_Incident · Recall_

# Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)

Canonical ID: `8c7919af-a019-4ce8-9af5-954e718b9d42`

- **Occurred:** 2026-04-02
- **Kind:** `recall`
- **Status (derived):** active
- **Company:** [Intuitive Surgical](/companies/intuitive-surgical.md) (id: `e5127536-0ff2-4f0e-8488-64994cb2ffc7`)

On April 2, 2026, Intuitive Surgical initiated a Class 2 recall (FDA Z-2046-2026) of da Vinci X and Xi Surgical System Universal Surgical Manipulators (USMs) because screws within the arm sub-assembly may be susceptible to breaking. If all six screws break, the cannula mount can separate from the USM, potentially causing imprecise or unintended instrument tip motion during surgery. Intuitive sent Urgent Medical Device Correction letters to customers.

## Sources (1)

1. **FDA Medical Device Recall Database** · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=219087 · 2026-05-01

## Status history

- **active** · 2026-07-14 · agent:recon

## Common questions

### What happened in Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)?

On April 2, 2026, Intuitive Surgical initiated a Class 2 recall (FDA Z-2046-2026) of da Vinci X and Xi Surgical System Universal Surgical Manipulators (USMs) because screws within the arm sub-assembly may be susceptible to breaking. If all six screws break, the cannula mount can separate from the USM, potentially causing imprecise or unintended instrument tip motion during surgery. Intuitive sent Urgent Medical Device Correction letters to customers.

### When did this incident occur?

The incident is recorded as occurring on April 2, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### Who was involved in Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)?

The incident is recorded as involving Intuitive Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.

### Has anyone responded to Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)?

No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.

### What is the current status of Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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