Intuitive Surgical, Inc. is recalling 41,526 units of the da Vinci SP Access Port Kit (Large Incision) due to a defect in the packaging. The internal tray containing the access port system may develop cracks, which can compromise the product's sterile barrier. This recall involves the 2.7-4cm and 2.7-7cm models manufactured in the United States and distributed worldwide.
A cracked tray may allow bacteria or other contaminants to enter the packaging, resulting in a sterility breach. If a non-sterile device is used during a surgical procedure, it poses a significant risk of infection or other complications for the patient.
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
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