Device recall
Z-1697-2025: Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit…
FDA device recall · Class I · Vyaire Medical
Key facts
| Recall number (Z-number) | Z-1697-2025 |
|---|---|
| Recall event | 96664 |
| Product | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a… |
| Product code | BZE |
| Recalling firm | Vyaire Medical |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K151303 |
| FEI number | 3013421741 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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