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Medical robotics · recall incidents

36 documented incidents where industry is Medical robotics and type is recall, across 19 companies, 2013-2026. Every row cites its source; severity runs S1 (near miss) to S5 (fatal or catastrophic). Entity pages: Medical robotics · recall.

36Unique incidents
19Companies involved
S5Highest severity
83%Verified
86%From regulators
2013-2026Years covered

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Incident list

SevDateCompanyTypeLocationIncidentSource
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
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
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
S328 Oct 2024Noah Medical recall —FDA Class II recall: Galaxy System (GAL-001). · Galaxy System (GAL-001). openFDA enforcement
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
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
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
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
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
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

Companies involved

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

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