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

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Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191

Why: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Distributed: US Nationwide distribution.
Company: 3B Medical, Inc.
Announced: 22 July 2026
Recall began: 15 June 2023

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