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Medical robotics · S3 and above incidents

42 documented incidents where industry is Medical robotics and severity is S3 and above, across 21 companies, 2013-2026. Every row cites its source; severity runs S1 (near miss) to S5 (fatal or catastrophic). Entity pages: Medical robotics · S3 and above.

42Unique incidents
21Companies involved
S5Highest severity
88%Verified
67%From regulators
2013-2026Years covered

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Incident list

SevDateCompanyTypeLocationIncidentSource
S425 Mar 2026Omnicell recall —FDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station. · Rolls of label stock used with the Omnicell i.v.Station. openFDA enforcement
S418 Mar 2026Intuitive Surgical regulatory USAFDA issues emergency alert on da Vinci-compatible surgical stapler reloads after 1 death, 4 injuries HealthExec
S511 Mar 2026Intuitive Surgical recall —Class I recall of da Vinci SureForm stapler reloads after patient death · 1 death, 4 serious injuries; recall of affected lot to customers who ordered on/before Feb 20, 2026 FDA
S321 Jan 2026Auris Health (J&J MedTech) recall —FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0 · MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005- openFDA enforcement
S525 Oct 2025Grifols (Kiro) fatality Winnipeg, Manitoba, CanadaPlasma-collection machine issued alerts before Winnipeg donor's fatal cardiac arrest Winnipeg Free Press
S312 Sep 2025Noah Medical recall —FDA Class II recall: Brand Name: Galaxy System · Brand Name: Galaxy System openFDA enforcement
S323 May 2025Quantum Surgical recall —FDA Class II recall: EPIONE Model 30-0001 · EPIONE Model 30-0001 openFDA enforcement
S323 Apr 2025Virtual Incision recall —FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur · MIRA SURGICAL SYSTEM, Table mounted miniaturized electromech openFDA enforcement
S326 Feb 2025Intuitive Surgical recall —Class II recall of da Vinci 5 foot pedal over spring failure · da Vinci 5 systems, foot pedal component MassDevice
S3~2025Intuitive Surgical malfunction —2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures · 420.1 reports per 100,000 procedures; 3.1 deaths per 100,000 procedures, aggregate MAUDE data, most recent decade Journal of Robotic Surge
S328 Oct 2024Noah Medical recall —FDA Class II recall: Galaxy System (GAL-001). · Galaxy System (GAL-001). openFDA enforcement
S313 Aug 2024Globus Medical regulatory —FDA warns Globus Medical over QSR/MDR violations tied to ExcelsiusGPS surgical robot RAPS / MassDevice
S305 Aug 2024Quantum Surgical recall —FDA Class II recall: The EPIONE device v1.0.2 is a user controlled, stereotactic accessory · The EPIONE device v1.0.2 is a user controlled, stereotactic openFDA enforcement
S302 Aug 2024Auris Health (J&J MedTech) recall —FDA Class II recall: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. · Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005 openFDA enforcement
S308 May 2024Neuralink malfunction —Neuralink brain implant threads retract in first human patient CBS News
S315 Apr 2024Stryker Mako recall —Class II recall of Mako 3.0/3.1 software over error #3 causing loss of robotic function mid-surgery · Mako 3.0 and 3.1 software, field correction to installed base MassDevice
S309 Mar 2024Noah Medical recall —FDA Class II recall: Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) · Galaxy System REF GAL-001 (specifically GAL-019, Wired Contr openFDA enforcement
S314 Feb 2024Globus Medical recall —FDA Class II recall: ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes · ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball openFDA enforcement
S318 Oct 2023Auris Health (J&J MedTech) recall —FDA Class II recall: Monarch Platform · Monarch Platform openFDA enforcement
S315 Sep 2023Asensus Surgical recall —Class I recall of Senhance surgical robot over unintended arm movement · 5 devices in the US, distributed April-September 2023 FDA
S303 Sep 2023XACT Robotics shutdown IsraelXACT Robotics shuts down, lays off 65 · 65 employees; company shutdown Globes - Israel Business
S331 May 2023Trexo Robotics recall —FDA Class II recall: Trexo Device · Trexo Device openFDA enforcement
S4~Sep 2021Intuitive Surgical malfunction FL, USALawsuit: da Vinci surgical robot burned woman's small intestine NBC News
S309 Jul 2021Procept BioRobotics recall —FDA Class II recall: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the · AQUABEAM Handpiece, REF: HP2000, a sterile single-use compon openFDA enforcement
S326 Feb 2021Accuray recall —FDA Class II recall: CyberKnife Treatment Delivery System - Product Usage: indicated for im · CyberKnife Treatment Delivery System - Product Usage: indica openFDA enforcement
S308 Jun 2020Hocoma recall —FDA Class II recall: Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD · Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD openFDA enforcement
S329 Jul 2019Motek Medical recall —FDA Class II recall: Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mil · Body Weight Support (BWS) Light; Model No. RB011; a componen openFDA enforcement
S306 Mar 2019Procept BioRobotics recall —FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co · AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 32 openFDA enforcement
S304 Jan 2019Monteris Medical recall —Monteris Medical had a serious recall Medical Design & Outsour
S330 Mar 2018Think Surgical recall —FDA Class II recall: Think Surgical Cutter, Flat, ¿6.2mm x 144mm. · Think Surgical Cutter, Flat, ¿6.2mm x 144mm. openFDA enforcement
S4~Oct 2017Monteris Medical recall —FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for · MONTERIS MEDICAL NEUROBLATE SYSTEM, used for openFDA enforcement
S306 Dec 2016Accuray recall —FDA Class II recall: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. · CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI openFDA enforcement
S325 Jul 2016Tecan recall —FDA Class II recall: SUNRISE instrument. · SUNRISE instrument. openFDA enforcement
S304 May 2016Brainlab recall —FDA Class II recall: ExacTrac Vero is a Patient Positioning System for Radiation therapy. · ExacTrac Vero is a Patient Positioning System for Radiation openFDA enforcement
S425 Mar 2016Monteris Medical recall —FDA Class I recall: NeuroBlate System SideFire Select · NeuroBlate System SideFire Select openFDA enforcement
S329 May 2015Tecan recall —FDA Class II recall: Infinite F500, in vitro diagnostic. · Infinite F500, in vitro diagnostic. openFDA enforcement
S303 Oct 2014Monteris Medical recall —FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF: · FullFire Diffusing Tip Laser Probe, REF: openFDA enforcement
S327 Mar 2013Accuray recall —FDA Class II recall: RoboCouch Patient Positioning System · RoboCouch Patient Positioning System openFDA enforcement
S4~2013Intuitive Surgical malfunction —14-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013) · 144 deaths, 1,391 injuries, 8,061 malfunctions over 14 years, aggregate MAUDE data PLOS One
S4not documentedNeuralink fatality —Federal inquiry into Neuralink over animal deaths in implant testing The Guardian
S3not documentedIntuitive Surgical recall —Class II recall of da Vinci reusable instruments (forceps, scissors, drivers, graspers) over cable fraying · multiple instrument models, US and international distribution MedTech Dive
S4not documentedIntuitive Surgical malfunction —NBC News 10-year MAUDE analysis of da Vinci adverse events · 20,000+ adverse events, 274 deaths, 2,000+ injuries, 17,000 malfunctions, aggregate MAUDE data NBC News

Companies involved

Intuitive Surgical 8Monteris Medical 4Auris Health (J&J MedTech) 3Noah Medical 3Accuray 3Quantum Surgical 2Globus Medical 2Neuralink 2Procept BioRobotics 2Tecan 2Omnicell 1Grifols (Kiro) 1Virtual Incision 1Stryker Mako 1Asensus Surgical 1XACT Robotics 1Trexo Robotics 1Hocoma 1Motek Medical 1Think Surgical 1Brainlab 1

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