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RobotRisk / Intuitive Surgical / 2025-02-26
medical robotics · recall

Class II recall of da Vinci 5 foot pedal over spring failure

S3 · 02/26
2025 · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typerecall
Date02/26
2025
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
Scaleda Vinci 5 systems, foot pedal component
Confidencemedium
VerificationCited source on file; not independently re-verified
SourceMassDevice

What happened

FDA designated a recall of the Intuitive da Vinci 5 surgical robot system as Class II after the company warned customers of an increase in complaints about the foot tray pedal spring failing.

Intuitive Surgical record context

Entries by year and severity

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medical robotics: failure modes

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recall context

recall: by category

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recall: severity profile

Comparable recall events in medical robotics

SevDateCompanyEvent
S22026-06-09CMR SurgicalClass II recall of Versius surgeon console over disabled Secure Boot cybersecurity control
S42026-03-25OmnicellFDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S52026-03-11Intuitive SurgicalClass I recall of da Vinci SureForm stapler reloads after patient death
S32026-01-21Auris Health (J&J MedTech)FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S32025-09-12Noah MedicalFDA Class II recall: Brand Name: Galaxy System
S32025-05-23Quantum SurgicalFDA Class II recall: EPIONE Model 30-0001
S32025-04-23Virtual IncisionFDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S32024-10-28Noah MedicalFDA Class II recall: Galaxy System (GAL-001).

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