FDAFDA · Food and drugs·Recall number Z-2740-2026
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
Published July 22, 2026 · Recall initiated: June 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- 3B Medical, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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