The Recall Desk
HighFDA (Devices)·Z-1428-2026·Announced 2026-02-25

[pending] Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive

Pending LLM rewrite. Source: FDA_DEVICE Z-1428-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Manufacturer
Intuitive Surgical, Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1

Distribution

Distributed in 6 states:

  • LA
  • MA
  • NY
  • PA
  • TX
  • VA