Recall archive / FDA device enforcement
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery. — FDA record Z-1428-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 12
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1428-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution: LA, MA, NY, PA, TX, and VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 25, 2026
- Recall initiation date
- Nov 17, 2025
- Center classification date
- Feb 18, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.