CLASS II ONGOING Device recall · Reported 22 Apr 2026 · FDA Enforcement Report
React Health Phoenix Oxygen Concentrator recalled by 3B Medical
3B Medical is recalling React Health Phoenix Oxygen Concentrator, distributed nationwide in the US. The recall was initiated on 4 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1815-2026
- FDA event ID
- 98563
- Recalling firm
- 3B Medical, Dublin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Feb 2026
- FDA classified
- 15 Apr 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 4 Feb 2026 | Recall initiated by company | |
| 15 Apr 2026 | Classified by FDA | +70 days |
| 22 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices which did not meet internal quality specifications were inadvertently distributed.
Product as listed by the FDA
React Health PHOENIX 5L Oxygen Concentrator
Where it was distributed
US Nationwide distribution in the state of NY.
Questions about this recall
Is React Health Phoenix Oxygen Concentrator recalled?
Yes. 3B Medical recalled React Health Phoenix Oxygen Concentrator on 4 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1815-2026.
Why was it recalled?
Devices which did not meet internal quality specifications were inadvertently distributed.
Which lots are affected?
UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
Where was it sold?
US Nationwide distribution in the state of NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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