FDA DeviceClass IINotable

FDA Recall: Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (S

Date: 2026-07-22
Brand: 3B Medical, Inc.
Category: Medical Device
FDA Class: Class II

Description

Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

Hazard

Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

Remedy

375

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