da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)
[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
Intuitive recalled 8mm SureForm 30 Gray reloads (2mm staples for extra-thin tissue) after incomplete staple lines on blood vessels despite a 'completed' fire indication, linked to one patient death and four serious injuries (bleeding). Customer letter / quarantine Mar 11 2026; FDA classified Class I (reported May 2026).
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.medtechdive.com/news/intuitive-surgical-recalls-stapler-reloads-over-issue-linked-to-patient-dea/815158/
https://www.medtechdive.com/news/intuitive-surgical-recalls-stapler-reloads-over-issue-linked-to-patient-dea/815158/
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Details
Incident Context & FAQ
What happened in da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)?
Intuitive recalled 8mm SureForm 30 Gray reloads (2mm staples for extra-thin tissue) after incomplete staple lines on blood vessels despite a 'completed' fire indication, linked to one patient death and four serious injuries (bleeding). Customer letter / quarantine Mar 11 2026; FDA classified Class I (reported May 2026). Blue/white reloads unaffected. Root cause stated 'still under investigation.' Cap-flag: exact recall Z-number + unit count not captured from primary FDA pages. Distinct from the 2022 SureForm fragment recall.
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 da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious 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 da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.