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.

176–200 of 257

  • ModerateFDA (Devices)·Z-0835-2015·2014-12-31

    Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info

    Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.

    Product
    Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0834-2015·2014-12-31

    Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info

    Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.

    Product
    Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Potts Scissors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 8mm Potts Scissors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0429-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Black Diamond Micro Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Black Diamond Micro Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0428-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Large Needle Driver Instruments

    Intuitive Surgical is recalling 509 8mm Large Needle Driver instruments due to potential surface degradation and accelerated mechanical wear caused by reprocessing deviations.

    Product
    8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0443-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Dual Blade Retractors for Reprocessing Issues

    Intuitive Surgical is recalling 509 units of 8mm Dual Blade Retractors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0434-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Monopolar Curved Scissors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Monopolar Curved Scissors because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0441-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Large Hem-O-Lok Clip Applier Devices

    Intuitive Surgical is voluntarily recalling 509 units of 8mm Large Hem-O-Lok Clip Appliers due to a Class II device defect. The affected instruments were distributed to facilities in eight US states.

    Product
    8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0446-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Clip Appliers Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm clip appliers because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0447-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Curved Bipolar Dissectors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Curved Bipolar Dissectors because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0442-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Atrial Retractor Instruments Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Atrial Retractor Short Right instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0432-2015·2014-12-03

    Intuitive Surgical Recalls 8mm ProGrasp Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 8mm ProGrasp Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0440-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Cardiac Probe Grasper Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Cardiac Probe Graspers because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0439-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Tenaculum Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Tenaculum Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0444-2015·2014-12-03

    Intuitive Surgical Recalls 8mm MEGA SUTURECUT ND Instruments

    Intuitive Surgical is recalling 509 units of 8mm MEGA SUTURECUT ND instruments due to potential surface degradation and accelerated mechanical wear.

    Product
    8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0435-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Resano Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 8mm Resano Forceps instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0431-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Micro Bipolar Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Micro Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0436-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Permanent Cautery Hooks Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 8mm Permanent Cautery Hooks because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0430-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Long Tip Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Long Tip Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0448-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Tip-Up Fenestrated Graspers for Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Tip-Up Fenestrated Graspers because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0445-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Small Grasping Retractor for Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of the 8mm Small Grasping Retractor because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0433-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0437-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Permanent Cautery Spatulas for Housing Degradation

    Intuitive Surgical is recalling 509 units of 8mm Permanent Cautery Spatulas because deviations in reprocessing steps can cause surface degradation of the housing and accelerate mechanical wear.

    Product
    8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0438-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Fenestrated Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0074-2015·2014-10-22

    Intuitive Surgical Recalls EndoWrist Stapler 45 Instruments

    Intuitive Surgical is recalling 1,034 EndoWrist Stapler 45 instruments because they may not be removable from tissue.

    Product
    EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic I
    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.