Summary
The FDA issued a Class II for React Health PHOENIX 5L Oxygen Concentrator by 3B Medical, Inc.. Reason: Devices which did not meet internal quality specifications were inadvertently distributed..
Details
Source
Device Recall
External ID
Z-1815-2026
Action Date
2026-04-22
Status
Ongoing
Category
device
Product Description
React Health PHOENIX 5L Oxygen Concentrator
Lot/Code Info: UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
Quantity Affected: 2 units
Reason for Recall
Devices which did not meet internal quality specifications were inadvertently distributed.
Distribution
US Nationwide distribution in the state of NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-04
Company
Dublin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
3B Medical, Inc. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (3B Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 3B Medical, Inc. have FDA actions?
3B Medical, Inc. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1815-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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