Recall of React Health PHOENIX 5L Oxygen Concentrator

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

3B Medical, Inc. is voluntarily recalling 2 units of the React Health PHOENIX 5L Oxygen Concentrator due to devices not meeting internal quality specifications, affecting US distribution.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

3B Medical, Inc. is recalling the React Health PHOENIX 5L Oxygen Concentrator because devices that did not meet internal quality specifications were inadvertently distributed.

Which Products Are Affected

The affected products are the React Health PHOENIX 5L Oxygen Concentrator with the following details: UDI codes 06934726614439-250623-MZJ5S713971 and 06934726614439-250623-MZJ5S714009, corresponding to serial numbers MZJ5S713971 and MZJ5S714009. A total of 2 units are involved in this recall, with distribution in the US nationwide, specifically in the state of New York. The recall number is Z-1815-2026.

What You Should Do

Consumers should check if their device matches the specified serial numbers and contact the recalling firm, 3B Medical, Inc., at their address: 5475 Rings Rd Ste 550, Dublin, OH 43017-7537, for further instructions regarding this voluntary recall.

Why This Matters

This recall involves medical devices that failed to meet quality standards, which could impact user safety in a limited scope given the small number of units affected.

Source

Attribution: FDA recall notice for event ID 98563. No specific link provided in the source data.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
3B Medical, Inc. is voluntarily recalling 2 units of the React Health PHOENIX 5L Oxygen Concentrator due to devices not meeting internal quality specifications, affecting US distribution.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.