Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit… — Class I medical device recall Z-1698-2025
Ongoing recall by Vyaire Medical, reported 2025-05-21, distributed nationwide. Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection
| Recall number | Z-1698-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2025-04-10 |
| Classified | 2025-05-09 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, ES, GB, IN, IT, NL, PL, QA, RO, SA, SI |
| Quantity | 3,053 |
| UPC / GTIN / UDI-DI | 10190752145160, 10889483595909, 30889483595903, 50190752145168 |
| Serial numbers | 0004247924, 0004247925, 0004252940, 0004252941, 0004256292, 0004256293, 0004256294, 0004256295, 0004272325, 0004272868, 0004278978, 0004279156, 0004280036, 0004285304, 0004288036, 0004289514 |
| Model numbers | AH265 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1698-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.