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

Medical DevicesSource: FDA (device) · Date: 2026-04-22

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
3B Medical, Inc.
Product
React Health PHOENIX 5L Oxygen Concentrator
Reason / hazard
Devices which did not meet internal quality specifications were inadvertently distributed.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of NY.
Recall initiated
2026-02-04
Code info
UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
Product quantity
2 units
Voluntary mandated
Voluntary: Firm initiated
City
Dublin
State
OH
Country
United States
Event id
98563
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