Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH26...
FDA Device Recall #Z-1698-2025 — Class I — April 10, 2025
Recall Summary
| Recall Number | Z-1698-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | April 10, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vyaire Medical |
| Location | Mettawa, IL |
| Product Type | Devices |
| Quantity | 3053 |
Product Description
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 respiratory gas between the patient and a ventilator.
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
Lot / Code Information
Lot Code: Lot/Serial Number(s): 0004247924 0004247925 0004252940 0004252941 0004256292 0004256293 0004256294 0004256295 0004272325 0004272868 0004278978 0004279156 0004280036 0004285304 0004288036 0004289514 UDI-DI: AirLife Label Each: 10889483595909 Case: 30889483595903 Vyaire Label: Each: 10190752145160 Case: 50190752145168
Other Recalls from Vyaire Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1697-2025 | Class I | Brand Name: AirLife Product Name: AirLife Infa... | Apr 10, 2025 |
| Z-1065-2024 | Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) O... | Jan 10, 2024 |
| Z-1061-2024 | Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) O... | Jan 10, 2024 |
| Z-1062-2024 | Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) O... | Jan 10, 2024 |
| Z-1064-2024 | Class I | AirLife Adult Manual Resuscitator, Variable Vol... | Jan 10, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.