Approximately 318,280 AirLife Isothermal Heated Infant Respiratory Breathing Circuits are being recalled because of a change in materials used in the gas pathway. This change may affect the safety of the device and the quality of the moisture (gas condensates) that reaches the infant patient. These products were sold nationwide and internationally under various model numbers and sizes ranging from 3-foot to 8-foot lengths.
The modified materials in the breathing circuit's gas pathway could potentially release unsafe substances or impact the quality of air delivered to infants, who are a highly vulnerable population. This creates a risk of respiratory complications or other safety issues during assisted breathing treatments.
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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