Intuitive Surgical, Inc.
Intuitive Surgical, Inc. holds FDA 510(k) medical device clearances, first cleared 1997, most recent 2026, with 256 FDA device recalls on record.
Top product codes for Intuitive Surgical, Inc.
FDA recalls by Intuitive Surgical, Inc.
10 most recent of 256- Z-2310-2026 — 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 the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
- Z-2521-2026 — Da Vinci ASSY, PSS, SP1098, Part Number: 380601
- Z-2046-2026 — 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 (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
- Z-1855-2026 — Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
- Z-1355-2026 — da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
- Z-1096-2026 — da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
- Z-1701-2026 — 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, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
- Z-1699-2026 — 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 sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
- Z-1696-2026 — 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, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A
- Z-1697-2026 — 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, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Intuitive Surgical, Inc.
1–100 of 180- K261823 — da Vinci Surgical System, Model IS5000
- K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)
- K261824 — da Vinci Surgical System, Model IS5000
- K261249 — Universal Seal (5-12 mm)
- K253986 — da Vinci Force Feedback Instruments
- K253978 — Universal Seal (5-12 mm)
- K251739 — da Vinci Surgical System (IS5000)
- K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
- K251763 — IRISeg
- K252675 — da Vinci SP Surgical System (SP1098)
- K252069 — da Vinci SP Surgical System (SP1098)
- K251426 — da Vinci SP Surgical System (SP1098)
- K252045 — Ion Endoluminal System (IF1000)
- K251817 — da Vinci SP Surgical System (SP1098)
- K251227 — da Vinci Surgical System (IS5000)
- K252528 — Ion Endoluminal System (IF1000)
- K251324 — da Vinci SP Surgical System (SP1098)
- K252350 — da Vinci SP Firefly Imaging System
- K250442 — da Vinci Surgical System, IS5000
- K251213 — Da Vinci Surgical System (IS5000)
- K251202 — da Vinci Surgical System (IS5000)
- K251490 — 8 mm Assist Cannula; 12 mm Assist Cannula
- K250674 — Vessel Sealer Curved (480522)
- K240852 — da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
- K250786 — SP Endoscope, 0° (430600)
- K243714 — da Vinci SP Surgical System (SP1098)
- K242427 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
- K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
- K243582 — da Vinci SP Advanced Access Port Kit (432701)
- K243641 — da Vinci Surgical System (IS5000)
- K242461 — IRISeg
- K242318 — da Vinci SP Surgical System (SP1098)
- K241814 — da Vinci SP Instruments (SP1098)
- K242070 — Ion Endoluminal System (IF 1000)
- K241638 — 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
- K241360 — Universal Seal (5-12 mm)
- K240502 — da Vinci SP Surgical System (SP1098)
- K241284 — da Vinci Surgical System (IS5000)
- K232773 — da Vinci SP Surgical System (SP1098)
- K240135 — Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)
- K232610 — da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
- K232984 — Ion Endoluminal System (IF1000)
- K231798 — da Vinci SP Surgical System
- K231358 — Universal Seal (5-12 mm)
- K231224 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
- K230033 — Da Vinci SP Surgical System (SP1098)
- K222839 — EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
- K223080 — da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
- K222827 — da Vinci Firefly Imaging System
- K214095 — da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
- K220299 — Ion Endoluminal System (IF1000)
- K213710 — da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
- K220023 — 8mm Monopolar Curved Scissors
- K211997 — 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
- K212101 — da Vinci SP Firefly Imaging System
- K212747 — Da Vinci SP Surgical System
- K212048 — Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
- K211784 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
- K211316 — da Vinci SP Surgical System (SP1098)
- K211595 — da Vinci SP Surgical System (SP1098)
- K210918 — da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
- K203632 — da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
- K202968 — Da Vinci SP Surgical System
- K202834 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
- K202370 — Ion Endoluminal System
- K202571 — da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
- K192717 — da Vinci SP Surgical System
- K201146 — Ion Endoluminal System
- K183086 — da Vinci X and Xi Surgical System
- K192367 — Ion Endoluminal System
- K191280 — E-100 Electrosurgical Generator, SynchroSeal
- K190999 — SureForm 45 Curved Tip, SureForm 45 Gray Reload
- K191043 — da Vinci Handheld Camera
- K182371 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- K183139 — Endoscope Sterilization Tray
- K183107 — Intuitive Surgical Vessel Sealer Extend
- K182140 — da Vinci Xi Surgical System, da Vinci X Surgical System
- K180964 — Endoscope Sterilization Tray
- K180351 — EndoWrist Mercury Bipolar Grasper
- K181395 — Universal Cannula Seal (5-12 mm)
- K173585 — da Vinci Xi Surgical System, da Vinci X Surgical System
- K173415 — EndoWrist 5mm Thoracic Grasper
- K173906 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- K173337 — Intuitive Surgical EndoWrist Vessel Sealer Extend
- K173842 — da Vinci Xi Surgical System, da Vinci X Surgical System
- K180033 — 8mm Monopolar Curved Scissors
- K172643 — da Vinci Xi Surgical System; da Vinci X Surgical System
- K170641 — da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
- K170879 — IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
- K171632 — da Vinci Xi Surgical System
- K170640 — Endoscope Sterilization Tray
- K170875 — da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
- K170644 — da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
- K170645 — da Vinci Xi EndoWrist Instruments and Accessories
- K171699 — da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
- K170713 — da Vinci Xi Surgical System
- K171426 — da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
- K171388 — EndoWrist Stapler 45 System and Stapler 45 Reloads
- K171294 — da Vinci X Surgical System
- K170865 — EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
Data sourced from openFDA. This site is unofficial and independent of the FDA.