Vyaire Medical recalls AirLife Infant Heated Wire Circuit model AH165 due to risk of disconnection during use, which can cause severe health issues in neonates.
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.
Vyaire Medical is recalling AirLife Infant Heated Wire Circuits model AH165 because adapters may disconnect, potentially causing life-threatening issues for newborns. This recall is critical as even minor disconnections can lead to serious health complications in neonates.
The adapters in the AirLife Infant Heated Wire Circuit can disconnect during setup or while in use. This disconnection can interrupt ventilation, leading to hypoxia, hypercapnia, and organ failure in newborns.
Newborns using the AirLife Infant Heated Wire Circuit model AH165 are at risk. Parents and caregivers of neonates with this specific medical device should take immediate action.
Check for the model number AH165 on the device. The lot numbers include 0004240347, 0004240348, 0004252021, and other specific serial numbers listed in the recall notice.
Immediately stop using the AirLife Infant Heated Wire Circuit model AH165 if it is connected to a ventilator.
The model number is AH165.
The lot numbers include 0004240347, 0004240348, 0004252021, 0004253194, 0004253470, 0004255176, 0004260100, 0004262183, 0004262987, 0004263371, 0004292077, 0004300092, and 0004301668.
The recall notice does not mention any remedy or replacement options.
We’ve drafted a message you can send AirLife to request your refund or repair — edit it as you like.
Subject: Recall Z-1697-2025 — AirLife AirLife Hello, I own a AirLife that is covered by recall Z-1697-2025 from AirLife. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.