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U.S. Department of Health and Human Services

Class 2 Device Recall React Health PHOENIX 5L Oxygen Concentrator

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 Class 2 Device Recall React Health PHOENIX 5L Oxygen Concentratorsee related information
Date Initiated by FirmFebruary 04, 2026
Date PostedApril 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1815-2026
Recall Event ID 98563
510(K)NumberK213210 
Product Classification Generator, oxygen, portable - Product Code CAW
ProductReact Health PHOENIX 5L Oxygen Concentrator
Code Information UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
FEI Number 3009096682
Recalling Firm/
Manufacturer		 3B Medical, Inc.
5475 Rings Rd Ste 550
Dublin OH 43017-7537
For Additional Information Contact
863-226-6285
Manufacturer Reason
for Recall		Devices which did not meet internal quality specifications were inadvertently distributed.
FDA Determined
Cause 2		Storage
ActionReact 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 Commerce2 units
DistributionUS Nationwide distribution in the state of NY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CAW
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