FDA Medical devices recall ·
AirLife Product Name: AirLife Infant Heated Wire Circuit Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1698-2025
- Date
- (initiated April 10, 2025)
- Company / brand
- Vyaire Medical
26125 N Riverwoods Blvd, Mettawa, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 3053
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1698-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.