RobotRisk Autonomous Systems Incident & Risk Register
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Industry

Medical robotics

274 tracked companies; 25 companies with incident history, 50 unique documented incidents. Ranked by RobotRisk index; tick marks the industry median across companies with documented incidents, where nonzero. All industries.

21.8/100Median index across the 25 Medical robotics companies with incident history (274 tracked, 249 with none)
25Companies with incident history
50Unique documented incidents
S5Highest severity on file

Analyst brief

Three entities appear in this category: Asensus Surgical (Class I recall, unintended arm movement), Trexo Robotics (Class II recall, pediatric gait device), and XACT Robotics (company shutdown, not a safety incident). The dominant recorded failure mode among the safety-relevant entries is unintended device motion addressed through FDA recall action, with Asensus's Class I designation marking the most severe finding in the category. The record shows a regulator-driven pattern for two of three entities, with recall severity varying by FDA class, alongside one unrelated business-continuity event. No single entity dominates by incident count; each contributes one distinct event.

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Company risk ranking

Index 0-100: each documented incident is weighted by severity and by how well-sourced it is, discounted as it ages (half its weight every 3 years), then summed per company and scaled on a log curve so the highest-risk company worldwide is 100. Rank in industry: position among companies in the same industry that have at least one documented incident. Band groups the index: Critical (75+), High (45-74), Elevated (15-44), Low (under 15 with at least one incident); None documented means no public incident was found, which is not proof of safety.

CompanyRobotRisk index (0-100)Rank in industryBandIncidents
Intuitive Surgical
72.6
 1 of 25 High 8
Auris Health (J&J MedTech)
45.4
 2 of 25 High 3
Noah Medical
44.7
 3 of 25 Elevated 3
Omnicell
44.2
 4 of 25 Elevated 1
Quantum Surgical
38.1
 5 of 25 Elevated 2
Grifols (Kiro)
36.2
 6 of 25 Elevated 1
Neuralink
35.0
 7 of 25 Elevated 2
Globus Medical
33.3
 8 of 25 Elevated 2
Virtual Incision
28.5
 9 of 25 Elevated 1
Stryker Mako
24.6
 10 of 25 Elevated 3
Monteris Medical
24.1
 11 of 25 Elevated 4
Procept BioRobotics
22.1
 12 of 25 Elevated 2
Asensus Surgical
21.8
 13 of 25 Elevated 1
CMR Surgical
21.8
 14 of 25 Elevated 1
Trexo Robotics
21.8
 15 of 25 Elevated 1
Accuray
20.8
 16 of 25 Elevated 3
XACT Robotics
17.3
 17 of 25 Elevated 1
Medtronic Hugo
14.7
 18 of 25 Low 1
Hocoma
14.2
 19 of 25 Low 2
Thermo Fisher Scientific
13.6
 20 of 25 Low 1
Tecan
11.9
 21 of 25 Low 3
Motek Medical
11.4
 22 of 25 Low 1
Think Surgical
9.5
 23 of 25 Low 1
Brainlab
6.5
 24 of 25 Low 1
Keenon Robotics
6.5
 25 of 25 Low 1

Also active in Medical robotics

Companies filed under another industry that also ship Medical robotics products.

Ageless Innovation Consumer roboticsAlt-Bionics Humanoid robotsAndromeda Robotics Consumer roboticsAnybots Consumer roboticsAsimov Robotics Humanoid robotsAva Robotics Consumer roboticsAwabot Consumer roboticsAXYN Robotique Consumer roboticsBionIT Labs Humanoid robotsBotzee AMR / mobile robotCarale AMR / mobile robotCity Robotics AMR / mobile robotCT Asia Robotics Consumer roboticsDeliverz.ai AMR / mobile robotDouble Robotics Consumer roboticsEssential Robotics AMR / mobile robotFloorBotics AMR / mobile robotFoxconn (Hon Hai) Humanoid robotsFuji Soft (Palro) Consumer roboticsFybots AMR / mobile robotGoBe Robots Consumer roboticsGwell (Mrobot) AMR / mobile robotHaystack Robotics AMR / mobile robotHyodol Consumer roboticsIntuition Robotics Consumer roboticsiPresence (kubi) Consumer roboticsKompai Robotics Consumer roboticsKompaï Robotics Consumer roboticsLoop Robots AMR / mobile robotMachani Robotics Humanoid robotsMand.ro Humanoid robotsMelco Mobility Solutions AMR / mobile robotMilo X Robotics AMR / mobile robotNoah Robotics AMR / mobile robotNovaticLab AMR / mobile robotOTSAW AMR / mobile robotOYMotion Humanoid robotsPadbot (Inbot) Consumer roboticsPARO Robots Consumer roboticsRayTron Consumer roboticsReeman Consumer roboticsRobocare Consumer roboticsRobotemi Consumer roboticsRobotise AMR / mobile robotTechmetics Robotics AMR / mobile robotTelelift AMR / mobile robotTMiRob AMR / mobile robottmsuk Humanoid robotsTorooc Consumer roboticsugo Consumer roboticsUnited Robotics Group AMR / mobile robotUnited Robots AMR / mobile robotUnlimited Robotics Humanoid robots

Incidents

50 of 50 incidents
SevDateCompanyTypeLocationIncidentSource
S104 Aug 2026Thermo Fisher Scientific cyber WorldwideCISA publishes Thermo Fisher Applied Biosystems genetic analyzer advisory · multiple Applied Biosystems analyzer software versions CISA ICS medical advisor
S209 Jun 2026CMR Surgical recall —Class II recall of Versius surgeon console over disabled Secure Boot cybersecurity control · 2 units distributed in the US (California) FDA
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
S1~Mar 2026Keenon Robotics malfunction RestaurantRestaurant service robot malfunctions, scatters tableware Fox Business
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
S2~Jun 2025Medtronic Hugo malfunction —Field safety notice for Hugo surgeon console power supply failure · 25 complaints, subset of Hugo consoles in Europe MassDevice
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
S319 Dec 2024Intuitive 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
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
S208 Aug 2022Stryker Mako recall —Class II recall of Mako USB converter / Polaris Spectra camera tracking hardware · Mako tracking hardware components FDA
S4~2022Neuralink fatality —Federal inquiry into Neuralink over animal deaths in implant testing The Guardian
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
S419 Dec 2018Intuitive 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
S2~Jul 2018Stryker Mako recall —Stryker Mako Restoris MCK knee implant lawsuit removed to federal court (Perry v. Stryker/Mako) · individual implant failure, part of broader MCK litigation AboutLawsuits.com
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
S230 Jun 2015Hocoma injury —Proximal tibia fracture in a patient with incomplete spinal cord injury associated with robotic treadmill training · 1 patient nature.com
S329 May 2015Tecan recall —FDA Class II recall: Infinite F500, in vitro diagnostic. · Infinite F500, in vitro diagnostic. openFDA enforcement
S210 Nov 2014Tecan recall —FDA Class III recall: Infinite 200PRO · Infinite 200PRO 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

Explore combinations

Pre-built views of these incidents by a second dimension.

S3 and above (42)recall (36)
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