Vyaire Medical recalls AirLife Adult Manual Resuscitators with faulty oxygen tubing that may cause hypoventilation or hypoxia, potentially leading to death. Affected units have manufacturing dates of 2017 or earlier.
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 faulty oxygen tubing that could cause improper ventilation, leading to hypoventilation or hypoxia. This risk may result in serious health consequences if the device fails during use.
The faulty oxygen tubing can break or become disassembled, causing the device to fail and not provide adequate ventilation. This may result in hypoventilation or hypoxia, which can be fatal if the device is used during emergency medical procedures.
Healthcare professionals and emergency responders using the recalled AirLife resuscitators are most at risk, as improper ventilation could lead to life-threatening conditions during critical medical situations.
Check for the model number REF 2K8017 on the device. Affected units were manufactured in 2017 or earlier and may lack a manufacturing date.
Immediately discontinue use of the recalled AirLife Adult Manual Resuscitator if it has a manufacturing date of 2017 or earlier.
The faulty oxygen tubing can break or become disassembled, causing the device to fail and not provide adequate ventilation, which may lead to hypoventilation or hypoxia.
The affected model number is REF 2K8017.
Check for the model number REF 2K8017 and look for a manufacturing date of 2017 or earlier. Products without a manufacturing date are also affected.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1064-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1064-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
