Intuitive Surgical recalled 219 da Vinci surgical systems on November 7, 2025, due to a software error. This error allowed malfunctioning instrument arms to remain in clinical use, posing a high risk of failure. Healthcare providers and patients must stop using these systems immediately.
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
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 affects da Vinci X, Xi, and da Vinci 5 surgical systems with model numbers IS4000, IS4200, and IS5000. These systems were distributed in the U.S. and internationally, including countries like Germany, Japan, and the United Kingdom.
A software implementation error allowed Universal Surgical Manipulator arms failing a diagnostic test to remain in use. This situation presents a high risk of potential fatigue failure, which could lead to surgical complications.
There have been no reported injuries or deaths associated with this recall. However, the potential for malfunction poses serious risks during surgical procedures.
Patients and healthcare providers should stop using the affected systems immediately. They should contact Intuitive Surgical or their healthcare provider for further instructions and follow the recall notification provided.
For more information, call Intuitive Surgical at the provided contact number or visit their website. Additional instructions can be found at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1232-2026.
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