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Regulation · Operational restriction

FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported)

FDA enforced a Class 2 recall of Intuitive Surgical 8mm SureForm 30 Gray Reloads following four serious injuries and one death associated with the device. The recall affects stapler reloads used with the da Vinci surgical system.

Jurisdiction: United States · Effective 2026-05-01

Machine-readable surfaces

Sources (1)

  1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/surgical-stapler-reload-recall-intuitive-surgical-removes-8mm-sureform-30-gray-reloads · 2026-05-01

Status history

  • In effect · 2026-05-01 · agent-recon

    Initial ingestion

Common questions

What does FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported) cover?
FDA enforced a Class 2 recall of Intuitive Surgical 8mm SureForm 30 Gray Reloads following four serious injuries and one death associated with the device. The recall affects stapler reloads used with the da Vinci surgical system.
Where does FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported) apply?
FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported) is recorded as a operational_restriction applying in United States on the DEPLOY registry.
When did FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported) take effect?
FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported) is recorded as effective May 1, 2026 on the DEPLOY registry.
Is FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported) still in effect?
FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported) is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported) apply to?
FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported) is recorded as applying to surgical on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported)?
8 robot models on the DEPLOY registry match the form-factor scope of FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported): ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported).

Canonical ID d87ffb80-5815-4cc2-8fc2-b1301f5aa6ee