← FDA ENFORCEMENT
Z-1815-2026Class II

3B Medical, Inc.

Recalling firm
3B Medical, Inc.
Product type
Device
Status
Ongoing
Report date
2026-04-22
Distribution
US Nationwide distribution in the state of NY.
Firm state
OH
Product quantity
2 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

React Health PHOENIX 5L Oxygen Concentrator

Code / lot info

UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.