical or your supplier if you have one of these units
- Do not use the device if you have confirmed it matches one of the recalled serial numbers
Hazard
Devices which did not meet internal quality specifications were inadvertently distributed.
Sold states
US Nationwide distribution in the state of NY.
Affected count
2 units
Manufactured in
5475 Rings Rd Ste 550, N/A, Dublin, OH, United States
Products
React Health PHOENIX 5L Oxygen Concentrator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1815-2026Don't want to check this manually?
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