Z-2740-2026 Class II Ongoing
FDA device recall Z-2740-2026 was initiated by 3B Medical, Inc. on June 15, 2023 and is designated Class II. Reason for recall: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). The recall status is ongoing. Affected quantity: 375.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2026
- Initiation Date
- June 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 375
Product Description
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal 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. Component: No
Reason for Recall
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191