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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261 notices
- Smith & Nephe…
Smith & Nephew, Inc.
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 Jan 22, 2025
8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
FDA Devices Moderate Jan 22, 2025
8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
FDA Devices Moderate Jan 22, 2025
8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
FDA Devices Moderate Jan 22, 2025
8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
FDA Devices Moderate Jan 22, 2025
8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
FDA Devices Moderate Jan 22, 2025
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
FDA Devices Moderate Jan 22, 2025
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
FDA Devices Moderate Sep 4, 2024
Ion Endoluminal System, REF: 380748-65
FDA Devices Moderate Apr 17, 2024
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
FDA Devices Moderate Dec 6, 2023
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
FDA Devices Moderate Jul 12, 2023
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
FDA Devices Moderate Apr 5, 2023
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
FDA Devices Moderate Mar 22, 2023
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
FDA Devices Moderate Dec 7, 2022
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B
FDA Devices Moderate Nov 2, 2022
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
FDA Devices Moderate Aug 10, 2022
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.
FDA Devices Moderate Aug 3, 2022
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
FDA Devices Moderate Aug 3, 2022
Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
FDA Devices Moderate Jun 8, 2022
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
FDA Devices Moderate Jun 8, 2022
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
FDA Devices Moderate May 4, 2022
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460
FDA Devices Moderate Mar 9, 2022
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
FDA Devices Moderate Jan 5, 2022
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A
FDA Devices Moderate Dec 1, 2021
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for s
FDA Devices Moderate Oct 20, 2021
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
FDA Devices Moderate Dec 2, 2020
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12
FDA Devices Moderate Nov 4, 2020
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
FDA Devices Moderate Sep 16, 2020
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
FDA Devices Moderate Sep 16, 2020
ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
FDA Devices Moderate Jun 17, 2020
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
FDA Devices Moderate Jun 17, 2020
STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
FDA Devices Moderate Jun 10, 2020
da Vinci SP surgical system
FDA Devices Moderate Jun 3, 2020
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
FDA Devices Moderate May 20, 2020
da Vinci Xi Surgical System
FDA Devices Moderate May 20, 2020
da Vinci X Surgical System
FDA Devices Moderate May 13, 2020
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
FDA Devices Moderate May 13, 2020
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
FDA Devices Moderate May 13, 2020
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
FDA Devices Moderate May 13, 2020
da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simu
FDA Devices Moderate May 13, 2020
da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope sim
FDA Devices Moderate Feb 12, 2020
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
FDA Devices Moderate Feb 12, 2020
da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
FDA Devices Moderate Feb 12, 2020
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
FDA Devices Moderate Feb 12, 2020
Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
FDA Devices Moderate Feb 5, 2020
The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.
FDA Devices Moderate Nov 6, 2019
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
FDA Devices Moderate Feb 27, 2019
daVinci Harmonic ACE Curved Shears
FDA Devices Moderate Oct 3, 2018
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.
FDA Devices Moderate Sep 19, 2018
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: 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. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instrume
FDA Devices Moderate Sep 19, 2018
da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: 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. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instrume
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