Recall Z-2740-2026 ยท BZD Ventilator, Non-Continuous (Respirator)
3B Medical, Inc.
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
| Date | Jul 15, 2026 (initiated Jun 15, 2023) |
| Status | Open, Classified |
| Reason | Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 375 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112271 | 3B WILLOW 3B Products, LLC, Feb 16, 2012 |