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 oxygen reservoir tubing that may break, causing improper ventilation and potentially life-threatening hypoventilation. This recall affects units made in 2017 or earlier, which could lead to serious injury or death if not fixed.
The oxygen reservoir tubing may break due to faulty mold/tooling, causing the device to fail. This can result in improper or no ventilation, leading to hypoventilation or hypoxia, which may cause death.
Healthcare professionals and emergency responders using the AirLife resuscitators are most at risk. Patients receiving care with these devices could face hypoventilation or hypoxia if the faulty tubing fails.
Check for manufacturing dates of 2017 or earlier. Products without a manufacturing date are also affected. The product includes a specific reference number (REF 2K8005F).
Immediately stop using the AirLife Adult Manual Resuscitator if it has a manufacturing date of 2017 or earlier.
The oxygen reservoir tubing may break due to faulty mold/tooling, causing improper ventilation and potentially life-threatening hypoventilation.
Stop using it immediately and contact Vyaire Medical for instructions.
Products manufactured after 2017 are not affected by this recall.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1062-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1062-2024 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.
