Integra LifeSciences Corp. has recalled 1,822 Integra Cranial Access Kits (without Prep solutions) Bit and Guard, which are used during ventriculostomy medical procedures. The recall was initiated because the sterile packaging (specifically the header bag) may have holes or tears, which can compromise the sterility of the instruments inside. This defect affects several lots with expiration dates in July and September 2025. Consumers should contact their healthcare provider or the manufacturer to discuss any concerns regarding these devices.
Holes or tears in the device packaging can allow contaminants to enter, compromising the sterility of the surgical tools. Using non-sterile instruments during a cranial procedure increases the risk of serious infection or other complications for the patient.
Contact healthcare provider or 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.