FDA Class 2 Recall: Intuitive Surgical 8mm SureForm 30 Gray Reloads (Serious Injury and Death Reported)
[in effect]United States · operational restriction · operational restriction
Jurisdiction
United States
Classification
operational restriction
Status
in effect
Effective Date
May 1, 2026
Primary Sources
1 audited
Statutory Scope & Summary
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.
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat 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.
Primary Sources & Legal Instruments
1 document- https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/surgical-stapler-reload-recall-intuitive-surgical-removes-8mm-sureform-30-gray-reloadsOfficial Source
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/surgical-stapler-reload-recall-intuitive-surgical-removes-8mm-sureform-30-gray-reloads