Intuitive Surgical, Inc.: 134 recalls on record

Recalls filed with 1 agency: FDA (134).

First recall on record: August 8, 2012. Most recent: July 22, 2026.

Risk classification: Class I: 1 · Class II: 132 · Class III: 1

Most recent recalls

DateAgencyProduct
June 10, 2020FDAda Vinci SP surgical systemZ-2260-2020
May 20, 2020FDAda Vinci Xi Surgical SystemZ-1960-2020
May 13, 2020FDAdaVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 008868741…Z-1891-2020
February 12, 2020FDAda Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used w…Z-0926-2020
February 12, 2020FDAda Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscop…Z-0927-2020
February 12, 2020FDAda Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used…Z-0925-2020
July 11, 2018FDAda Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endos…Z-2341-2018
July 5, 2017FDAda Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) i…Z-2630-2017
April 19, 2017FDAda Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, …Z-1819-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1725-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1718-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1723-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1726-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1728-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1715-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1714-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1724-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1722-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1720-2017
April 12, 2017FDASTAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Z-1727-2017
November 2, 2016FDAda Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General …Z-0315-2017
September 7, 2016FDASTAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgi…Z-2675-2016
August 17, 2016FDASTAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgic…Z-2348-2016
January 20, 2016FDA30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. Genera…Z-0653-2016
September 16, 2015FDACadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 4280…Z-2752-2015

Questions about this company

How many recalls does Intuitive Surgical, Inc. have?
Recalert has 134 U.S. recalls on record for Intuitive Surgical, Inc., published between August 8, 2012 and July 22, 2026.
Which agencies have handled Intuitive Surgical, Inc. recalls?
Intuitive Surgical, Inc. appears as the recalling firm in recalls from: FDA (134).

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