RobotRisk / medical robotics

Medical Robotics

162 companies tracked, 23 with documented incidents. Ranked by RobotRisk index; tick marks category median where nonzero.

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.

Entries by year and severity

S1S2S3S4S5

By incident type

By severity

Highest-index companies

Company risk ranking

Company	RobotRisk index (0-100)	Category percentile	Band	Incidents
Intuitive Surgical	100.0	100%	Critical	1657
Stryker Mako	65.3	99%	High	135
Medtronic Hugo	55.7	99%	High	40
Asensus Surgical	38.6	98%	Elevated	16
CMR Surgical	29.6	98%	Elevated	4
Auris Health (J&J MedTech)	27.4	97%	Elevated	3
Noah Medical	27.0	96%	Elevated	3
Omnicell	26.7	96%	Elevated	1
Quantum Surgical	23.1	95%	Elevated	2
Neuralink	22.6	94%	Elevated	2
Globus Medical	20.2	94%	Elevated	2
Virtual Incision	17.3	93%	Elevated	1
Monteris Medical	14.6	92%	Low	4
Procept BioRobotics	13.5	92%	Low	2
Trexo Robotics	13.2	91%	Low	1
Accuray	12.6	91%	Low	3
XACT Robotics	10.5	90%	Low	1
Hocoma	8.7	89%	Low	2
Tecan	7.3	89%	Low	3
Motek Medical	7.0	88%	Low	1
Think Surgical	5.8	88%	Low	1
Brainlab	4.0	86%	Low	1
Keenon Robotics	4.0	87%	Low	1
Distalmotion	0.0	0%	None documented	0
Labrador Systems	0.0	0%	None documented	0
Moon Surgical	0.0	0%	None documented	0
Vicarious Surgical	0.0	0%	None documented	0
Medicaroid Corporation	0.0	0%	None documented	0
Momentis Surgical	0.0	0%	None documented	0
Memic Innovative Surgery	0.0	0%	None documented	0
Meere Company	0.0	0%	None documented	0
Microbot Medical	0.0	0%	None documented	0
Corindus (Siemens Healthineers)	0.0	0%	None documented	0
Venus Concept (ARTAS)	0.0	0%	None documented	0
Preceyes	0.0	0%	None documented	0
Forsight Robotics	0.0	0%	None documented	0
avateramedical	0.0	0%	None documented	0
Medical Microinstruments (MMI)	0.0	0%	None documented	0
Precision Robotics (HK)	0.0	0%	Not yet assessed	0
Human Xtensions	0.0	0%	Not yet assessed	0
MicroPort MedBot	0.0	0%	None documented	0
SS Innovations	0.0	0%	None documented	0
Freehand 2010 Ltd	0.0	0%	None documented	0
Riverfield Inc	0.0	0%	None documented	0
Robocath	0.0	0%	None documented	0
Virtuoso Surgical	0.0	0%	None documented	0
Zimmer Biomet	0.0	0%	None documented	0
Smith+Nephew	0.0	0%	None documented	0
Monogram Orthopaedics	0.0	0%	None documented	0
Curexo	0.0	0%	None documented	0
Corin Group	0.0	0%	None documented	0
TINAVI Medical Technologies	0.0	0%	None documented	0
Renishaw	0.0	0%	None documented	0
ClearPoint Neuro	0.0	0%	None documented	0
Synaptive Medical	0.0	0%	None documented	0
Axilum Robotics	0.0	0%	None documented	0
Interventional Systems	0.0	0%	None documented	0
Perfint Healthcare	0.0	0%	None documented	0
EndoQuest Robotics	0.0	0%	None documented	0
Ekso Bionics	0.0	0%	None documented	0
ReWalk Robotics	0.0	0%	None documented	0
Cyberdyne Inc	0.0	0%	None documented	0
Myomo	0.0	0%	None documented	0
B-Temia	0.0	0%	None documented	0
Gogoa Mobility Robots	0.0	0%	None documented	0
Reha Technology	0.0	0%	None documented	0
Tyromotion	0.0	0%	None documented	0
Motorika	0.0	0%	None documented	0
Swisslog Healthcare	0.0	0%	None documented	0
Aeolus Robotics	0.0	0%	None documented	0
UVD Robots	0.0	0%	None documented	0
Xenex Disinfection Services	0.0	0%	None documented	0
ScriptPro	0.0	0%	None documented	0
ARxIUM	0.0	0%	None documented	0
Yuyama Co.	0.0	0%	None documented	0
Willach Group	0.0	0%	None documented	0
Kirby Lester	0.0	0%	None documented	0
BD Rowa	0.0	0%	None documented	0
Hamilton Company	0.0	0%	None documented	0
Opentrons	0.0	0%	None documented	0
Levita Magnetics	0.0	0%	None documented	0
Lifeward (ReWalk Robotics)	0.0	0%	None documented	0
Angel Robotics	0.0	0%	None documented	0
Marsi Bionics	0.0	0%	None documented	0
ExoAtlet	0.0	0%	None documented	0
Parata Systems	0.0	0%	None documented	0
Grifols (Kiro)	0.0	0%	None documented	0
Becton Dickinson (BD Rowa)	0.0	0%	None documented	0
Beckman Coulter	0.0	0%	None documented	0
Thermo Fisher Scientific	0.0	0%	None documented	0
Revvity	0.0	0%	None documented	0
Azenta Life Sciences	0.0	0%	None documented	0
Hudson Robotics	0.0	0%	None documented	0
Chemspeed Technologies	0.0	0%	None documented	0
Automata	0.0	0%	None documented	0
Arctoris	0.0	0%	None documented	0
Bionik Laboratories	0.0	0%	None documented	0
Rex Bionics	0.0	0%	None documented	0
Bioservo Technologies	0.0	0%	None documented	0
Roam Robotics	0.0	0%	None documented	0
Ottobock	0.0	0%	None documented	0
Focal Meditech	0.0	0%	None documented	0
Rehab-Robotics Company Limited	0.0	0%	None documented	0
Bioxtreme	0.0	0%	None documented	0
Barrett Technology	0.0	0%	None documented	0
Cionic	0.0	0%	None documented	0
Parker Hannifin (Indego)	0.0	0%	None documented	0
SuitX (US Bionics)	0.0	0%	None documented	0
Myolyn	0.0	0%	Not yet assessed	0
BionicM	0.0	0%	Not yet assessed	0
Neofect	0.0	0%	None documented	0
Motus Nova	0.0	0%	Not yet assessed	0
MyoSwiss	0.0	0%	Not yet assessed	0
EQUASHIELD	0.0	0%	None documented	0
Talyst	0.0	0%	Not yet assessed	0
JVM Co., Ltd.	0.0	0%	None documented	0
Deenova	0.0	0%	Not yet assessed	0
Tosho Inc.	0.0	0%	Not yet assessed	0
Pearson Medical Technologies	0.0	0%	Not yet assessed	0
RxSafe	0.0	0%	None documented	0
Inpeco	0.0	0%	None documented	0
Copan Diagnostics	0.0	0%	None documented	0
Qiagen	0.0	0%	None documented	0
Sysmex Corporation	0.0	0%	None documented	0
Roche Diagnostics	0.0	0%	None documented	0
Abbott	0.0	0%	None documented	0
Agilent Technologies	0.0	0%	None documented	0
Gilson Inc.	0.0	0%	None documented	0
Eppendorf	0.0	0%	None documented	0
SPT Labtech	0.0	0%	None documented	0
Formulatrix	0.0	0%	None documented	0
Zinsser Analytic	0.0	0%	None documented	0
Aurora Biomed	0.0	0%	None documented	0
Biosero	0.0	0%	None documented	0
HighRes Biosolutions	0.0	0%	None documented	0
Dynamic Devices	0.0	0%	None documented	0
Labman Automation	0.0	0%	None documented	0
Analytik Jena	0.0	0%	None documented	0
Andrew Alliance	0.0	0%	None documented	0
Randox Laboratories	0.0	0%	None documented	0
BioNex Solutions	0.0	0%	None documented	0
bioMerieux	0.0	0%	None documented	0
QuidelOrtho	0.0	0%	None documented	0
Werfen	0.0	0%	None documented	0
Mindray	0.0	0%	None documented	0
AiM Medical Robotics	0.0	0%	Not yet assessed	0
Stereotaxis	0.0	0%	None documented	0
Insightec	0.0	0%	None documented	0
EDAP TMS	0.0	0%	None documented	0
Profound Medical	0.0	0%	None documented	0
Elekta	0.0	0%	None documented	0
Deerfield Imaging (IMRIS)	0.0	0%	Not yet assessed	0
Galen Robotics	0.0	0%	Not yet assessed	0
Brain Navi Biotechnology	0.0	0%	Not yet assessed	0
Beijing Baihui Weikang Technology (Remebot)	0.0	0%	Not yet assessed	0
Point Robotics	0.0	0%	Not yet assessed	0
Varian Medical Systems	0.0	0%	None documented	0
Neocis	0.0	0%	None documented	0
Beijing Yakebot Technology (Yakebot)	0.0	0%	None documented	0
Perceptive	0.0	0%	None documented	0
Acusurgical	0.0	0%	None documented	0
Ophthorobotics	0.0	0%	None documented	0

Recent incidents

Sev	Date	Company	Type	Location	Incident	Source
S2	06/09 2026	CMR Surgical	recall	—	Class II recall of Versius surgeon console over disabled Secure Boot cybersecurity control · 2 units distributed in the US (Califor…	FDA
S4	03/25 2026	Omnicell	recall	—	FDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station. · Rolls of label stock used with the Omn…	openFDA enforcement
S5	03/11 2026	Intuitive Surgical	recall	—	Class I recall of da Vinci SureForm stapler reloads after patient death · 1 death, 4 serious injuries; recall of…	FDA
S1	03/2026	Keenon Robotics	malfunction	Restaurant	Restaurant service robot malfunctions, scatters tableware	Fox Business
S3	01/21 2026	Auris Health (J&J MedTech)	recall	—	FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0 · MONARCH Platform, Bronchoscopy, Catalo…	openFDA enforcement
S3	09/12 2025	Noah Medical	recall	—	FDA Class II recall: Brand Name: Galaxy System · Brand Name: Galaxy System	openFDA enforcement
S3	05/23 2025	Quantum Surgical	recall	—	FDA Class II recall: EPIONE Model 30-0001 · EPIONE Model 30-0001	openFDA enforcement
S3	04/23 2025	Virtual Incision	recall	—	FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur · MIRA SURGICAL SYSTEM, Table mounted mi…	openFDA enforcement
S3	02/26 2025	Intuitive Surgical	recall	—	Class II recall of da Vinci 5 foot pedal over spring failure · da Vinci 5 systems, foot pedal compone…	MassDevice
S3	2025	Intuitive Surgical	malfunction	—	2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures · 420.1 reports per 100,000 procedures; …	Journal of Robotic Surge
S3	10/28 2024	Noah Medical	recall	—	FDA Class II recall: Galaxy System (GAL-001). · Galaxy System (GAL-001).	openFDA enforcement
S3	08/13 2024	Globus Medical	regulatory	—	FDA warns Globus Medical over QSR/MDR violations tied to ExcelsiusGPS surgical robot	RAPS / MassDevice
S3	08/05 2024	Quantum 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 con…	openFDA enforcement
S3	08/02 2024	Auris Health (J&J MedTech)	recall	—	FDA Class II recall: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. · Monarch Platform (Endoscopy), REF: MON…	openFDA enforcement
S3	05/08 2024	Neuralink	malfunction	—	Neuralink brain implant threads retract in first human patient	CBS News
S3	04/15 2024	Stryker 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 corre…	MassDevice
S3	03/09 2024	Noah Medical	recall	—	FDA Class II recall: Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) · Galaxy System REF GAL-001 (specificall…	openFDA enforcement
S3	02/14 2024	Globus Medical	recall	—	FDA Class II recall: ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes · ExcelsiusGPS Cannula A, 9mm x 250mm, C…	openFDA enforcement
S3	10/18 2023	Auris Health (J&J MedTech)	recall	—	FDA Class II recall: Monarch Platform · Monarch Platform	openFDA enforcement
S3	09/15 2023	Asensus Surgical	recall	—	Class I recall of Senhance surgical robot over unintended arm movement · 5 devices in the US, distributed April…	FDA
S3	09/03 2023	XACT Robotics	shutdown	Israel	XACT Robotics shuts down, lays off 65 · 65 employees; company shutdown	Globes - Israel Business
S3	05/31 2023	Trexo Robotics	recall	—	FDA Class II recall: Trexo Device · Trexo Device	openFDA enforcement
S2	08/08 2022	Stryker Mako	recall	—	Class II recall of Mako USB converter / Polaris Spectra camera tracking hardware · Mako tracking hardware components	FDA
S4	09/2021	Intuitive Surgical	malfunction	FL, USA	Lawsuit: da Vinci surgical robot burned woman's small intestine	NBC News
S3	07/09 2021	Procept BioRobotics	recall	—	FDA Class II recall: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the · AQUABEAM Handpiece, REF: HP2000, a ste…	openFDA enforcement
S3	02/26 2021	Accuray	recall	—	FDA Class II recall: CyberKnife Treatment Delivery System - Product Usage: indicated for im · CyberKnife Treatment Delivery System -…	openFDA enforcement
S3	06/08 2020	Hocoma	recall	—	FDA Class II recall: Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD · Lokomat Pro, Catalog Numbers 30003 Lok…	openFDA enforcement
S3	07/29 2019	Motek 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…	openFDA enforcement
S3	03/06 2019	Procept BioRobotics	recall	—	FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co · AquaBeam Handpiece, Sterile EO, Rx Onl…	openFDA enforcement
S3	01/04 2019	Monteris Medical	recall	—	Monteris Medical had a serious recall	Medical Design & Outsour
S2	07/2018	Stryker Mako	recall	—	Stryker Mako Restoris MCK knee implant lawsuit removed to federal court (Perry v. Stryker/Mako) · individual implant failure, part of br…	AboutLawsuits.com
S3	03/30 2018	Think Surgical	recall	—	FDA Class II recall: Think Surgical Cutter, Flat, ¿6.2mm x 144mm. · Think Surgical Cutter, Flat, ¿6.2mm x …	openFDA enforcement
S4	10/2017	Monteris Medical	recall	—	FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for · MONTERIS MEDICAL NEUROBLATE SYSTEM, us…	openFDA enforcement
S3	12/06 2016	Accuray	recall	—	FDA Class II recall: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. · CyberKnife Robotic Radiosurgery System…	openFDA enforcement
S3	07/25 2016	Tecan	recall	—	FDA Class II recall: SUNRISE instrument. · SUNRISE instrument.	openFDA enforcement
S3	05/04 2016	Brainlab	recall	—	FDA Class II recall: ExacTrac Vero is a Patient Positioning System for Radiation therapy. · ExacTrac Vero is a Patient Positioning…	openFDA enforcement
S4	03/25 2016	Monteris Medical	recall	—	FDA Class I recall: NeuroBlate System SideFire Select · NeuroBlate System SideFire Select	openFDA enforcement
S2	06/30 2015	Hocoma	injury	—	Proximal tibia fracture in a patient with incomplete spinal cord injury associated with robotic treadmill training · 1 patient	nature.com
S3	05/29 2015	Tecan	recall	—	FDA Class II recall: Infinite F500, in vitro diagnostic. · Infinite F500, in vitro diagnostic.	openFDA enforcement
S2	11/10 2014	Tecan	recall	—	FDA Class III recall: Infinite 200PRO · Infinite 200PRO	openFDA enforcement

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