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.

101–125 of 257

  • ModerateFDA (Devices)·Z-2835-2018·2018-08-22

    Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Defect

    Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller due to improper calibration. The defect may cause dim images, color imbalance, or increased fogging.

    Product
    The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2380-2018·2018-07-18

    Intuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component

    Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue.

    Product
    da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2381-2018·2018-07-18

    Intuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component

    Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue during surgery.

    Product
    da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2341-2018·2018-07-11

    Intuitive Surgical Recalls da Vinci X Systems with Defective Arm Controller Boards

    Intuitive Surgical is recalling 35 da Vinci X Surgical Systems because defective Arm Controller Joint boards have a high rate of failure.

    Product
    da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0404-2018·2018-01-31

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler 45 Instruments

    Intuitive Surgical is recalling 60 da Vinci Xi EndoWrist Stapler 45 instruments due to a manufacturing variation that may prevent the release wrench from unclamping the device.

    Product
    daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2017·2017-07-05

    Intuitive Surgical Recalls da Vinci Xi Surgical Systems Due to Brake Screw Issue

    Intuitive Surgical is recalling 10 da Vinci Xi Surgical Systems because brake screws on the patient side carts may be under-torqued.

    Product
    da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2017·2017-04-19

    Intuitive Surgical Recalls da Vinci Xi Suction Irrigator Instruments

    Intuitive Surgical is recalling 90 da Vinci Xi Suction Irrigator instruments due to unexpected arm motion with specific software.

    Product
    da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1723-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Issues

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpreted instructions may cause tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Japanese SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1728-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Spanish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1716-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Czech SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Turkish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1718-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Finnish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1727-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Card Issues

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Swedish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1717-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Dutch SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1715-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpreted instructions may cause tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Danish SRK. General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1719-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Errors

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi French SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1724-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Italian SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1726-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpreted instructions may cause tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1714-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1722-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Greek SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1721-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi German SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1720-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Norwegian SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1725-2017·2017-04-12

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits

    Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.

    Product
    STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Korean SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0315-2017·2016-11-02

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Software Anomaly

    Intuitive Surgical is recalling 677 da Vinci Xi Surgical Systems due to a software anomaly that may cause unexpected movement.

    Product
    da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical E
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2675-2016·2016-09-07

    Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.

    Product
    STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection 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.