Intuitive Surgical recalls da Vinci staplers after death and injuries
[RECALL]Apr 15, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Apr 15, 2026
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.mddionline.com/surgical/from-cyber-criminals-to-recalls-inside-intuitive-surgical-s-newest-snag
https://www.mddionline.com/surgical/from-cyber-criminals-to-recalls-inside-intuitive-surgical-s-newest-snag
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Intuitive&postdatefrom=01/01/2026&postdateto=12/31/2026
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Intuitive&postdatefrom=01/01/2026&postdateto=12/31/2026
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Details
Incident Context & FAQ
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.