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.

151–175 of 257

  • HighFDA (Devices)·Z-1812-2015·2015-06-24

    Intuitive Surgical Recalls 5 mm Thoracic Grasper Due to Coating Damage

    Intuitive Surgical is recalling 2,436 units of 5 mm Thoracic Graspers because coating damage could cause fragments to fall into patients.

    Product
    Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1386-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Monitor Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci Si Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1392-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1385-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Camera Head Drapes

    Intuitive Surgical is recalling da Vinci Si Camera Head Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1381-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Camera Arm Drapes

    Intuitive Surgical is recalling da Vinci S Camera Arm Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1390-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1384-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Monitor Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Vision-Cart Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1393-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1380-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Arm Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Surgical System arm drapes due to a cloudy, waxy appearance that may transfer to patients or cause tearing.

    Product
    da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1389-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a potential for the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1382-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Camera Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Camera Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1391-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Camera Arm Drapes

    Intuitive Surgical is recalling da Vinci Si Camera Arm Drapes due to a cloudy appearance and potential to tear or transfer waxy substance to patients.

    Product
    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1388-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Camera Arm Drapes for Defects

    Intuitive Surgical is recalling da Vinci S/Si Camera Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1387-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Instrument Arm Drapes Due to Defects

    Intuitive Surgical is recalling da Vinci S/Si Instrument Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1383-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Patient-Cart Monitor Drapes

    Intuitive Surgical is recalling da Vinci S Patient-Cart Monitor Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1304-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal SUJ failures and position sensor mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide because a fault causes distal SUJ failures and position sensor mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Joint Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal sensor failures and position mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2015·2015-03-11

    Intuitive Surgical Recalls Vacuum Source Tubing Sets for Sterility Concerns

    Intuitive Surgical is recalling 706 Vacuum Source Tubing Sets for the EndoWrist Stabilizer because shipping damage may have compromised the sterile packaging.

    Product
    Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical En
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1141-2015·2015-03-04

    Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference

    Intuitive Surgical is recalling 3,282 EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.

    Product
    EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1142-2015·2015-03-04

    Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference

    Intuitive Surgical is recalling EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.

    Product
    EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1117-2015·2015-02-25

    Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use

    Intuitive Surgical is recalling Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.

    Product
    HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1118-2015·2015-02-25

    Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use

    Intuitive Surgical is recalling 12,467 Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.

    Product
    HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1048-2015·2015-02-11

    Intuitive Surgical Recalls da Vinci Si Wall Charts for Sterilization Inconsistency

    Intuitive Surgical is recalling 1,034 da Vinci Si Wall Charts because they contained incorrect sterilization dry time information inconsistent with the User Manual.

    Product
    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2015·2015-01-14

    Intuitive Surgical Recalls da Vinci Si Vision Side Carts Due to Wheel Loosening

    Intuitive Surgical is voluntarily correcting 202 da Vinci Si Vision Side Carts where caster wheel bolts may unthread, causing wheels to loosen.

    Product
    IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to a
    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.