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.

76–100 of 257

  • HighFDA (Devices)·Z-0489-2021·2020-12-02

    Intuitive Surgical Recalls ION Fully Articulating Catheters Due to Tip Ring Risk

    Intuitive Surgical is recalling 454 ION Fully Articulating Catheters because the distal tip ring may become dislodged during use.

    Product
    Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2021·2020-11-04

    Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Error

    Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller because improper calibration may cause the endoscope tip to reach higher temperatures, potentially leading to thermal tissue injury.

    Product
    da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform mi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2950-2020·2020-09-16

    Intuitive Surgical Recalls ION Reprocessing Accessories Kit Due to Catheter Failure Risk

    Intuitive Surgical is recalling 27 units of the ION Reprocessing Accessories Kit because the catheter reprocessing cover may disengage, causing chemical retention and system failure.

    Product
    ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2949-2020·2020-09-16

    Intuitive Surgical Recalls Ion Catheter Reprocessing Covers

    Intuitive Surgical is recalling 67 Ion Catheter Reprocessing Covers because they may fail to engage correctly, potentially causing catheter or system failure.

    Product
    Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2329-2020·2020-06-17

    Intuitive Surgical Recalls IS4000 Sterilization Trays Due to Sterility Breach Risk

    Intuitive Surgical is recalling IS4000 stainless steel reprocessing trays because small holes in the sterilization wrap could compromise sterility and increase infection risk.

    Product
    STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2020·2020-06-17

    Intuitive Surgical Recalls 8mm Endoscope Sterilization Trays Due to Sterility Risk

    Intuitive Surgical is recalling 1,757 stainless steel reprocessing trays because holes in the sterilization wrap could compromise sterility and increase infection risk.

    Product
    STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2020·2020-06-10

    Intuitive Recalls 17 da Vinci SP Surgical Systems Due to Software Anomaly

    Intuitive Surgical is recalling 17 da Vinci SP surgical systems because a software anomaly may cause mechanical vibration of instrument tips and the endoscope under rare conditions.

    Product
    da Vinci SP surgical system
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2131-2020·2020-06-03

    Intuitive Surgical Recalls da Vinci SP Cameras Due to Residual Soil

    Intuitive Surgical is recalling 305 da Vinci SP cameras because residual soil on the tip may affect image quality or cause patient sensitization.

    Product
    da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1960-2020·2020-05-20

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Arm Faults

    Intuitive Surgical is recalling 74 da Vinci Xi Surgical Systems because a manufacturing variation can cause arm faults and loss of functionality during surgery.

    Product
    da Vinci Xi Surgical System
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1961-2020·2020-05-20

    Intuitive Surgical Recalls da Vinci X Systems Due to Arm Fault

    Intuitive Surgical is recalling 74 da Vinci X Surgical Systems because a manufacturing variation in the arm can cause a fault error and loss of functionality during surgery.

    Product
    da Vinci X Surgical System
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1896-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci Xi Universal Surgical Manipulators

    Intuitive Surgical is recalling 270 Universal Surgical Manipulator units from da Vinci Xi systems due to high friction causing arm movement issues.

    Product
    da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its prim
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci SP Instrument Arm Drapes

    Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because they may tear, compromising the sterile barrier.

    Product
    da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1891-2020·2020-05-13

    Intuitive Surgical Recalls daVinci XI Sureform 60 Reloads Due to Staple Deployment Issues

    Intuitive Surgical is recalling specific daVinci XI Sureform 60 Reloads because a manufacturing variation may prevent adjacent staples from deploying, potentially causing an incomplete staple line.

    Product
    daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2020·2020-05-13

    Intuitive Surgical Recalls daVinci XI Sureform Stapler Reloads Due to Deployment Defect

    Intuitive Surgical is recalling 22,752 daVinci XI Sureform 60 reloads worldwide because a manufacturing variation may prevent adjacent staples from deploying, potentially causing an incomplete staple line.

    Product
    daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci X Universal Surgical Manipulators

    Intuitive Surgical is recalling 270 Universal Surgical Manipulators for da Vinci X systems due to high friction causing arm movement issues.

    Product
    da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its prima
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0926-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci Systems Due to Defective Capacitors

    Intuitive Surgical is recalling 52 da Vinci X surgical systems worldwide due to defective capacitors that may cause vision loss or system errors.

    Product
    da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0927-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci SP Systems Due to Defective Capacitors

    Intuitive Surgical is recalling four da Vinci SP Surgical Systems because defective capacitors on circuit boards may cause vision loss or non-recoverable system errors.

    Product
    da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Defective Capacitors

    Intuitive Surgical is recalling 123 da Vinci Xi surgical systems worldwide due to potentially defective capacitors that may cause vision loss or system errors.

    Product
    da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1105-2020·2020-02-12

    Intuitive Surgical Recalls Da Vinci Xi EndoWrist Monopolar Curved Scissors

    Intuitive Surgical is recalling 286 Da Vinci Xi EndoWrist Monopolar Curved Scissors because they are not recognized by the integrated electrosurgical unit, preventing the activation of monopolar energy.

    Product
    Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
    Category
    Medical Device
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-0845-2020·2020-02-05

    Intuitive da Vinci SP Surgical System Cannula Mount Button Recall

    Intuitive Surgical is recalling five da Vinci SP surgical systems because the cannula mount button may be damaged if released abruptly.

    Product
    The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (c
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0249-2020·2019-11-06

    Intuitive Surgical Recalls EndoWrist Suction Irrigator Due to Silicone Particle Risk

    Intuitive Surgical is recalling EndoWrist Suction Irrigator instruments because silicone particles may form and be introduced into patients during irrigation.

    Product
    EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3254-2018·2018-10-03

    Intuitive Surgical Recalls da Vinci Redundant Medical Grade Power Supply Units

    Intuitive Surgical is recalling specific da Vinci Surgical System power supply units that were manufactured incorrectly and may fail during use.

    Product
    da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasiv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3024-2018·2018-09-19

    Intuitive Surgical Recalls da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors

    Intuitive Surgical is recalling 23,064 da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors because cracks in the extension tube may cause plastic fragments to fall into patients.

    Product
    da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3025-2018·2018-09-19

    Intuitive Surgical Recalls da Vinci EndoWrist Scissors Due to Cracking Risk

    Intuitive Surgical is recalling 42,274 da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors because cracks may form in the extension tube, potentially causing fragments to fall into patients.

    Product
    da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and
    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.