Surgical robots incidents

125 verified incidents involving surgical robots robots. Source-attributed, append-only, corrections recorded on the record.

• FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches2026-07-23 · regulatory_action
• FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures2026-07-22 · regulatory_action
• FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries2026-07-22 · regulatory_action
• FDA grants De Novo marketing authorization to J&J Ottava surgical robot2026-07-22 · regulatory_action
• FDA clears J&J Ottava surgical robot for US launch following de novo submission2026-07-22 · regulatory_action
• LEM Surgical receives FDA clearance for Dynamis multi-arm surgical robot2026-07-01 · regulatory_action
• Medtronic Hugo surgical robot earns FDA clearance for additional indication2026-07-01 · regulatory_action
• FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures2026-07-01 · regulatory_action
• ROBODOC Surgical System receives FDA 510(k) marketing clearance2026-06-30 · regulatory_action
• LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system2026-06-23 · regulatory_action
• Intuitive Surgical recalls da Vinci SP1098 instrument2026-06-22 · recall
• Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications2026-06-15 · regulatory_action
• THINK Surgical receives FDA 510(k) clearance for TMINI 1.12026-06-15 · regulatory_action
• FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly2026-06-15 · recall
• Revolve Surgical receives FDA 510(k) clearance for surgical robot platform2026-06-15 · regulatory_action
• CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability2026-06-09 · recall
• Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death2026-05-28 · recall
• Medtronic Hugo RAS: failure to calibrate with the application program freezing or failing to launch (FDA MAUDE)2026-05-21 · malfunction
• Medtronic Hugo RAS: unintended collision with the application program freezing or failing to launch (FDA MAUDE)2026-05-14 · malfunction
• Medtronic Hugo RAS: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)2026-05-11 · injury
• THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment2026-05-08 · recall
• Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)2026-05-08 · malfunction
• Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)2026-04-30 · injury
• Intuitive Surgical recalls da Vinci staplers after death and injuries2026-04-15 · recall
• CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)2026-04-07 · malfunction
• FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab2026-04-06 · regulatory_action
• Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)2026-04-02 · recall
• Sunnybrook study: robotic-assisted knee replacement associated with double the risk of major complications2026-04-01 · other
• Zimmer ROSA Recon: force sensor error and unintended robotic-arm drift during a knee case (FDA MAUDE)2026-04-01 · malfunction
• Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments2026-03-31 · regulatory_action
• Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers2026-03-26 · regulatory_action
• Intuitive Surgical administrative network breached via phishing; employee and customer data compromised2026-03-16 · other
• CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery2026-03-15 · regulatory_action
• da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)2026-03-11 · recall
• Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines2026-03-11 · recall
• Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death2026-03-11 · recall
• Zimmer ROSA Recon: a large amount of sparks with a hole found in the power cord (FDA MAUDE)2026-03-09 · malfunction
• FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field2026-02-18 · recall
• Medtronic Hugo robotic surgery system cleared by FDA for urologic procedures2026-02-15 · regulatory_action
• AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect2026-02-04 · regulatory_action
• da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use2026-02-02 · recall
• Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)2026-01-28 · recall
• Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures2026-01-26 · regulatory_action
• Auris Health (J&J) recalls Monarch over unanticipated robotic arm positioning toward patient-left2026-01-21 · recall
• Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)2026-01-16 · malfunction
• Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification2026-01-07 · regulatory_action
• Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel2025-12-20 · fatality
• FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))2025-12-17 · regulatory_action
• FDA clears CMR Surgical Versius Plus robotic surgical system via 510(k) for cholecystectomy2025-12-16 · regulatory_action
• Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility2025-12-15 · recall
• Intuitive recalls da Vinci S/Si Mega Needle Driver over broken or frayed grip cables2025-12-09 · recall
• Intuitive recalls da Vinci S/Si Permanent Cautery Hook over frayed or broken pitch cables2025-12-09 · recall
• FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures2025-12-03 · regulatory_action
• Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display2025-11-17 · recall
• da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use2025-11-07 · recall
• Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use2025-11-07 · recall
• Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results2025-10-18 · recall
• FDA clears Intuitive Surgical Ion software upgrade with AI-powered navigation and advanced imaging for lung biopsy2025-10-08 · regulatory_action
• Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system2025-09-08 · regulatory_action
• da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)2025-06-18 · injury
• Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)2025-04-01 · malfunction
• FDA clears Quantum Surgical Epione robot for abdominal tumor ablation2025-03-26 · regulatory_action
• da Vinci 5 console foot-pedal recall over a spring failure that can leave a pedal stuck pressed2025-02-26 · recall
• da Vinci endoscope: light left on burned the patient after resting on the thigh (FDA MAUDE)2025-01-21 · injury
• Intuitive recalls da Vinci 8mm Horizon Small Clip Applier over frayed or broken grip cables2024-12-19 · recall
• Intuitive recalls da Vinci 8mm Large Needle Driver over frayed or broken grip cables2024-12-19 · recall
• Intuitive recalls da Vinci 8mm ProGrasp Forceps over frayed or broken grip cables2024-12-19 · recall
• Intuitive recalls da Vinci 8mm Mega SutureCut Needle Driver over frayed or broken grip cables2024-12-19 · recall
• Intuitive recalls da Vinci Monopolar Curved Scissors over frayed/broken grip cables causing loss of instrument control2024-12-19 · recall
• Intuitive Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)2024-09-04 · recall
• Intuitive Surgical recalls 144 da Vinci 5 systems over surgeon console motor connector failure2024-08-21 · recall
• Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)2024-08-15 · malfunction
• Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts2024-08-07 · recall
• FDA Class 2 recall of Epione needle guide component due to rust2024-08-05 · recall
• Auris Health (J&J) recalls Monarch over a power-cord strain-relief electrical short2024-08-02 · recall
• Zimmer ROSA Recon: reaming produced an oblong hole requiring a bone graft (FDA MAUDE)2024-06-24 · injury
• Stryker Mako Total Knee software correction over 'error #3' codes when switching applications2024-05-28 · recall
• FDA MAUDE report: Yomi guided dental implant robot serious injury event2024-01-01 · injury
• Patient death during Epione-assisted liver cancer ablation procedure in France2023-11-10 · fatality
• Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view2023-10-18 · recall
• Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement2023-10-06 · recall
• Asensus Senhance Class I recall: software malfunction caused uncontrolled arm motion after disengaging teleop2023-09-15 · recall
• Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion2023-09-15 · recall
• Intuitive recalls da Vinci Tip-Up Fenestrated Grasper over grip breakage that can drop steel fragments into patients2023-06-12 · recall
• Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking2023-03-10 · recall
• da Vinci X/Xi recall: loose instrument carriage from an out-of-spec linear-rail component2023-02-23 · recall
• da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments2022-10-07 · recall
• Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments2022-09-20 · recall
• FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system2022-08-23 · regulatory_action
• Stryker Mako bone-registration accuracy recall (Class II, 2022)2022-07-01 · recall
• Intuitive recalls da Vinci X/Xi and S/Si Clip Appliers over unexpected motion from partial disengagement2022-07-01 · recall
• Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding2022-03-17 · recall
• Intuitive recalls da Vinci EndoWrist Vessel Sealer Extend instruments over risk of insufficient vessel seals2022-03-03 · recall
• Intuitive recalls da Vinci SynchroSeal instruments over risk of insufficient vessel seals2022-03-03 · recall
• Intuitive recalls da Vinci Xi/X Conductive Cannula Reducer over metal tip that can dislodge inside patients2021-12-23 · recall
• Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory2021-09-22 · recall
• Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft2021-08-06 · recall
• Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)2020-12-02 · recall
• Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)2020-11-11 · injury
• Intuitive recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged2020-10-23 · recall
• Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts2020-10-23 · recall
• Intuitive recalls Ion Catheter Reprocessing Cover over disengagement that can retain cleaning chemicals2020-06-10 · recall
• Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory2019-09-10 · recall
• Intuitive recalls da Vinci X and Xi systems over defective capacitors that can cause vision loss or system errors2019-07-26 · recall
• Brainlab recalls spine 3D navigation software for incorrect display2019-07-10 · recall
• Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage2019-04-19 · recall
• Intuitive recalls da Vinci 8mm Monopolar Curved Scissors over extension-tube cracks that can drop fragments into patients2018-08-15 · recall
• Intuitive recalls da Vinci X systems over a high rate of ACJ board failure2018-03-07 · recall
• Stryker recalls Mako RIO over loss of system power mid-procedure2017-06-07 · recall
• Zimmer Biomet recalls ROSA Spine 1.0.2 over the robotic arm being sent to the wrong position2017-05-01 · recall
• Zimmer Biomet recalls ROSA Brain 3.0 over the robotic arm being sent to the wrong position2017-05-01 · recall
• Intuitive recalls da Vinci Xi EndoWrist Suction Irrigator over unexpected arm motion in specific software scenarios2017-03-31 · recall
• Zimmer Biomet recalls ROSA Brain 3.0.0 over the head holder connector locking up when tightened2016-10-11 · recall
• Intuitive recalls da Vinci EndoWrist Stapler 45 over increased Stapler Firing Failed complaints2016-07-14 · recall
• Zimmer Biomet recalls ROSA Brain 3.0 over insufficient washers allowing telescopic-arm movement2016-05-27 · recall
• Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command2016-04-08 · recall
• Zimmer Biomet recalls ROSA Herga Foot Switch over system freeze or shutdown in Fulgurate mode2016-01-20 · recall
• Intuitive recalls da Vinci 30-degree 8mm Endoscope over risk of patient harm from monopolar energy2015-11-23 · recall
• Intuitive recalls da Vinci Fundus Grasper over jaws that can become stuck closed2015-08-08 · recall
• Zimmer Biomet ROSA 2.5.8 recalled over a force-feedback sensor failure that can stop the arm from halting2014-11-06 · recall
• Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over an undetected shift between navigation display and patient anatomy2014-02-14 · recall
• FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events2013-07-19 · regulatory_action
• da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns2013-05-08 · recall
• Intuitive recalls da Vinci 8mm Maryland Bipolar Forceps over a cautery plug insert that can dislodge2013-05-08 · recall
• Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over observed device instability2013-02-05 · recall