Intuitive Surgical, Inc.
257 recalls on record · Latest: Jul 22, 2026
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Agency notice ledger
Federal filing book Intuitive Surgical, Inc. HEAVY-BOOK · SINGLE-AGENCY
#49 of 14,151 · 257 notices · 0.246% archive
- BOOK 257 notices
- RANK #49 of 14,151
- SHARE 0.246% archive
- AGENCY FDA Devices (257)
- CAT medical devices
- CATS 1 category
- LATEST Jul 22, 2026
- PHOTO Hospira Inc.
Nearest notice-volume peer: Hospira Inc. (0 notice gap)
Intuitive Surgical, Inc. accounts for about 0.246% of the 104,423-notice archive on 257 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Intuitive Surgical, Inc.'s standing among 14,151 recalling firms
Intuitive Surgical, Inc. ranks 49th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Intuitive Surgical, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
257 49th of 14151 higher than 14,102 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Intuitive Surgical, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
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261 notices
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258 notices
- Intuitive Sur… (this)
Intuitive Surgical, Inc.
257 notices
- Hospira Inc.
Hospira Inc.
257 notices
- Biomet, Inc.
Biomet, Inc.
255 notices
What this shows Intuitive Surgical, Inc. holds about 0.246% of archive notices alongside 257 distinct filings.
FDA Devices Moderate Oct 22, 2014
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories fo
FDA Devices Moderate Oct 8, 2014
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissu
FDA Devices Moderate Aug 20, 2014
EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
FDA Devices Moderate Jul 16, 2014
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
FDA Devices Moderate Jul 16, 2014
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
FDA Devices Moderate Jul 9, 2014
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
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. Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 9, 2014
Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jul 2, 2014
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
FDA Devices Moderate Jul 2, 2014
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
FDA Devices Moderate Jun 11, 2014
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.
FDA Devices Moderate Apr 16, 2014
5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing
FDA Devices Moderate Apr 16, 2014
5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing
FDA Devices Moderate Apr 16, 2014
5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing
FDA Devices Moderate Apr 16, 2014
5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing
FDA Devices Moderate Dec 25, 2013
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family
FDA Devices Moderate Dec 25, 2013
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument famil
FDA Devices Moderate Dec 11, 2013
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors,
FDA Devices Low Nov 13, 2013
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for the surgeon (at the 3D viewer) and the patient-side assistant (at the touchscreen). The 3DHD endoscope assembly (endoscope and camera head) can be used manually (that is, han
FDA Devices Moderate Nov 13, 2013
Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables t
FDA Devices Moderate Nov 6, 2013
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
FDA Devices Moderate Nov 6, 2013
Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and
FDA Devices Moderate Nov 6, 2013
Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy
FDA Devices Moderate Jul 17, 2013
da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
FDA Devices Moderate Jul 17, 2013
da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
FDA Devices Moderate Jul 17, 2013
da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
FDA Devices Moderate Jul 17, 2013
da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
FDA Devices Moderate Jun 12, 2013
da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
FDA Devices Moderate Jun 12, 2013
da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
FDA Devices Moderate Jun 12, 2013
8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
FDA Devices Moderate Jun 5, 2013
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
FDA Devices Moderate Jun 5, 2013
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Jun 5, 2013
8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
FDA Devices Moderate Jun 5, 2013
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
FDA Devices Moderate Jun 5, 2013
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
FDA Devices Moderate Jun 5, 2013
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
FDA Devices Moderate Jun 5, 2013
8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
FDA Devices Moderate Jun 5, 2013
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
FDA Devices Moderate Jun 5, 2013
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
FDA Devices Moderate Apr 24, 2013
IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
FDA Devices Moderate Apr 24, 2013
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
Intuitive Surgical, Inc. carries an outsized archive share
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (257 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Intuitive Surgical, Inc.? ▼
PlainRecalls indexes 257 distinct federal recall events naming Intuitive Surgical, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Intuitive Surgical, Inc. sit among other recalling firms? ▼
Intuitive Surgical, Inc. ranks #49 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Intuitive Surgical, Inc.'s notices? ▼
FDA Devices accounts for 257 of this firm's 257 indexed notices.
What product category dominates Intuitive Surgical, Inc.'s filing book? ▼
Filings for Intuitive Surgical, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Intuitive Surgical, Inc.: 257 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Intuitive Surgical, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026