RobotRisk Autonomous Systems Incident & Risk Register
RobotRisk › Medical robotics
Industry

Medical robotics

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

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.

By submitting you agree to the privacy policy. Alerts start immediately; every email has an unsubscribe link. Filter or search the page and the alert follows your selection.

Company risk ranking

CompanyRobotRisk index (0-100)Industry percentileBandIncidents
Intuitive Surgical
74.4
 100% High 8
Auris Health (J&J MedTech)
45.7
 99% High 3
Noah Medical
45.0
 99% High 3
Omnicell
44.6
 98% Elevated 1
Quantum Surgical
38.5
 98% Elevated 2
Neuralink
37.7
 97% Elevated 2
Grifols (Kiro)
36.5
 96% Elevated 1
Globus Medical
33.6
 96% Elevated 2
Virtual Incision
28.8
 95% Elevated 1
Stryker Mako
24.9
 95% Elevated 3
Monteris Medical
24.4
 94% Elevated 4
Procept BioRobotics
22.4
 94% Elevated 2
Asensus Surgical
22.1
 92% Elevated 1
CMR Surgical
22.1
 92% Elevated 1
Trexo Robotics
22.1
 92% Elevated 1
Accuray
21.1
 91% Elevated 3
XACT Robotics
17.5
 91% Elevated 1
Hocoma
14.5
 90% Low 2
Thermo Fisher Scientific
13.8
 90% Low 1
Tecan
12.1
 89% Low 3
Motek Medical
11.6
 88% Low 1
Medtronic Hugo
11.0
 88% Low 1
Think Surgical
9.7
 87% Low 1
Keenon Robotics
6.7
 87% Low 1
Brainlab
6.6
 86% Low 1

Recent 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
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
S208 Aug 2022Stryker Mako recall —Class II recall of Mako USB converter / Polaris Spectra camera tracking hardware · Mako tracking hardware components FDA
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
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

Explore combinations

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

S3 and above (42)recall (36)
Also from Critical Systems Analysis: CSA - functional safety engineering · Company directory · FSTalent - functional safety jobs