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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.
April 12, 2017Medical DevicesFDA
Intuitive Surgical, Inc. recalls STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Czech SRK Genera
Hazard: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
April 12, 2017Medical DevicesFDA
Intuitive Surgical, Inc. recalls STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Danish SRK. Gene
Hazard: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
April 12, 2017Medical DevicesFDA
Intuitive Surgical, Inc. recalls STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. Ge
Hazard: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
November 2, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intui
Hazard: Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances
September 7, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci Endo
Hazard: Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
September 7, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapl
Hazard: Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
September 7, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler
Hazard: Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
August 17, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWri
Hazard: An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
August 17, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler
Hazard: An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
August 17, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler
Hazard: An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
June 8, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vi
Hazard: Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
June 8, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. Th
Hazard: Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
May 4, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General
Hazard: Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
April 20, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Ins
Hazard: Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.
April 20, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive
Hazard: Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.
March 30, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to as
Hazard: FDA Class II
January 20, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da
Hazard: This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.
January 20, 2016Medical DevicesFDA
Intuitive Surgical, Inc. recalls 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da V
Hazard: This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.
September 23, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156
Hazard: B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.
September 16, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13.
Hazard: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
September 16, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The
Hazard: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
September 16, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05.
Hazard: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
September 16, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Int
Hazard: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
September 16, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuit
Hazard: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
September 16, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuiti
Hazard: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
September 16, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intui
Hazard: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
September 16, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15.
Hazard: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
September 16, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-
Hazard: In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
September 9, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Int
Hazard: Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
July 8, 2015Medical DevicesFDA
Intuitive Surgical, Inc. recalls INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Inst
Hazard: Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error.