Intuitive Surgical, Inc.: System, Surgical, Computer Controlled Instrument
Recall Summary Intuitive Surgical is recalling da Vinci surgical system components that may have been distributed with a defective E-brake retainer pin. If the pin fails to function properly, the surgical instrument's brake may not engage during a structural failure, potentially causing uncontrolled movement that could injure patient tissue. The affected parts have been distributed worldwide, including throughout the United States and multiple countries.
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- Da Vinci ASSY, PSS, SP1098, Part Number: 380601
- Reason
- Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8470c9a2-e5b9-498b-8560-496cc68ec9c6