Vyaire Medical is recalling approximately 6.7 million AirLife Adult Manual Resuscitators because a faulty manufacturing mold used prior to 2017 produced components that can break or come apart. If the device fails during use, it may deliver little to no oxygen to the patient, which can lead to serious injury or death. These products were distributed worldwide and include various models of adult manual resuscitators, some with masks, oxygen tubing, or CO2 detectors. Consumers should identify affected units by checking for manufacturing dates of 2017 and earlier or for units that lack a manufacturing date entirely.
A internal component called a duckbill valve or ring may break or disassemble due to being out of specification, causing the resuscitator to fail to provide adequate ventilation. This failure can result in hypoventilation (dangerously shallow breathing) or hypoxia (lack of oxygen to the brain and body), which can be fatal.
manufacturer or healthcare provider consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.