Reported Jul 22, 2026 · Ongoing · Updated Sep 16, 2026
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002…
3B Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: 3B Medical, Inc. · 5475 Rings Rd Ste 550 · Dublin, OH · 43017-7537
Is this the product you have?
- Brand NameRio"
- II Product NameRio" II Nasal
- Pillows Interface Model/Catalog Number
RII1001 (Small)RII1002 (Medium)
- RII1003 (Large) Software VersionN/A
- Product DescriptionNasal 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
- ComponentNo
- Lot codes and dates
- Lot CodeAffected
- Catalog Numbers
RII1001RII1002
- RII1003 Affected Lots RII1001220121 220121 220191
- RII1002220121 220121 220191
- RII1003220121 220121 220191
- Amount recalled
- 375
Where it was sold
- Nationwide
Why it was recalled
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
This product could cause temporary or reversible health problems — stop using it.
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