Intuitive Surgical recalled 41,526 da Vinci SP Access Port Kits on December 15, 2025, due to potential cracks in the tray that could breach sterility. The recall affects models 430073 and 430075, distributed worldwide including across the US and various countries. Patients and healthcare providers must stop using these devices immediately and follow manufacturer instructions for return.
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Intuitive Surgical, Inc. or your healthcare provider for instructions. Notification method: Letter
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The da Vinci SP Access Port Kit is used in robotic-assisted surgeries to enhance the surgical approach through minimally invasive techniques. Surgeons and healthcare providers buy these kits to perform complex surgeries with precision and reduced recovery time for patients.
Cracks in the Access Port System tray can compromise the sterility of surgical instruments, increasing the risk of postoperative infections. This defect can occur during normal handling and use of the device.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must address this recall urgently to prevent potential health risks associated with surgical procedures.
Reference numbers and lot numbers can typically be found on the product packaging or the device itself.
Expect refund processing to take approximately 4-6 weeks after returning the device.
Keep records of your purchase, any correspondence with the manufacturer, and documentation of the recall for future reference.
The recall involves da Vinci SP Access Port Kits with reference numbers 430073 (2.7-4cm) and 430075 (2.7-7cm). These products were distributed worldwide, including the US and countries across Europe and Asia, and were sold at multiple retailers.
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