Vyaire Medical recalls AirLife Adult Manual Resuscitators with faulty components 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 faulty components causing hypoventilation or hypoxia, which could lead to death. This recall affects units manufactured in 2017 or earlier.
The device may have faulty components due to mold/tooling issues, leading to broken duckbill and ring parts. This can cause improper or no ventilation, resulting in hypoventilation or hypoxia, which may be fatal.
Medical professionals and emergency responders who use the AirLife Adult Manual Resuscitator for patient care are most at risk. Affected units were manufactured in 2017 or earlier and lack a manufacturing date.
Check for manufacturing dates of 2017 or earlier on the unit. Products without a manufacturing date are also affected. The product reference code is REF 2K8004C2.
Immediately stop using the AirLife Adult Manual Resuscitator if it was manufactured in 2017 or earlier or lacks a manufacturing date.
The device may have faulty components due to mold/tooling issues, leading to broken duckbill and ring parts that can cause improper or no ventilation, resulting in hypoventilation or hypoxia.
Using the affected units may cause hypoventilation or hypoxia, which could lead to death due to improper ventilation.
Check for manufacturing dates of 2017 or earlier or products without a manufacturing date. The product reference code is REF 2K8004C2.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1060-2024 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1060-2024 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.
