Integra LifeSciences is recalling 17,753 Cranial Access Kits because a defect in the sterile packaging (header bag) may compromise the sterility of the medical tools inside. These kits are used by medical professionals to access the brain's subarachnoid space or lateral ventricles. The recall includes various models such as the Integra Cranial Access Kit and Combo Kits distributed worldwide between 2023 and 2025. Consumers and healthcare providers should check for specific lot numbers and expiration dates to identify affected units.
A defect in the packaging seal means the tools may no longer be sterile; using a non-sterile device during a cranial procedure can lead to serious infections, such as meningitis or brain abscesses, which may be life-threatening.
Quarantine and contact manufacturer
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.