Integra LifeSciences Corp. (NeuroSciences) has recalled 4,882 units of the MicroMyst Applicator (Model 205000DS). This applicator is used with the Integra Flow Source to deliver two liquids simultaneously during medical procedures. The recall was initiated because the products lack sterility assurance, meaning they may not be completely free of bacteria or other pathogens. No injuries or incidents have been reported to date.
Using a non-sterile medical device during surgery can introduce harmful pathogens directly into a patient's body. This poses a critical risk of serious infection, which could lead to severe health complications or life-threatening conditions.
All lots are 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 ยท 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.