Device recall

Z-1698-2025: Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit…

FDA device recall · Class I · Vyaire Medical

Key facts

Recall number (Z-number) Z-1698-2025
Recall event 96664
Product Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for…
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

Browse all FDA device recalls (products)