Vyaire Medical recalls AirLife Adult Manual Resuscitators with faulty oxygen reservoir tubing that may cause hypoventilation or hypoxia, risking 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 a specific oxygen reservoir tubing model due to a risk of hypoventilation. This could lead to inadequate breathing or oxygen levels, potentially causing death if the device fails during use.
The oxygen reservoir tubing may break or become disassembled due to faulty mold/tooling, leading to improper ventilation. This can cause hypoventilation or no ventilation, resulting in low oxygen levels and potentially death.
Healthcare professionals and emergency responders using the recalled AirLife resuscitators are most at risk. Patients receiving care with these devices could face life-threatening breathing issues.
Check for the model number REF 2K8005C2 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 tubing model to prevent hypoventilation risks.
The oxygen reservoir tubing may break or disassemble due to faulty mold/tooling, causing hypoventilation or no ventilation that could lead to death.
The AirLife Adult Manual Resuscitator with REF 2K8005C2 oxygen reservoir tubing, manufactured in 2017 or earlier.
Look for the model number REF 2K8005C2 and check if it was manufactured in 2017 or earlier, or lacks a manufacturing date.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1063-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1063-2024 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.
