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
April 16, 2014FDA5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3…Z-1335-2014
December 25, 2013FDAMega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. M…Z-0520-2014
December 25, 2013FDALarge Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. …Z-0521-2014
December 11, 2013FDAAssembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical Sys…Z-0436-2014
November 13, 2013FDAda Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y19…Z-0146-2014
November 13, 2013FDAPatient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive…Z-0139-2014
November 6, 2013FDASingle Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The I…Z-0110-2014
November 6, 2013FDAda Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a hig…Z-0088-2014
November 6, 2013FDASingle Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intui…Z-0111-2014
July 17, 2013FDAda Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgi…Z-1689-2013
July 17, 2013FDAda Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical…Z-1686-2013
July 17, 2013FDAda Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgic…Z-1688-2013
July 17, 2013FDAda Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgica…Z-1687-2013
June 12, 2013FDA8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: I…Z-1442-2013
June 12, 2013FDAda Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Syst…Z-1464-2013
June 12, 2013FDAda Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. …Z-1463-2013
June 5, 2013FDAUser Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. …Z-1424-2013
June 5, 2013FDAFlush Port (used in almost all da Vinci instruments) Assists in cleaning the instrumen…Z-1428-2013
June 5, 2013FDA8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, M…Z-1433-2013
June 5, 2013FDACannula 8MM Regular. Provides the means of introduction and placement of an instrument…Z-1427-2013
June 5, 2013FDA8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model…Z-1432-2013
June 5, 2013FDAThyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci T…Z-1426-2013
June 5, 2013FDA8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model…Z-1431-2013
June 5, 2013FDAda Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive S…Z-1429-2013
June 5, 2013FDATip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover acc…Z-1425-2013

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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