3B Medical, Inc. recalls Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface
- Recalling company
- 3B Medical, Inc.
- 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
- Reason
- Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 15, 2023
- Reported
- Jul 22, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 375
- Lot / codes
- Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191
- Company location
- Dublin, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2740-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2740-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.