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medical robotics · recall

Class II recall of da Vinci reusable instruments (forceps, scissors, drivers, graspers) over cable fraying

S3 · · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typerecall
Date
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
Scalemultiple instrument models, US and international distribution
Confidencemedium
VerificationCited source on file; not independently re-verified
SourceMedTech Dive

What happened

Intuitive Surgical initiated FDA Class II recalls of multiple reusable da Vinci instrument types after an increase in complaints about frayed or broken internal cables causing instrument malfunction during procedures.

Intuitive Surgical record context

Entries by year and severity

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By incident type

By severity

Intuitive Surgical vs medical robotics alternatives

medical robotics context

medical robotics: entries by year

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medical robotics: failure modes

medical robotics: most entries

recall context

recall: by category

recall: by year

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
S32025-02-26Intuitive SurgicalClass II recall of da Vinci 5 foot pedal over spring failure

Other Intuitive Surgical entries

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