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Incident · Recall

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.

Occurred 2026-04-02 · da Vinci (and Ion) at South Korea · Intuitive Surgical · South Korea · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)

Machine-readable surfaces

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.
What robot 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)?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
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.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-07-14

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-14

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

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

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