Da Vinci 5 ASSY recall (Intuitive Surgical, Inc.)
Medical deviceClass IIOngoing
Summary: Intuitive Surgical, Inc. is recalling Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.. Reason: An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
What is being recalled
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Why
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US distribution: LA, MA, NY, PA, TX, and VA. (states named: Louisiana, Massachusetts, New York, Pennsylvania, Texas, Virginia)
How to tell if yours is affected
UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1428-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 17, 2025 |
| Reported | February 25, 2026 |
| Company | Intuitive Surgical, Inc. |
| Company location | Sunnyvale, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12 |
More recalls from Intuitive Surgical, Inc. · all medical device recalls · recalls from November 2025