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.

226–250 of 257

  • HighFDA (Devices)·Z-0521-2014·2013-12-25

    Intuitive Surgical Recalls Large Needle Drivers Due to Jaw Insert Detachment Risk

    Intuitive Surgical is recalling Large Needle Drivers for the da Vinci S and Si systems because the jaw insert may detach during use.

    Product
    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2014·2013-12-11

    Intuitive Surgical Recalls da Vinci Patient Side Manipulator Assemblies

    Intuitive Surgical is recalling 1,386 da Vinci Patient Side Manipulator assemblies due to friction that can cause instrument motion to stall and catch up.

    Product
    Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2014·2013-11-13

    Intuitive Surgical Recalls da Vinci Patient Carts Due to Fluid Complaints

    Intuitive Surgical is recalling 1,754 da Vinci S and SI Patient Carts worldwide due to increased complaints about fluid entering the cart base.

    Product
    Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0146-2014·2013-11-13

    Intuitive Surgical Recalls da Vinci Vision System Cart Components

    Intuitive Surgical is recalling da Vinci Vision System Cart components due to a coating incompatibility that triggers erroneous maintenance alerts.

    Product
    da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Visio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2014·2013-11-06

    Intuitive Surgical Recalls da Vinci Si Surgical Systems Due to Mounting Risk

    Intuitive Surgical is recalling 1,090 da Vinci Si Surgical Systems because improper restraints during transport could cause the monitor to become loose from its mount.

    Product
    da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0111-2014·2013-11-06

    Intuitive Surgical da Vinci Single Site Instruments Recalled for Missing Manual Revisions

    Intuitive Surgical is recalling specific da Vinci Single Site instruments because they were shipped without the correct user manual revision, which contains necessary instructions, warnings, and precautions.

    Product
    Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2014·2013-11-06

    Intuitive Surgical Recalls da Vinci Single Site Instruments for Missing Manual Revisions

    Intuitive Surgical is recalling da Vinci Single Site Bipolar Maryland Forceps and curved needle drivers shipped with incorrect user manuals.

    Product
    Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Dual Camera Controllers for Testing Compliance

    Intuitive Surgical is recalling 30 da Vinci Dual Camera Controllers because factory testing may not have complied with UL standards due to a malfunctioning test device.

    Product
    da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1689-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Instrument Control Boxes

    Intuitive Surgical is recalling 30 da Vinci Instrument Control Boxes because factory testing may not have met UL standards due to a malfunctioning test device.

    Product
    da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1686-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Si Surgeon Side Carts for Testing Compliance

    Intuitive Surgical is recalling 30 da Vinci Si Surgeon Side Carts because factory testing may not comply with UL standards due to a malfunctioning test device.

    Product
    da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended fo
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1687-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Si Vision System Carts

    Intuitive Surgical is recalling 30 da Vinci Si Vision System Carts because factory testing may not have complied with UL standards due to a malfunctioning test device.

    Product
    da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended f
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1442-2013·2013-06-12

    Intuitive Surgical Recalls Monopolar Curved Scissors Due to Thermal Injury Risk

    Intuitive Surgical is recalling approximately 132,441 EndoWrist Monopolar Curved Scissors instruments worldwide. The recall addresses potential cracks that may cause electrosurgical energy leaks and thermal injury to tissue.

    Product
    8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1464-2013·2013-06-12

    Intuitive Surgical Recalls da Vinci 5 mm Flared Instrument Cannulae

    Intuitive Surgical is voluntarily recalling da Vinci 5 mm Flared Instrument Cannulae to implement a modified inspection process.

    Product
    da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1463-2013·2013-06-12

    Intuitive Surgical Recalls da Vinci 5 mm Instrument Cannulae for Inspection Changes

    Intuitive Surgical is voluntarily modifying the inspection process for da Vinci 5 mm Instrument Cannulae used in surgical systems.

    Product
    da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1433-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Cautery Plug Defect

    Intuitive Surgical is recalling 8mm Fenestrated Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.

    Product
    8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Precise Bipolar Forceps Due to Cautery Plug Defect

    Intuitive Surgical is recalling 8mm Precise Bipolar Forceps used with the da Vinci Surgical System because a component may dislodge, preventing proper cautery connection and causing loss of function.

    Product
    8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Cautery Plug Defect

    Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.

    Product
    8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2013·2013-06-05

    Intuitive Surgical Recalls Tip Cover Accessories for Labeling Clarification

    Intuitive Surgical is recalling 50,000 boxes of Tip Cover Accessories for the da Vinci Surgical System to clarify existing labeling and related cautions.

    Product
    Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1427-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Cannulas for Labeling Clarification

    Intuitive Surgical is recalling 8mm cannulas to clarify existing labeling information and operating procedures.

    Product
    Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1428-2013·2013-06-05

    Intuitive Surgical Recalls da Vinci Flush Ports for Labeling Clarification

    Intuitive Surgical is recalling da Vinci instrument flush ports to clarify existing labeling and operating procedures.

    Product
    Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1424-2013·2013-06-05

    Intuitive Surgical Recalls da Vinci TORS User Manual Addendum

    Intuitive Surgical is recalling 1,374 user manual addenda for the da Vinci Surgical System to remove an indication and amend warnings for Transoral Surgery.

    Product
    User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings f
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1429-2013·2013-06-05

    Intuitive Surgical da Vinci Si Surgeon Console Labeling Clarification

    Intuitive Surgical is clarifying labeling and operating procedures for the da Vinci Si Surgeon Console to ensure accurate control of endoscopic instruments.

    Product
    da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1426-2013·2013-06-05

    Intuitive Surgical Recalls Unapproved da Vinci Thyroidectomy Promotional Literature

    Intuitive Surgical is recalling promotional literature for the da Vinci Surgical System's thyroidectomy indication because the use was not approved with a 510(k) change.

    Product
    Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (op
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1110-2013·2013-04-24

    Intuitive Surgical da Vinci System User Manual Recall for Sterile Adapter Instructions

    Intuitive Surgical is recalling IS3000 user manuals for da Vinci Si and Si-e systems to provide revised instructions for sterile adapter engagement and instrument installation.

    Product
    IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2013·2013-04-24

    Intuitive Surgical Recalls da Vinci S User Manual for Sterile Adapter Instructions

    Intuitive Surgical is recalling IS2000 user manuals for the da Vinci S system to provide revised instructions on sterile adapter engagement and instrument installation.

    Product
    IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.