Manufacturer

Intuitive Surgical, Inc.

257 recalls in our database name Intuitive Surgical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 257
Critical: 0
Severe: 15
Most recent: 2026-07-22

Of the 257 recalls from Intuitive Surgical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (6%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

201–225 of 257

ModerateFDA (Devices)·Z-0063-2015·2014-10-22
Intuitive Surgical Recalls EndoWrist One Vessel Sealer for Labeling and Software Issues
Intuitive Surgical is voluntarily correcting labeling and software for the EndoWrist One Vessel Sealer used with the da Vinci Si Surgical System.
Product
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2731-2014·2014-10-08
Intuitive Surgical Recalls da Vinci Xi Patient Side Carts Due to Sensor Failure
Intuitive Surgical is recalling 75 da Vinci Xi Patient Side Carts because a motor sensor failure can occur after a mid-procedure restart.
Product
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 Ins
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2171-2014·2014-08-20
Intuitive Surgical Recalls EndoWrist Stapler Manuals for pH Specification Change
Intuitive Surgical is recalling EndoWrist Stapler 45 User Manual Addenda and Wall Charts to correct the pH range specification for enzymatic cleaners.
Product
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, Gyn
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1994-2014·2014-07-16
Intuitive Surgical Recalls Patient Side Cart Battery Boxes for Overheating Risk
Intuitive Surgical is recalling 2,606 Patient Side Cart Battery Boxes used with the da Vinci A surgical system because they may overheat and bulge during charging.
Product
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2020-2014·2014-07-16
Intuitive Surgical Recalls Large Clip Applier Instruments Due to Jamming Risk
Intuitive Surgical is recalling Large Clip Applier instruments used with da Vinci S and SI systems because a manufacturing defect may cause the instrument to jam during insertion.
Product
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
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1967-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Surgical System Instrument Release Kits
Intuitive Surgical is recalling Instrument Release Kits for the da Vinci Surgical System to remove the Emergency Grip Release Wrench.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1970-2014·2014-07-09
Intuitive Surgical Recalls Vessel Sealer QRG for da Vinci Systems
Intuitive Surgical is recalling Vessel Sealer QRGs for da Vinci systems to remove the Emergency Grip Release Wrench from documentation.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1968-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Stapler Addendum Documentation
Intuitive Surgical is recalling documentation for the da Vinci Surgical System stapler addendum to remove references to the Emergency Grip Release Wrench.
Product
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1965-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Endowrist Instrument Manuals
Intuitive Surgical is recalling Endowrist Instrument and Accessory Manuals for the da Vinci Surgical System to remove the Emergency Grip Release Wrench.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1966-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Vision Troubleshooting Guides
Intuitive Surgical is recalling Vision Troubleshooting Guides for the da Vinci Surgical System to remove references to the Emergency Grip Release Wrench.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1972-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides
Intuitive Surgical is recalling Quick Reference Guides for the da Vinci Surgical System to remove the Emergency Grip Release Wrench from instructions.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1964-2014·2014-07-09
Intuitive Surgical Recalls da Vinci System Manuals Due to Wrench Removal
Intuitive Surgical is recalling da Vinci Surgical System manuals and guides to remove references to the Emergency Grip Release Wrench.
Product
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1973-2014·2014-07-09
Intuitive Surgical Recalls Cautery QRG for da Vinci Surgical Systems
Intuitive Surgical is recalling Cautery Quick Reference Guides for da Vinci systems to update documentation and remove a specific wrench part.
Product
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1974-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides
Intuitive Surgical is recalling Quick Reference Guides for the da Vinci Surgical System to remove the Emergency Grip Release Wrench from the documentation.
Product
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1975-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides
Intuitive Surgical is recalling Natural Rubber Latex Quick Reference Guides for the da Vinci Surgical System to update documentation and remove a specific wrench part.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1971-2014·2014-07-09
Intuitive Surgical Recalls da Vinci Manuals Due to Wrench Removal
Intuitive Surgical is recalling da Vinci Surgical System manuals to remove the Emergency Grip Release Wrench from the documentation.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1969-2014·2014-07-09
Intuitive Surgical Recalls Vessel Sealer Addendum for da Vinci Systems
Intuitive Surgical is recalling Vessel Sealer Addendum software for da Vinci surgical systems to update user manuals and remove the Emergency Grip Release Wrench.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2014·2014-07-02
Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint
Intuitive Surgical is recalling 19 units of the IS4000 da Vinci Xi 0 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.
Product
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1870-2014·2014-07-02
Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint
Intuitive Surgical is recalling 20 units of the IS4000 da Vinci Xi 30 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.
Product
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1718-2014·2014-06-11
Intuitive Surgical da Vinci Patient Side Cart Recall for Torque Wrench Calibration
Intuitive Surgical is recalling two da Vinci Patient Side Cart assemblies because torque wrenches used to tighten bolts were out of calibration, potentially causing system faults or mechanical issues.
Product
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
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1335-2014·2014-04-16
Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use. The recall also includes labeling updates to guide inspection and handling.
Product
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)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1332-2014·2014-04-16
Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.
Product
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)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1333-2014·2014-04-16
Intuitive Surgical Recalls 5mm Curved Cannulae for Potential Damage
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use.
Product
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)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1334-2014·2014-04-16
Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.
Product
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)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0520-2014·2013-12-25
Intuitive Surgical Recalls Mega Needle Drivers for Potential Jaw Detachment
Intuitive Surgical is recalling Mega Needle Drivers for the da Vinci S and Si systems due to a potential risk of jaw insert detachment.
Product
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 o
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Intuitive Surgical

American corporation

Country: United States
Founded: 1995

Official website

Source: Wikidata (Q2743863), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.