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Intuitive Surgical Recalls
257 recalls on record · August 8, 2012 to July 22, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 24, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic ma
Hazard: The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to co
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to c
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be us
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be u
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cov
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 15, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a v
Hazard: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
April 1, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgic
Hazard: Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
April 1, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The I
Hazard: Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
April 1, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The
Hazard: Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
March 11, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05.
Hazard: There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
March 4, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The
Hazard: Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.
March 4, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWri
Hazard: Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.
February 25, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000
Hazard: Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
February 25, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Int
Hazard: Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
February 11, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate
Hazard: The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.
January 14, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05
Hazard: Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.
December 31, 2014Medical DevicesFDA
Intuitive Surgical, Inc. recalls Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgica
Hazard: The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.
December 31, 2014Medical DevicesFDA
Intuitive Surgical, Inc. recalls Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgica
Hazard: The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.
December 3, 2014Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instrume
Hazard: Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
December 3, 2014Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instrument
Hazard: Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
December 3, 2014Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instrumen
Hazard: Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.