Recall Z-1815-2026— 3B Medical, Inc.

Name: FDA recall Z-1815-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-04

Class II · Ongoing

Class II FDA medical device recall by 3B Medical, Inc., initiated 2026-02-04. It names one FDA 510(k) clearance: K213210. Product: React Health PHOENIX 5L Oxygen Concentrator. Reason: Devices which did not meet internal quality specifications were inadvertently distributed..

Recalling firm: 3B Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-02-04
Firm location: Dublin, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K213210 — Oxygen Concentrator, Model JAY-5AWLongfian Scitech Co., Ltd.·cleared 2022-12-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

React Health PHOENIX 5L Oxygen Concentrator

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.