FDA recall, , Moderate risk
3B Medical Rio II Nasal Pillows Interface
The Rio" II Nasal Pillows Interface has a packaging and labeling discrepancy involving product size identification and associated UDI.
Summary by Recall Canary from the FDA notice
What happened
3B Medical, Inc., of Dublin, Ohio, recalled the Rio" II Nasal Pillows Interface due to a packaging and labeling discrepancy involving product size identification and the associated Unique Device Identifier (UDI/GTIN). The recall began June 15, 2023, and was added to the FDA's Enforcement Report and classified on July 15, 2026. The product, intended for use with positive airway pressure therapy devices, had US Nationwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number and lot code are listed under that product.
Rio" II Nasal Pillows Interface
- Model number
- RII1001
- RII1002
- RII1003
- Lot code
- 220121
- 220191
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- 3B Medical, Inc.Dublin, Ohio
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99247
- Recall number
- Z-2740-2026
All recalls from 3B Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
