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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.
Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgica...
Surgical Devices·3,698 affected·Aug 8, 2015
High RiskFDA
Intuitive Surgical, Inc.
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tis...
Surgical Devices·2,436 affected·May 21, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover ...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of s...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgi...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a va...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of sur...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical...
Surgical Devices·167 affected·Mar 3, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgic...
Surgical Devices·167 affected·Mar 3, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Inst...
Surgical Devices·167 affected·Mar 3, 2015
High RiskFDA
Intuitive Surgical, Inc.
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive S...
Cardiac Devices·706 affected·Feb 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sea...
Surgical Devices·3,282 affected·Feb 11, 2015
High RiskFDA
Intuitive Surgical, Inc.
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. In...
Surgical Devices·12,467 affected·Jan 21, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intui...
Surgical Devices·1,034 affected·Jan 15, 2015
High RiskFDA
Intuitive Surgical, Inc.
IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS...
Surgical Devices·202 affected·Dec 5, 2014
High RiskFDA
Intuitive Surgical, Inc.
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The In...
Surgical Devices·1,532 affected·Nov 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The In...
Surgical Devices·1,532 affected·Nov 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Cardiac Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·5 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si Syste...
Cardiac Devices·1,034 affected·Sep 18, 2014
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bip...
Surgical Devices·1,483 affected·Sep 17, 2014
High RiskFDA
Intuitive Surgical, Inc.
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instru...
Cardiac Devices·75 affected·Sep 11, 2014
High RiskFDA
Intuitive Surgical, Inc.
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Surgical Devices·19 affected·Jun 11, 2014
High RiskFDA
Intuitive Surgical, Inc.
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instr...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic I...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic In...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Inst...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical En...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is posi...
Surgical Devices·2 affected·May 9, 2014