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 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.
The Access Port System tray may develop cracks that could lead to a sterility breach. This defect poses a high risk of infection during surgical procedures.
No specific incidents or injuries have been reported to date, but the potential for serious health risks exists due to the sterility issue.
Patients and healthcare providers should stop using the affected devices immediately. Contact Intuitive Surgical, Inc. or consult your healthcare provider for further instructions and return procedures.
For more information, contact Intuitive Surgical at 1-800-XXXX-XXXX or visit their website at www.intuitive.com.
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