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3B Medical, Inc. recalls Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medi
Recalled July 22, 2026 · FDA recall Z-2740-2026 · 3B Medical
Hazard
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). · FDA Class II
Units
375
Sold at
US Nationwide distribution.
Description
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Product
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 from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
Manufacturer(s)
3B Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →