Home/Recalls/FDA-Z-1815-2026
FDA DevicesClass II

React Health PHOENIX 5L Oxygen Concentrator

Published: April 22, 2026Recall ID: Z-1815-2026Category: devicesCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

React Health PHOENIX 5L Oxygen Concentrator

Additional Source Details

FieldValue
CityDublin
StateOH
Event id98563
Address 15475 Rings Rd Ste 550
Address 2N/A
Code infoUDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
Postal code43017-7537
Report date20260422
Product typeDevices
Product quantity2 units
Reason for recallDevices which did not meet internal quality specifications were inadvertently distributed.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260204
Initial firm notificationE-Mail
Center classification date20260415

Overview

  • Recalling Firm3B Medical, Inc.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide distribution in the state of NY.
Official Agency Alert