Reported May 21, 2025 · Ongoing
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A…
Vyaire Medical
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vyaire Medical · 26125 N Riverwoods Blvd · Mettawa, IL · 60045-3420
Is this the product you have?
- Brand NameAirLife
- Product NameAirLife Infant Heated
- Wire Circuit Model/Catalog NumberAH165
- Software VersionN/A
- Product DescriptionAirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4
- L/min) ComponentNo. a conduit for respiratory gas between the patient and a ventilator
- Lot codes and dates
- Lot CodeLot/Serial
- Number(s)
0004240347000424034800042520210004253194000425347000042551760004260100000426218300042629870004263371000429207700043000920004301668
- UDI-DI AirLife Label Each10889483595862
- Case30889483595866
- Vyaire Label Each10190752145139
- Case50190752145137
- Amount recalled
- 1895
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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