# FDA recall Z-1815-2026

> **3B Medical, Inc.** · Class II · device recall initiated 2026-02-04.

## Product

React Health PHOENIX 5L Oxygen Concentrator

## Reason for recall

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

## Distribution

US Nationwide distribution in the state of NY.

## Key facts

- **Recall number:** Z-1815-2026
- **Recalling firm:** 3B Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-04
- **Report date:** 2026-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1815-2026

## Citation

> AI Analytics. FDA recall Z-1815-2026. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1815-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*