Vyaire Medical recalls AirLife Adult Manual Resuscitator oxygen tubing from 2017 and earlier due to risk of hypoventilation. Affected units may cause improper ventilation or no ventilation, potentially leading to death.
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 Resuscitator oxygen reservoir tubing from 2017 and earlier because faulty manufacturing can cause the tubing to break, leading to improper or no ventilation. This risk could result in hypoventilation or hypoxia, which may be life-threatening.
The tubing can break due to faulty mold/tooling, causing the duckbill and ring to disassemble. This may lead to improper or no ventilation, resulting in hypoventilation or hypoxia, which can be fatal.
Healthcare professionals using the AirLife resuscitator with the affected tubing, particularly those in emergency medical settings. Patients receiving care with this specific tubing are at risk of hypoventilation or hypoxia.
Check for the product code REF 2K8001 on the tubing. Affected units were manufactured in 2017 or earlier and lack a manufacturing date.
Immediately stop using the AirLife Adult Manual Resuscitator with the affected tubing as it may cause hypoventilation or hypoxia.
The tubing may break due to faulty mold/tooling, causing the duckbill and ring to disassemble, which can lead to improper or no ventilation.
Check for the product code REF 2K8001 on the tubing. Affected units were manufactured in 2017 or earlier and lack a manufacturing date.
Immediately stop using it and contact Vyaire Medical for instructions on disposal or replacement.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1058-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1058-2024 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.
