Recall Ledger

React Health PHOENIX 5L Oxygen Concentrator recall (3B Medical, Inc.)

Medical deviceClass IIOngoing

Summary: 3B Medical, Inc. is recalling React Health PHOENIX 5L Oxygen Concentrator. Reason: Devices which did not meet internal quality specifications were inadvertently distributed.

What is being recalled

React Health PHOENIX 5L Oxygen Concentrator

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the state of NY. (states named: New York)

How to tell if yours is affected

UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1815-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedFebruary 4, 2026
ReportedApril 22, 2026
Company3B Medical, Inc.
Company locationDublin, OH, United States
Initiated byVoluntary: Firm initiated
Quantity2 units

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Official FDA record