Medical device recalls Moderate risk

3B Medical, Inc. recalls React Health PHOENIX 5L Oxygen Concentrator

Recall date
February 4, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1815-2026
FDA classification
Class II
Brand / firm
3B Medical, Inc.
Sold / distributed
US Nationwide distribution in the state of NY.

Why it was recalled

Devices which did not meet internal quality specifications were inadvertently distributed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

React Health PHOENIX 5L Oxygen Concentrator

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