Brand Name: Rio" II Product Name: Rio" II Nasal Pillows recall: Labeling Error
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software…
Why was Brand Name: Rio" II Product Name: Rio" II Nasal Pillows recalled?
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191
- Product
- Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software…
- Recalling firm
- 3B Medical, Inc.
- Quantity
- 375
- Distribution
- US Nationwide distribution.
- Recall date
- July 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)