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 specific oxygen tubing that can break, causing improper ventilation and potentially life-threatening hypoventilation. This recall affects medical devices used in emergency situations.
The oxygen tubing can break or become disassembled due to faulty manufacturing, which may cause the device to fail and not deliver proper oxygen. This can result in hypoventilation or hypoxia, potentially causing death if used in emergency medical scenarios.
Healthcare professionals and emergency responders using the recalled AirLife resuscitators are most at risk, as faulty tubing can lead to inadequate oxygen delivery during critical medical situations.
Check for the model number REF 2K8005 on the device. Affected units were manufactured in 2017 or earlier and may lack a manufacturing date.
Immediately stop using the AirLife Adult Manual Resuscitator with the recalled oxygen tubing as it can cause life-threatening hypoventilation.
The oxygen tubing can break or become disassembled due to faulty manufacturing, which may cause the device to fail and not deliver proper oxygen.
The affected model is REF 2K8005 with manufacturing dates of 2017 or earlier.
Check for the model number REF 2K8005 and look for manufacturing dates of 2017 or earlier; units 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-1061-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1061-2024 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.
