Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH16...

FDA Device Recall #Z-1697-2025 — Class I — April 10, 2025

Recall Summary

Recall Number Z-1697-2025
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 1895

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.

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): 0004240347 0004240348 0004252021 0004253194 0004253470 0004255176 0004260100 0004262183 0004262987 0004263371 0004292077 0004300092 0004301668 UDI-DI AirLife Label Each: 10889483595862 Case: 30889483595866 Vyaire Label Each: 10190752145139 Case: 50190752145137

Other Recalls from Vyaire Medical

Recall # Classification Product Date
Z-1698-2025 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.