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
- The Anspach E…
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261 notices
- Smith & Nephe…
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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 Jun 24, 2015
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
FDA Devices Moderate Apr 15, 2015
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Devices Moderate Apr 1, 2015
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipu
FDA Devices Moderate Apr 1, 2015
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic mani
FDA Devices Moderate Apr 1, 2015
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissu
FDA Devices Moderate Mar 11, 2015
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.
FDA Devices Moderate Mar 4, 2015
EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05
FDA Devices Moderate Mar 4, 2015
EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
FDA Devices Moderate Feb 25, 2015
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
FDA Devices Moderate Feb 25, 2015
HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
FDA Devices Moderate Feb 11, 2015
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Jan 14, 2015
IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) 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, endos
FDA Devices Moderate Dec 31, 2014
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 31, 2014
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Dec 3, 2014
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Devices Moderate Oct 22, 2014
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 for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
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