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Open, Classified

React Health PHOENIX 5L Oxygen Concentrator

FDA Recall Z-1815-2026 · Posted 2026-04-15

Recalling Firm3B Medical, Inc.
Recall StatusOpen, Classified
Product CodeCAW
Date Initiated2026-02-04
Product Quantity2 units

Reason for Recall

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

Firm Action

React Health notified its sole consignee on 2/4/2026 via email. They followed with a MEDICAL DEVICE RECALL NOTIFICATION also sent via email on 3/5/2026. The notice explained the issue, potential risk, and requested the consignee contact React Health Customer Support at 863-226-6285 to discuss shipping arrangements, if necessary. For any questions, please contact React Health directly at 863-226-6285 , Monday through Friday between 8:00 a.m. - 5:00 p.m. Eastern Time (ET).

Root Cause

Storage

Distribution Pattern

US Nationwide distribution in the state of NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213210Oxygen Concentrator, Model JAY-5AWLongfian Scitech Co., Ltd. · 2022-12-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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