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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) 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.
Track da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)

Machine-readable surfaces

Outcomes (2)

  • regulatory actionverified
  • fatalityverified

Revision history (5)

  • 2026-06-05 · loss_cost_class · undisclosed
  • 2026-06-05 · bodily_injury_severity · reported_press
  • 2026-06-05 · fatality_count
  • 2026-06-05 · outcome_class
  • 2026-06-05 · outcome_class

Outcome rows carry verification_posture independently. Revision events carry basis (verified_court_filing, verified_insurance, reported_press, estimate, undisclosed). The framework records outcomes only when verifiable; absence is honest absence, not a claim of no-impact.

Sources (1)

  1. MedTech Dive · https://www.medtechdive.com/news/intuitive-surgical-recalls-stapler-reloads-over-issue-linked-to-patient-dea/815158/

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) 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.
Methodology: Verified · 1 source (no primary) · last reviewed 2026-07-21

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-07-21

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).

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Canonical ID e5e34795-0e48-49e1-8427-019ec1b1a86b