Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (S
- Recall date
- 2026-07-22
- Brand
- 3B Medical, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Product description
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Affected products
Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191