Vyaire Medical: Device Recall
Recall #Z-1697-2025 · 04/10/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-1697-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Vyaire Medical
- Status
- Ongoing
- Date Initiated
- 04/10/2025
- Location
- Mettawa, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1895
Reason for Recall
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Product Description
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 ventilator.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
Other Recalls by Vyaire Medical
- Class I: Dangerous 04/10/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.