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
December 3, 2014FDA8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Sur…Z-0443-2015
October 22, 2014FDAEndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS30…Z-0063-2015
October 22, 2014FDAEndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 …Z-0074-2015
October 8, 2014FDAASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product…Z-2731-2014
August 20, 2014FDAEndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 4…Z-2171-2014
July 16, 2014FDAPatient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. …Z-1994-2014
July 16, 2014FDAIntuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci …Z-2020-2014
July 9, 2014FDAVision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S Syst…Z-1966-2014
July 9, 2014FDAConnection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinc…Z-1974-2014
July 9, 2014FDAVessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da V…Z-1970-2014
July 9, 2014FDASystem Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci S…Z-1964-2014
July 9, 2014FDAVessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and…Z-1969-2014
July 9, 2014FDASingle Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical Sys…Z-1971-2014
July 9, 2014FDAEndowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da …Z-1965-2014
July 9, 2014FDAInsert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinc…Z-1967-2014
July 9, 2014FDAStapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vi…Z-1968-2014
July 9, 2014FDANatural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System a…Z-1975-2014
July 9, 2014FDAIRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si Sy…Z-1972-2014
July 9, 2014FDACautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci S…Z-1973-2014
July 2, 2014FDAIS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgi…Z-1871-2014
July 2, 2014FDAIS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgi…Z-1870-2014
June 11, 2014FDAPatient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgica…Z-1718-2014
April 16, 2014FDA5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3…Z-1332-2014
April 16, 2014FDA5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3…Z-1334-2014
April 16, 2014FDA5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3…Z-1333-2014

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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