Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death
[RECALL]Mar 11, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Mar 11, 2026
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
In March 2026, Intuitive Surgical recalled the gray reload cartridges for its da Vinci 8 mm SureForm 30 curved-tip stapler after incomplete staple line formation on blood vessels caused dangerous bleeding. As of late February 2026, the company reported four serious injuries and one patient death. Intuitive notified surgeons on March 11 to stop using gray reloads and switch to alternatives; the FDA amplified the issue through its early-alert program.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-surgical-stapler-issue-intuitive-surgical
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-surgical-stapler-issue-intuitive-surgical
- Inspect Filing
https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death
https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death
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Details
Incident Context & FAQ
What happened in Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death?
In March 2026, Intuitive Surgical recalled the gray reload cartridges for its da Vinci 8 mm SureForm 30 curved-tip stapler after incomplete staple line formation on blood vessels caused dangerous bleeding. As of late February 2026, the company reported four serious injuries and one patient death. Intuitive notified surgeons on March 11 to stop using gray reloads and switch to alternatives; the FDA amplified the issue through its early-alert program.
When did this incident occur?
The incident is recorded as occurring on March 11, 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 recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death?
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 recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.