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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 5, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electr
Hazard: Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
June 5, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electr
Hazard: Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
June 5, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Hazard: Clarification of existing labeling information and operating procedures.
June 5, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Hazard: Clarification of existing labeling information and operating procedures.
June 5, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human bo
Hazard: Clarification of existing labeling information and operating procedures.
June 5, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally
Hazard: Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
June 5, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction w
Hazard: Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
June 5, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manua
Hazard: Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
April 24, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000.
Hazard: Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
April 24, 2013Medical DevicesFDA
Intuitive Surgical, Inc. recalls IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from
Hazard: Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
September 19, 2012Medical DevicesFDA
Intuitive Surgical, Inc. recalls Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use o
Hazard: There is potential for the sterility of the product to be compromised.
August 8, 2012Medical DevicesFDA
Intuitive Surgical, Inc. recalls ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equ
Hazard: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
August 8, 2012Medical DevicesFDA
Intuitive Surgical, Inc. recalls KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to p
Hazard: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
August 8, 2012Medical DevicesFDA
Intuitive Surgical, Inc. recalls KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to pr
Hazard: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
August 8, 2012Medical DevicesFDA
Intuitive Surgical, Inc. recalls KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to pr
Hazard: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
August 8, 2012Medical DevicesFDA
Intuitive Surgical, Inc. recalls KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to pr
Hazard: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
August 8, 2012Medical DevicesFDA
Intuitive Surgical, Inc. recalls INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect e
Hazard: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.