Vyaire Medical recalls AirLife Adult Manual Resuscitators with faulty oxygen tubing that may cause breathing problems. Affected units have manufacturing dates 2017 or earlier. Stop using immediately to prevent life-threatening hypoventilation.
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 potentially broken oxygen tubing that could cause breathing problems. If the tubing fails, it might not deliver oxygen properly, risking serious health issues or death.
The oxygen tubing can break or become disassembled due to faulty manufacturing. This may cause the device to stop working properly, leading to insufficient oxygen delivery and potentially life-threatening hypoventilation.
Healthcare professionals and emergency responders who use these resuscitators are most at risk. Anyone with the affected model number or manufacturing date should check if they own it.
Check for the model number REF 2K8004 on the device. Products manufactured in 2017 or earlier, or those without a manufacturing date, are affected.
The affected resuscitators may stop working properly and cause life-threatening breathing issues. Do not use until you contact Vyaire Medical.
The oxygen tubing may break due to faulty manufacturing, causing the device to fail and potentially lead to life-threatening hypoventilation.
Check for the model number REF 2K8004 and manufacturing dates of 2017 or earlier, or products without a manufacturing date.
Stop using it immediately and contact Vyaire Medical for 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-1065-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1065-2024 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.
