Incident · Recall
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.
Occurred 2026-03-11 · da Vinci (and Ion)
Machine-readable surfaces
- Markdown mirror: /incidents/davinci-sureform-gray-reload-recall-death-2026.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/incidents/e5e34795-0e48-49e1-8427-019ec1b1a86b
- Data documentation: /data
Sources (1)
Common questions
- 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) is the recorded robot involved in this incident.
- 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.
Methodology: Verified · 1 source (no primary) · last reviewed 2026-06-04
Verification posture
Verified
Low confidence
Review state
Stable
Last reviewed 2026-06-04
Sources by quality tier
- 1
- secondary-trade-publication
- Trade publication
The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.
Methodology surface for da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries).Canonical ID e5e34795-0e48-49e1-8427-019ec1b1a86b