Vyaire Medical recalls AirLife Adult Manual Resuscitators with REF 2K8000 due to risk of hypoventilation from broken duckbill and ring. Affected units manufactured 2017 or earlier without a date.
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Vyaire Medical is recalling AirLife Adult Manual Resuscitators with REF 2K8000 because faulty components can cause improper ventilation, leading to hypoventilation or hypoxia. This could result in serious health risks or death if the device fails during use.
The device contains a faulty duckbill and ring that can break or become disassembled, causing improper ventilation. This may lead to hypoventilation or hypoxia, which can be life-threatening if the device fails during critical medical use.
Medical professionals and emergency responders who use the AirLife Adult Manual Resuscitator with REF 2K8000. Those with the device manufactured in 2017 or earlier without a manufacturing date are most at risk.
Check for the product code REF 2K8000 on the AirLife Adult Manual Resuscitator. Affected units were manufactured in 2017 or earlier and may not have a manufacturing date.
Immediately stop using the AirLife Adult Manual Resuscitator with REF 2K8000 if it was manufactured in 2017 or earlier without a manufacturing date.
The device has a faulty duckbill and ring that can break or become disassembled, causing improper ventilation and potentially leading to hypoventilation or hypoxia, which can be life-threatening.
Check for the product code REF 2K8000. Affected units were manufactured in 2017 or earlier and may not have a manufacturing date.
Immediately stop using it and contact Vyaire Medical for further instructions.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1057-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1057-2024 from Vyaire Medical. 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.
