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Incident · Recall

Intuitive Surgical recalls da Vinci staplers after death and injuries

Intuitive Surgical recalled its da Vinci surgical staplers after reports of death and injuries. The FDA received a petition requesting a voluntary recall of the da Vinci 5 system due to safety concerns with the stapling functionality.

Occurred 2026-04-15 · 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.
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Sources (2)

  1. https://www.mddionline.com/surgical/from-cyber-criminals-to-recalls-inside-intuitive-surgical-s-newest-snag
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Intuitive&postdatefrom=01/01/2026&postdateto=12/31/2026

Status history

  • Active · 2026-07-08 · agent:depth

Common questions

What happened in Intuitive Surgical recalls da Vinci staplers after death and injuries?
Intuitive Surgical recalled its da Vinci surgical staplers after reports of death and injuries. The FDA received a petition requesting a voluntary recall of the da Vinci 5 system due to safety concerns with the stapling functionality.
When did this incident occur?
The incident is recorded as occurring on April 15, 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 staplers after death and injuries?
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 staplers after death and injuries?
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 staplers after death and injuries?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (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
unclassified
Unclassified source
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 staplers after death and injuries.

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Canonical ID a2ea56b5-a224-4b06-bf36-e19b7398cf22