Is 3B Medical, Inc. recalled?

Yes — a recall has been published. Reason: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

TemporaryFDAOngoing

Can cause harm that is usually temporary.

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

Check the device or its packaging for

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 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 15 June 2023

Source: FDA record Z-2740-2026 · retrieved 15 July 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.