FDA recall, , Moderate risk
Intuitive Surgical Da Vinci 5 Console
The Da Vinci 5 surgical system can have an error event causing loss of user interface content on a monitor.
Summary by Recall Canary from the FDA notice
What happened
Intuitive Surgical, Inc., of Sunnyvale, California, recalled the Da Vinci 5 ASSY, DV5 CONSOLE, IS5000, used for minimally invasive surgery, because an error event following the release of a software version can result in loss of user interface content on an external monitor or tower monitor. The recall began November 17, 2025, and was added to the FDA's Enforcement Report on February 18, 2026, affecting Louisiana, Massachusetts, New York, Pennsylvania, Texas and Virginia.
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?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Da Vinci 5 Assy, DV5 Console, IS5000
- Model number
- 380730
- UDI-DI
- 00886874119747
- 0886874119747
Recall details
- Company began the recall
- Sold in
- 6 states
- 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
- 98200
- Recall number
- Z-1428-2026
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
