FDA recall, , Moderate risk
Da Vinci X, Xi, and 5 Surgical Systems
The da Vinci surgical systems have a software error that can allow failing instrument arms to remain in use.
Summary by Recall Canary from the FDA notice
What happened
Intuitive Surgical, Inc., of Sunnyvale, California, recalled its da Vinci X, Xi Surgical System, and da Vinci 5 Surgical System because a software implementation error allowed instrument arms failing an important diagnostic test to remain in clinical use.
The test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned, a precursor to potential ball screw fatigue failure. The recall began November 7, 2025, and was added to the FDA's Enforcement Report on February 2, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number is listed.
da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System
- Model number
- IS4000
- IS4200
- IS5000
Recall details
- Company began the recall
- Sold in
U.S.: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. O.U.S.: Austria, Brazil, China, France, Germany, Greece, India, Italy, Japan, Lebanon, Netherlands, South Korea, Spain, Switzerland, Taiwan and United Kingdom
- Company
- Intuitive Surgical, Inc.Sunnyvale, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98050
- Recall number
- Z-1232-2026
All recalls from Intuitive Surgical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary