Z-1815-2026Class II

React Health PHOENIX 5L Oxygen Concentrator

Name: Z-1815-2026 React Health PHOENIX 5L Oxygen Concentrator
Creator: 3B Medical, Inc.
Published: 2026-02-04
License: https://open.fda.gov/license/

3B Medical Inc / initiated 2026-02-04 / Open, Classified

FDA source

3B Medical, Inc. began a recall of React Health PHOENIX 5L Oxygen Concentrator on 2026-02-04. FDA classified it as Class II and gives the reason as "Devices which did not meet internal quality specifications were inadvertently distributed". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1815-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-04
Posted: 2026-04-15
Recalling firm: 3B Medical Inc
Product: React Health PHOENIX 5L Oxygen Concentrator
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Devices which did not meet internal quality specifications were inadvertently distributed.
FDA root cause: Storage
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).
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the state of NY.
Product codes and lots: UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1815-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15

Product code CAW

K213210Class IIOxygen Concentrator, Model JAY-5AWLongfian Scitech Co., Ltd. / cleared 2022-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)