FDA 483 - Intuitive Surgical, Inc. - November 05, 2025

Intuitive Surgical, Inc. in Sunnyvale, CA, was inspected from 10/14/2025 to 11/5/2025, revealing significant deficiencies in its quality system. The inspection found inadequate procedures for corrective and preventive actions, design verification, risk analysis, and purchasing controls, leading to multiple product recalls and unreported field actions. Additionally, the firm failed to submit Medical Device Reports within the required 30-day timeframe, indicating a systemic failure to ensure product safety and regulatory compliance.