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3B Medical, Inc. recalls

RecallSweep is tracking 2 recall notices naming 3B Medical, Inc. in the last 180 days, issued by FDA. The most recent is dated July 22, 2026 and the oldest in this window April 22, 2026. They cover Medical Devices.

This page lists what the issuing agencies published. It is not a statement about 3B Medical, Inc. beyond those notices — open each official notice for the authoritative detail.

Recall notices naming 3B Medical, Inc.

2 recalls.

FDA Class II Medical Devices

3B Medical, Inc.: Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) So…

Affected quantity: 375

Hazard
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

Details
Distribution: US Nationwide distribution.. Recall #Z-2740-2026, initiated 20230615. Voluntary: Firm initiated.

Products affected
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow f…

Recall status
Ongoing

FDA Class II Medical Devices

3B Medical, Inc.: React Health PHOENIX 5L Oxygen Concentrator

Affected quantity: 2 units

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

Details
Distribution: US Nationwide distribution in the state of NY.. Recall #Z-1815-2026, initiated 20260204. Voluntary: Firm initiated.

Products affected
React Health PHOENIX 5L Oxygen Concentrator

Recall status
Ongoing

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