FDA-Device2026-07-22Class IIMISBRANDING
3B Medical Rio II nasal pillows recalled for packaging labeling discrepancy
What this means
3B Medical is recalling Rio II nasal pillows interfaces due to a packaging and labeling discrepancy affecting product size identification and device identifiers. The affected units have incorrect or mismatched labeling on certain lots, which could lead to patients receiving the wrong size for their CPAP or PAP therapy device.
- Check your Rio II nasal pillows packaging for lot code 220121 or 220191 (small, medium, or large models RII1001, RII1002, or RII1003).
- Contact 3B Medical customer service for verification of your product's correct size and identifier.
- Do not discard the device; follow manufacturer instructions for a replacement or return.
The agency's original wording
Hazard
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
375
Manufactured in
5475 Rings Rd Ste 550, Dublin, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2740-2026Want us to check the next one for you?
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