Device recall
Z-2740-2026: Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog…
FDA device recall · Class II · 3B Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2740-2026 |
|---|---|
| Recall event | 99247 |
| Product | 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… |
| Product code | BZD |
| Recalling firm | 3B Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K112271 |
| FEI number | 3009096682 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database