3B Medical, Inc. recalls React Health PHOENIX 5L Oxygen Concentrator

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

React Health PHOENIX 5L Oxygen Concentrator

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).

• FDA enforcement recordOfficial FDA database entry for Z-1815-2026
• FDA 510(k) clearance · K213210The device's official FDA premarket clearance record
• FDA device classification · CAWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find 3B Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.