3B Medical, Inc. recalls Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Numbe…

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

This is a retroactively reported action. On June 22, 2023, the firm notified affected customers via letter titled "Urgent Medical Device Recall." Customers were informed of the incorrect labeling. Customers were asked to examine their inventory to determine if they had any of the affected products on-hand. Customers were to discontinue distribution of identified products and to destroy any affected products on hand. Firm offered to issue credit memo. If product was further distributed, customers were asked to notify patients/downstream accounts and have the product returned for disposal.

• FDA enforcement recordOfficial FDA database entry for Z-2740-2026
• FDA 510(k) clearance · K112271The device's official FDA premarket clearance record
• FDA device classification · BZDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5905The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find 3B Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.