Agency classClass IIOur severity:High FDA (Devices)·Z-1815-2026·Announced 2026-04-22

React Health oxygen concentrators distributed without meeting quality specifications

React Health is recalling two PHOENIX 5L Oxygen Concentrators that did not meet internal quality specifications but were inadvertently distributed.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where devices failing internal quality specifications reached patients, a risk of harm with no injuries reported in the source.

Plain-English summary

React Health is recalling the PHOENIX 5L Oxygen Concentrator. The action covers two units, serial numbers MZJ5S713971 and MZJ5S714009.

Devices which did not meet internal quality specifications were inadvertently distributed. The FDA classified the action as Class II.

Distribution was within the United States, in New York. The concentrators are supplied for patient oxygen therapy.

Users and suppliers should identify affected units using the serial numbers above and follow the instructions issued by React Health. Patients should not stop prescribed oxygen therapy without medical advice.

The recalled product

Product: React Health PHOENIX 5L Oxygen Concentrator
Manufacturer: 3B Medical, Inc.
Category: Medical Device — Oxygen concentrator
Hazard: quality-escape
out-of-specification
oxygen-therapy
class-ii
Affected units: 2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · 3B Medical, Inc.

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