The Recall Desk

Manufacturer

Intuitive Surgical, Inc.

75 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 75

  • 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
  • Severity pendingFDA (Devices)·Z-2310-2026·2026-06-10

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software

    Pending LLM rewrite. Source: FDA_DEVICE Z-2310-2026.

    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
    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
  • Severity pendingFDA (Devices)·Z-1696-2026·2026-04-08

    Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Mon

    Pending LLM rewrite. Source: FDA_DEVICE Z-1696-2026.

    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
  • Severity pendingFDA (Devices)·Z-1697-2026·2026-04-08

    Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Doubl

    Pending LLM rewrite. Source: FDA_DEVICE Z-1697-2026.

    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
  • Severity pendingFDA (Devices)·Z-1699-2026·2026-04-08

    Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retr

    Pending LLM rewrite. Source: FDA_DEVICE Z-1699-2026.

    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
  • Severity pendingFDA (Devices)·Z-1698-2026·2026-04-08

    Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle D

    Pending LLM rewrite. Source: FDA_DEVICE Z-1698-2026.

    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
  • Severity pendingFDA (Devices)·Z-1701-2026·2026-04-08

    Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent

    Pending LLM rewrite. Source: FDA_DEVICE Z-1701-2026.

    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
  • Severity pendingFDA (Devices)·Z-1700-2026·2026-04-08

    Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forc

    Pending LLM rewrite. Source: FDA_DEVICE Z-1700-2026.

    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
  • Severity pendingFDA (Devices)·Z-1232-2026·2026-02-11

    Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System M

    Pending LLM rewrite. Source: FDA_DEVICE Z-1232-2026.

    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
  • Severity pendingFDA (Devices)·Z-1134-2026·2026-01-28

    Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127

    Pending LLM rewrite. Source: FDA_DEVICE Z-1134-2026.

    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-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-0882-2025·2025-01-22

    Intuitive Surgical Bipolar Grasper Recall Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 14,507 8MM Long Bipolar Graspers due to increased complaints of frayed or broken grip cables that could impair surgical control during laparoscopic procedures.

    Product
    8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
    Category
    Medical Device
    Distribution
    0 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
    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-0859-2025·2025-01-22

    Intuitive Surgical Recalls Fenestrated Bipolar Forceps Over Frayed Grip Cables

    Intuitive Surgical recalls 8MM Fenestrated Bipolar Forceps due to increased complaints about frayed or broken grip cables on 12,340 units distributed nationwide and internationally.

    Product
    8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
    Category
    Medical Device
    Distribution
    0 states