PlainRecalls

Intuitive Surgical, Inc.

Compiled from official public sources by the publisher.

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

notices

What this shows Intuitive Surgical, Inc. holds about 0.246% of archive notices alongside 257 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jul 22, 2026

da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
FDA Devices Moderate Jul 1, 2026

Da Vinci ASSY, PSS, SP1098, Part Number: 380601
FDA Devices Moderate Jun 10, 2026

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references t
FDA Devices Moderate May 13, 2026

Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USM
FDA Devices Critical May 13, 2026

Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
FDA Devices Moderate Apr 8, 2026

Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, bl
FDA Devices Moderate Apr 8, 2026

Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and

FDA Devices Moderate Apr 8, 2026

Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and

FDA Devices Moderate Apr 8, 2026

Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, c
FDA Devices Moderate Apr 8, 2026

Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cut
FDA Devices Moderate Apr 8, 2026

Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and s
FDA Devices Moderate Feb 25, 2026

Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
FDA Devices Moderate Feb 18, 2026

da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
FDA Devices Moderate Feb 11, 2026

Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four
FDA Devices Moderate Jan 28, 2026

Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to

FDA Devices Moderate Jan 21, 2026

da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
FDA Devices Moderate Dec 31, 2025

da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
FDA Devices Moderate Mar 19, 2025

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
FDA Devices Moderate Jan 22, 2025

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
FDA Devices Moderate Jan 22, 2025

8MM,MEGA SUTURECUT ND,IS4000 REF 471309
FDA Devices Moderate Jan 22, 2025

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
FDA Devices Moderate Jan 22, 2025

8MM,PROGRASP FORCEPS,IS4000 REF 471093
FDA Devices Moderate Jan 22, 2025

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
FDA Devices Moderate Jan 22, 2025

8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
FDA Devices Moderate Jan 22, 2025

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
FDA Devices Moderate Jan 22, 2025

8MM,LONG TIP FORCEPS,IS4000 REF 471048
FDA Devices Moderate Jan 22, 2025

8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
FDA Devices Moderate Jan 22, 2025

8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
FDA Devices Moderate Jan 22, 2025

8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
FDA Devices Moderate Jan 22, 2025

8MM,CADIERE FORCEPS,IS4000 REF 471049
FDA Devices Moderate Jan 22, 2025

8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
FDA Devices Moderate Jan 22, 2025

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
FDA Devices Moderate Jan 22, 2025

8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
FDA Devices Moderate Jan 22, 2025

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
FDA Devices Moderate Jan 22, 2025

8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
FDA Devices Moderate Jan 22, 2025

8MM,FORCE BIPOLAR,IS4000 REF 471405
FDA Devices Moderate Jan 22, 2025

8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
FDA Devices Moderate Jan 22, 2025

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
FDA Devices Moderate Jan 22, 2025

8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
FDA Devices Moderate Jan 22, 2025

8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
FDA Devices Moderate Jan 22, 2025

8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
FDA Devices Moderate Jan 22, 2025

8MM,FORCE BIPOLAR,IS4000 REF 470405
FDA Devices Moderate Jan 22, 2025

8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
FDA Devices Moderate Jan 22, 2025

8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
FDA Devices Moderate Jan 22, 2025

8MM, POTTS SCISSORS, IS4000 REF 470001
FDA Devices Moderate Jan 22, 2025

8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
FDA Devices Moderate Jan 22, 2025

8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
FDA Devices Moderate Jan 22, 2025

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
FDA Devices Moderate Jan 22, 2025

8MM,COBRA GRASPER,IS4000 REF 471190
FDA Devices Moderate Jan 22, 2025

8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318

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).

Hospira Inc. 257 Smith & Nephew, Inc. 258 Biomet, Inc. 255 Hyundai 261 The Anspach Effort, Inc. 261

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Smith & Nephew, Inc. 258 Biomet, Inc. 255 The Anspach Effort, Inc. 261 Maquet Cardiovascular, LLC 252

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