The Recall Desk

Manufacturer

Intuitive Surgical, Inc.

72 recalls in our database name Intuitive Surgical, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 72

  • SevereFDA (Devices)·Z-1855-2026·2026-05-13

    Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect

    Intuitive Surgical is recalling Intuitive 8 mm SureForm 30 Gray Reloads (Reference Numbers 48230M-05 and 48230M-06) because they may produce an incomplete staple line during curved-tipped stapler operations.

    Product
    Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2046-2026·2026-05-13

    da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage

    Intuitive Surgical is recalling certain Universal Surgical Manipulator arm sub-assemblies in da Vinci X and Xi Surgical Systems due to screws that may be susceptible to breaking during use.

    Product
    Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1697-2026·2026-04-08

    da Vinci Grasper Instruments Recalled for Broken or Frayed Grip Cables

    Intuitive Surgical is recalling da Vinci S and Si Double Fenestrated Grasper Instruments due to increased complaints of broken or frayed grip cables.

    Product
    Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including bl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2026·2026-04-08

    da Vinci Surgical Forceps Instrument Recalled Due to Frayed or Broken Cables

    Intuitive Surgical is recalling 2,095 da Vinci S and Si Tenaculum Forceps Instruments due to increased complaints of frayed or broken pitch cables that could impair instrument function during surgery.

    Product
    Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp end
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2026·2026-04-08

    da Vinci S and Si Mega Needle Driver Instruments Recalled for Broken Grip Cables

    Intuitive Surgical is recalling da Vinci S and Si Mega Needle Driver Instruments due to broken or frayed grip cables. The defect could impair surgeon control during surgical procedures.

    Product
    Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp en
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2026·2026-04-08

    da Vinci S and Si Grasping Retractor Grip Cables May Break

    Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor surgical instruments due to increased reports of broken or frayed grip cables. Approximately 2,660 affected units have been distributed worldwide.

    Product
    Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp en
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2026·2026-04-08

    da Vinci Surgical Scissors Recalled Due to Frayed Grip Cables

    Intuitive Surgical is recalling da Vinci S and Si Monopolar Curved Scissors instruments due to increased reports of broken or frayed grip cables. These reusable surgical instruments transmit motion through cables that could malfunction during endoscopic procedures.

    Product
    Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2026·2026-04-08

    da Vinci Surgical Instruments Recalled for Frayed or Broken Cables

    Intuitive Surgical is recalling 6,152 da Vinci S and Si permanent cautery hook instruments due to complaints of frayed or broken pitch cables that could cause instrument malfunction during surgery.

    Product
    Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2026·2026-02-25

    Da Vinci 5 Surgical System Software Error Causes Monitor Display Loss

    Intuitive Surgical is recalling 12 Da Vinci 5 surgical systems due to a software error that can cause loss of user interface content on external monitors, potentially impairing surgeon visualization during minimally invasive procedures.

    Product
    Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1355-2026·2026-02-18

    da Vinci 5 Surgeon Console Viewer Display Firmware Defect Causes Visualization Loss

    A firmware defect in the da Vinci 5 Surgeon Console Viewer Display may cause loss of one or both displays during surgery. When visualization is lost, surgical instruments remain active, risking tissue injury and bleeding.

    Product
    da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2026·2026-02-11

    Robotic surgical systems recalled for undetected arm defects

    Intuitive Surgical recalled da Vinci X, Xi, and 5 surgical systems due to a software error that failed to detect bent manipulator arms. The faulty arms pose a risk of failure during surgery.

    Product
    Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components:
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1134-2026·2026-01-28

    Ion Vision Probe Bag Recalled for Compromised Sterile Seals

    Intuitive Surgical recalls 110,580 Ion Vision Probe Bags that may have compromised or incomplete sterile seals. Non-sterile devices used in surgical procedures could pose an infection risk.

    Product
    Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1096-2026·2026-01-21

    da Vinci SP Access Port Kit System Tray Cracks Risk Sterility Breach

    Intuitive Surgical is recalling da Vinci SP Access Port Kits because the system tray may develop cracks that could breach sterility during surgical use.

    Product
    da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2026·2025-12-31

    Surgical Robot Console Motor Connector Failure May Lock Ergonomic Controls

    Intuitive Surgical is recalling 144 da Vinci 5 Surgeon Console Column Motor Connectors due to potential connector failure that may lock ergonomic controls, preventing adjustment of headrest, armrest, viewer, and pedal tray until the device is restarted.

    Product
    da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2025·2025-03-19

    Da Vinci 5 surgical console foot pedals recalled for spring failure

    Intuitive Surgical has recalled 439 Da Vinci 5 surgical console foot tray pedals due to spring failures that can cause pedals to remain pressed and interfere with normal surgical robot operation.

    Product
    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2025·2025-01-22

    Intuitive Surgical Fenestrated Grasper Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling its 8MM Tip-Up Fenestrated Grasper due to frayed or broken grip cables on reusable surgical instruments. The defect affects multiple batch numbers produced between 2023 and 2024.

    Product
    8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0855-2025·2025-01-22

    Intuitive Surgical Recalls 8MM Micro Bipolar Forceps Due to Frayed Grip Cables

    Intuitive Surgical is recalling 178 units of its 8MM Micro Bipolar Forceps (Model 470171) due to increased complaints of frayed or broken grip cables on the reusable instruments. Affected devices have been distributed nationwide and internationally.

    Product
    8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0924-2025·2025-01-22

    FDA Recalls Small Graptor Retractor Instruments Due to Cable Failures

    Intuitive Surgical is recalling 42,028 Small Graptor surgical retractor instruments used with da Vinci X/Xi systems due to pitch cable failures. The recalled devices affect surgical facilities nationwide and internationally.

    Product
    8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0865-2025·2025-01-22

    Reusable Surgical Instruments Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling reusable surgical instruments due to reports of frayed or broken grip cables that may affect safe operation during procedures.

    Product
    8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0862-2025·2025-01-22

    Surgical Retractor Grip Cables May Fray or Break During Use

    Intuitive Surgical is recalling 738 units of the 8MM Atrial Retractor (Model 470246) due to reports of frayed or broken grip cables on reusable instruments. The defect could compromise instrument performance during surgical procedures.

    Product
    8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0850-2025·2025-01-22

    Intuitive Surgical Recalls 8MM Surgical Scissors for Grip Cable Defects

    Intuitive Surgical is recalling 4,259 units of 8MM round tip scissors due to complaints of frayed or broken grip cables. The defect could affect instrument reliability during surgical procedures.

    Product
    8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0881-2025·2025-01-22

    Intuitive Surgical Bipolar Dissector Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 8MM curved bipolar dissectors due to frayed or broken grip cables that could affect surgical instrument performance. Approximately 3,869 units were distributed nationwide and internationally.

    Product
    8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
    Category
    Medical Device
    Distribution
    0 states