Vyaire Medical recalls AirLife Adult Manual Resuscitators with faulty oxygen reservoir bags 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 that may have broken duckbill and ring components, causing improper ventilation. This could lead to hypoventilation or hypoxia, which might be life-threatening.
The faulty mold/tooling produced components that may break or disassemble during use, leading to improper oxygen flow. This can cause hypoventilation (inadequate breathing) or no ventilation, resulting in hypoxia (low oxygen levels) and potentially death.
Healthcare professionals and emergency responders using the recalled AirLife resuscitators are most at risk, as improper ventilation could cause life-threatening conditions during medical emergencies.
Check for manufacturing dates of 2017 or earlier. Products without a manufacturing date are also affected. The product code REF 2K8004F is used on the affected units.
Immediately stop using the AirLife Adult Manual Resuscitator if it has a manufacturing date of 2017 or earlier or lacks a manufacturing date.
The recall is due to faulty mold/tooling that may cause the duckbill and ring components to break or disassemble, leading to improper ventilation and potential hypoventilation or hypoxia.
The recall covers AirLife Adult Manual Resuscitators with manufacturing dates of 2017 or earlier, or any units without a manufacturing date, identified by the product code REF 2K8004F.
The official recall does not provide a fix; the remedy is not stated in the record.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1059-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1059-2024 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.
