Recall incidents

77 documented recall incidents across 43 companies.

Entries by year and severity

Most entries

S1S2S3S4S5

By incident type

By severity

By category

Sev	Date	Company	Type	Location	Incident	Source
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
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
S4	10/2017	Monteris Medical	recall	—	FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for · MONTERIS MEDICAL NEUROBLATE SYSTEM, us…	openFDA enforcement
S4	03/25 2016	Monteris Medical	recall	—	FDA Class I recall: NeuroBlate System SideFire Select · NeuroBlate System SideFire Select	openFDA enforcement
S3	07/17 2026	Zoox	recall	Las Vegas, NV, USA	Zoox issues software recall after robotaxi drove into heavy smoke	CNBC
S3	07/17 2026	Zoox	recall	USA	Zoox recalls 105 robotaxis over heavy-smoke detection failure · 105 robotaxis recalled	Reuters
S3	06/20 2026	Zoox (Amazon)	recall	USA	Zoox Autonomous Vehicle Enters Smoke-Obscured Fire Scene, Prompting Recall · 105 vehicles recalled	Reuters
S3	06/18 2026	Waymo	recall	—	Waymo recalls 3,871 robotaxis over freeway construction-zone software defect · 3,871 vehicles	The Robot Report
S3	06/16 2026	WASP	recall	—	FDA Class II recall: Brand Name: WASPLab · Brand Name: WASPLab	openFDA enforcement
S3	06/2026	Waymo	recall	USA	Waymo recalls ~4,000 robotaxis after vehicles entered closed freeway construction zones	Austin American-Statesma
S3	05/2026	Waymo	recall	USA	Waymo recalls robotaxi software over risk of driving into flooded roads	NBC 5 Dallas-Fort Worth
S3	04/20 2026	Waymo	recall	San Antonio, TX, USA	Unoccupied Waymo Robotaxi Swept Into Waterway After Entering Flooded San Antonio Road · 3,791 vehicles recalled	BBC News
S3	04/09 2026	WYBOT	recall	—	Robotic Pool Vacuum Fire Prompts CPSC Recall	Jersey Shore Online
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	12/23 2025	Zoox (Amazon)	recall	USA	Zoox recalls robotaxis for veering into oncoming traffic · 332 vehicles recalled	Reuters
S3	11/08 2025	Waymo	recall	—	Waymo recalls 3,067 vehicles for illegally passing stopped school buses · 3,067 vehicles	CBS News
S3	11/2025	Tesla Energy	recall	USA	Tesla recalls Powerwall 2 AC battery systems over fire/burn risk · ~10,500 units	U.S. Consumer Product Sa
S3	09/12 2025	Rivian	recall	USA	Rivian recalls 24,000 EVs over software glitch that can increase crash risk	New York Post
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	05/2025	Zoox	recall	Las Vegas, NV, USA	Zoox issues software recall after Las Vegas robotaxi crash	NBC News
S3	05/2025	Waymo	recall	—	Waymo recalls 1,212 robotaxis over collisions with gates and chains · 1,212 vehicles	InsideEVs
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	04/08 2025	Zoox	recall	—	Zoox recalls approximately 270 vehicles after intersection collision · approx. 270 vehicles	Zoox safety recall repor
S3	04/03 2025	Wandercraft	recall	—	FDA Class II recall: Atalante X, Powered Exoskeleton. · Atalante X, Powered Exoskeleton.	openFDA enforcement
S3	03/26 2025	Trimble	recall	—	FDA Class II recall: The Trimble RTS873 robotic total station is a solution designed for co · The Trimble RTS873 robotic total stati…	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	10/28 2024	Noah Medical	recall	—	FDA Class II recall: Galaxy System (GAL-001). · Galaxy System (GAL-001).	openFDA enforcement
S3	08/09 2024	Cruise (GM)	recall	USA	GM's Cruise recalls entire robotaxi fleet over unexpected braking	Wards Auto
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	05/21 2024	Waymo	recall	Phoenix, AZ, USA	Waymo recalls ~672 robotaxis after utility pole collision · 672 vehicles	jidounten-lab.com
S3	05/21 2024	Waymo	recall	Phoenix, AZ, USA	Waymo recalls robotaxis after collision with utility pole · fleet-wide software update	TechCrunch
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	02/2024	Waymo	recall	—	Waymo recalls 444 vehicles over towed-vehicle detection issue · 444 vehicles	NBC News
S3	12/13 2023	Tesla	recall	—	NHTSA recall of over 2 million Tesla vehicles for inadequate Autopilot driver monitoring · over 2,000,000 vehicles	Wikipedia
S3	11/08 2023	Cruise	recall	—	Cruise recalls 950 robotaxis via software update after pedestrian dragging · 950 vehicles	The Verge
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	08/24 2023	Aiper	recall	USA	Aiper Elite Pro Cordless Robotic Pool Vacuum Cleaners Recalled for Burn/Fire Hazard · ~22,000 units	KIRO 7 News Seattle / AB
S3	05/31 2023	Trexo Robotics	recall	—	FDA Class II recall: Trexo Device · Trexo Device	openFDA enforcement
S3	03/16 2023	STIHL	recall	—	STIHL Recalls Docking Stations Sold with iMOW Robotic Lawn Mowers Due to Fire Hazard	USA Today / CPSC
S3	03/08 2022	Pony.AI	recall	—	NHTSA announces first-ever recall of an automated driving system, targeting Pony.ai · software recall, Pony.ai test fleet	Reuters
S3	02/17 2022	Husqvarna	recall	—	Husqvarna recalls Automower 435X AWD and 535 AWD robotic mowers for battery fire hazard · ~1,400 units	CPSC
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	05/08 2021	Hitachi Rail	recall	—	Class 800/385 fleet withdrawn UK-wide after underframe cracks found · fleet-wide (dozens of trainsets), mult…	BBC News
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	12/21 2020	iRobot	recall	—	iRobot Clean Base for Roomba i7+ recalled in Canada over electrical short hazard · 11,971 units (Canada)	Health Canada / Recalls.
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
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
S3	03/24 2017	Kalmar	recall	—	Kalmar terminal tractor recall - electrical fire risk from ground cable/PDC wiring defects · Kalmar terminal tractors/vehicles, mul…	Transport Canada Vehicle
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
S3	05/29 2015	Tecan	recall	—	FDA Class II recall: Infinite F500, in vitro diagnostic. · Infinite F500, in vitro diagnostic.	openFDA enforcement
S3	10/03 2014	Monteris Medical	recall	—	FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF: · FullFire Diffusing Tip Laser Probe, RE…	openFDA enforcement
S3	03/27 2013	Accuray	recall	—	FDA Class II recall: RoboCouch Patient Positioning System · RoboCouch Patient Positioning System	openFDA enforcement
S3	04/25 2008	Zucchetti Centro Sistemi	recall	—	CPSC recall: LawnBott robotic lawn mowers (laceration hazard) · LawnBott robotic mowers	CPSC
S3		Tesla Energy	recall	Australia	Tesla Powerwall 2 battery recall in Australia over overheating/fire risk	7NEWS
S3		Tesla	recall	—	NHTSA forces recall of 362,758 Full Self-Driving Beta vehicles · 362,758 vehicles	PBS NewsHour
S3		Lely	recall	—	Lely settles Astronaut A4 robotic milking system defect class action for ~$122M · ~$122M settlement	brownfieldagnews.com
S3		LG Energy Solution	recall	—	LG Energy Solution recalls home/ESS batteries after thermal events, one injury · US residential ESS recall, ~$350M cost	EnergyTrend
S3		Kalmar	recall	—	Kalmar Ottawa T2 terminal tractor recall - cab tilt cylinder failure risk · Kalmar Ottawa T2 terminal tractors, 20…	NHTSA Recall Report 23V0
S3		Intuitive Surgical	recall	—	Class II recall of da Vinci reusable instruments (forceps, scissors, drivers, graspers) over cable fraying · multiple instrument models, US and int…	MedTech Dive
S3		Blue Solutions	recall	Germany	Mercedes-Benz eCitaro Buses With Solid-State Batteries Recalled · multiple eCitaro buses	InsideEVs
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
S2	12/23 2025	Zoox (Amazon)	recall	USA	Zoox Recalls 332 Robotaxis After Lane-Crossing Software Error · 332 vehicles recalled	Reuters
S2	12/23 2025	Zoox	recall	USA	Zoox robotaxi crosses into opposing lane, prompts 332-vehicle recall · Vehicles later recalled: 332	Reuters
S2	08/08 2022	Stryker Mako	recall	—	Class II recall of Mako USB converter / Polaris Spectra camera tracking hardware · Mako tracking hardware components	FDA
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
S2	11/10 2014	Tecan	recall	—	FDA Class III recall: Infinite 200PRO · Infinite 200PRO	openFDA enforcement
S1	08/19 2024	Kinova Robotics	recall	—	Kinova Jaco assistive robotic arm - FDA Class I correction for fire/burn hazard · All lots/serial numbers of affected Ja…	FDA Medical Device Recal

Companies with recall incidents

Also from Critical Systems Analysis: CSA - functional safety engineering · Company directory · FSTalent - functional safety jobs