Integra LifeSciences Corp. (NeuroSciences) is recalling 6 units of the INSPIRA AIR Balloon Dilation System 10x40. This airway balloon dilation catheter was packaged with the incorrect product inside the carton, meaning the device in the box does not match the label on the outside. There have been no reported injuries related to this packaging error.
Using an incorrect medical device during a procedure can lead to surgical delays while a replacement is found or potential injury if the wrong device is used on a patient. This could result in ineffective treatment or unintended damage to the airway.
Quantity: 6 units affected.
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.