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Intuitive Surgical, Inc. Recalls

168 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Intuitive Surgical, Inc..

168Total Recalls
3Critical
5.3MUnits Affected
Apr 2, 2026Most Recent
All Recalls

Every Intuitive Surgical, Inc. Recall

Sorted by most recent. Click any recall for full details.

168 recalls
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Medical Devices·305 affected·Aug 19, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and acce...
Surgical Devices·52 affected·Jul 26, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and ac...
Surgical Devices·123 affected·Jul 26, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perf...
Surgical Devices·4 affected·Jul 26, 2019
High RiskFDA
Intuitive Surgical, Inc.
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are i...
Surgical Devices·0 affected·Jul 1, 2019
High RiskFDA
Intuitive Surgical, Inc.
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are ...
Surgical Devices·22,752 affected·Jul 1, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision ...
Surgical Devices·1 affected·Jun 17, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP surgical system
Surgical Devices·17 affected·Apr 1, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System
Surgical Devices·74 affected·Nov 21, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System
Surgical Devices·74 affected·Nov 21, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Medical Devices·1,818 affected·Oct 25, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, s...
Cardiac Devices·23,064 affected·Aug 15, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console...
Surgical Devices·1,014 affected·Jul 16, 2018
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in en...
Surgical Devices·3,108 affected·Jun 4, 2018
CriticalFDA
Intuitive Surgical, Inc.
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Surgical Devices·1 affected·May 17, 2018
CriticalFDA
Intuitive Surgical, Inc.
da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
Medical Devices·6,816 affected·Apr 23, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surg...
Cardiac Devices·108 affected·Mar 7, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate c...
Surgical Devices·10 affected·Jun 1, 2017
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440...
Surgical Devices·15 affected·Mar 31, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. General and Plastic...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Danish SRK. General and Plastic S...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Spanish SRK General and Plastic Sur...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese SRK General and Plastic ...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Finnish SRK General and Plastic S...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Greek SRK General and Plastic Sur...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Swedish SRK General and Plastic Surge...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Korean SRK General and Plastic Su...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Italian SRK General and Plastic S...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Norwegian SRK General and Plastic...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Japanese SRK General and Plastic ...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical End...
Surgical Devices·677 affected·Oct 5, 2016
High RiskFDA
Intuitive Surgical, Inc.
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Re...
Surgical Devices·2,065 affected·Jul 14, 2016
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Re...
Surgical Devices·875 affected·Jul 14, 2016
High RiskFDA
Intuitive Surgical, Inc.
STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument ...
Surgical Devices·875 affected·Jul 14, 2016
High RiskFDA
Intuitive Surgical, Inc.
SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical S...
Surgical Devices·46,191 affected·May 9, 2016
High RiskFDA
Intuitive Surgical, Inc.
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Sur...
Surgical Devices·46 affected·May 9, 2016
CriticalFDA
Intuitive Surgical, Inc.
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intu...
Surgical Devices·43 affected·Mar 25, 2016
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control S...
Cardiac Devices·248 affected·Mar 16, 2016
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accur...
Cardiac Devices·542 affected·Feb 16, 2016
High RiskFDA
Intuitive Surgical, Inc.
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscop...
Medical Devices·2,624 affected·Nov 23, 2015
High RiskFDA
Intuitive Surgical, Inc.
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope...
Medical Devices·2,624 affected·Nov 23, 2015
High RiskFDA
Intuitive Surgical, Inc.
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. ...
Surgical Devices·1,200 affected·Sep 9, 2015
High RiskFDA
Intuitive Surgical, Inc.
Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da V...
Surgical Devices·6,309 affected·Aug 8, 2015
High RiskFDA
Intuitive Surgical, Inc.
Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive S...
Surgical Devices·17,617 affected·Aug 8, 2015
High RiskFDA
Intuitive Surgical, Inc.
Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intuitive Surgical da ...
Surgical Devices·2,410 affected·Aug 8, 2015
High RiskFDA
Intuitive Surgical, Inc.
Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive ...
Surgical Devices·21,684 affected·Aug 8, 2015
High RiskFDA
Intuitive Surgical, Inc.
Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuit...
Surgical Devices·8,217 affected·Aug 8, 2015
High RiskFDA
Intuitive Surgical, Inc.
Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vi...
Surgical Devices·89 affected·Aug 8, 2015