The Recall Desk

Manufacturer

Intuitive Surgical, Inc.

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

What the numbers show

Total
257
Critical
0
Severe
15
Most recent
2026-07-22

Of the 257 recalls from Intuitive Surgical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (6%) are Severe.

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 257

  • ModerateFDA (Devices)·Z-2722-2026·2026-07-22

    da Vinci SP Instrument Arm Drape may detach during surgical procedures

    Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because the drape rings may detach, exposing the instrument arm and potentially delaying procedures. The recall affects 11,113 units distributed worldwide.

    Product
    da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2521-2026·2026-07-01

    Da Vinci surgical system operative components with E-brake retainer pin defect

    Intuitive Surgical recalls certain Da Vinci surgical system operative components due to a defective E-brake retainer pin that may fail to engage the E-brake, potentially causing uncontrolled motion and patient injury.

    Product
    Da Vinci ASSY, PSS, SP1098, Part Number: 380601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2026·2026-06-10

    Da Vinci 5 tower may unintentionally activate the infrared handheld camera

    The Da Vinci 5 system tower is being corrected because the near infrared handheld camera can be unintentionally activated when a user tries to turn off illumination.

    Product
    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integ
    Category
    Medical Device
    Distribution
    49 states
  • 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
    49 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-1699-2026·2026-04-08

    da Vinci grasping retractor instruments recalled over broken grip cables

    Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    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-1697-2026·2026-04-08

    da Vinci double fenestrated grasper recalled over broken grip cables

    Intuitive Surgical is recalling da Vinci S and Si Double Fenestrated Grasper Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    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-1698-2026·2026-04-08

    da Vinci mega needle driver recalled over broken or frayed cables

    Intuitive Surgical is recalling da Vinci S and Si Mega Needle Driver Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    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-1701-2026·2026-04-08

    da Vinci permanent cautery hook recalled over frayed pitch cables

    Intuitive Surgical is recalling da Vinci S and Si Permanent Cautery Hook Instruments following increased complaints regarding frayed or broken pitch cables on reusable surgical instruments.

    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-1700-2026·2026-04-08

    da Vinci tenaculum forceps recalled over frayed or broken pitch cables

    Intuitive Surgical is recalling da Vinci S and Si Tenaculum Forceps Instruments following increased complaints regarding frayed or broken pitch cables on reusable surgical instruments.

    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-1696-2026·2026-04-08

    da Vinci monopolar curved scissors recalled over frayed grip cables

    Intuitive Surgical is recalling da Vinci S and Si Monopolar Curved Scissors Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    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-1428-2026·2026-02-25

    Da Vinci 5 Surgical System Console Recalled Due to Software Error

    Intuitive Surgical, Inc. is recalling the Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 due to a software error that can cause loss of user interface content on monitors.

    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

    Surgeon console displays recalled over firmware that can lose visualization

    Intuitive Surgical is recalling 47 da Vinci 5 Surgeon Console Viewer Displays manufactured with outdated firmware, which may cause loss of the 3D surgical field or complete visualization loss.

    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

    Surgical robots recalled over a software error hiding failed arm diagnostics

    Intuitive Surgical is recalling 219 da Vinci X, Xi and da Vinci 5 systems because a software error allowed instrument arms failing an important diagnostic test to remain in clinical use.

    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
  • ModerateFDA (Devices)·Z-1134-2026·2026-01-28

    iM series patient monitors recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 14,550 units of its Patient Monitor models iM50, iM60, iM70 and iM80 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    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

    Surgical access port kits recalled over trays that may crack

    Intuitive Surgical is recalling 41,526 da Vinci SP Access Port Kits because the Access Port System tray may develop cracks, potentially resulting in a sterility breach.

    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 motors recalled over an error that locks ergonomics

    Intuitive Surgical is recalling 144 da Vinci 5 Surgeon Console Column Motor Connectors because a connector fault triggers Error 23062 and locks console ergonomics until the motor is replaced.

    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-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
    52 states
  • HighFDA (Devices)·Z-0879-2025·2025-01-22

    Intuitive Surgical Needle Driver Recall Due to Grip Cable Failures

    Intuitive Surgical is recalling 8MM Large Suture Cut Needle Drivers (Model 471296) due to complaints of frayed or broken grip cables. Affected instruments may lose functionality during surgical use.

    Product
    8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0861-2025·2025-01-22

    HEM-O-LOK Clip Applier Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 29,559 units of the 8MM Large HEM-O-LOK Clip Applier for frayed or broken grip cables on the reusable surgical instrument jaws.

    Product
    8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0878-2025·2025-01-22

    Fenestrated Bipolar Forceps Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 147,006 units of 8MM Fenestrated Bipolar Forceps due to increased complaints of frayed or broken grip cables, which could impair surgical control.

    Product
    8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0870-2025·2025-01-22

    Intuitive Surgical Clip Applier Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 5,576 units of the 8MM Horizon Small Clip Applier due to complaints of frayed or broken grip cables on the reusable instruments.

    Product
    8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
    Category
    Medical Device
    Distribution
    52 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Intuitive Surgical

American corporation

Country
United States
Founded
1995

Official website

Source: Wikidata (Q2743863), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.