FDA-Device2026-04-22Class IIPROCESSING DEFECT
3B Medical React Health PHOENIX 5L Oxygen Concentrator recalled for quality defects
What this means
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
The agency's original wording
Hazard
Devices which did not meet internal quality specifications were inadvertently distributed.
Intended for
Adults
Illnesses reported
None reported
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-1815-2026More 3B Medical recalls
- FDA-Device2026-07-223B Medical Rio II nasal pillows recalled for packaging labeling discrepancy
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