Intuitive Surgical, Inc.

FDA recalling firm · 105 enforcement events · 257 product records · 1930–2026 · CA

Intuitive Surgical, Inc. has 105 FDA enforcement events on this register (257 product records) between 1930 and 2026: 105 device; the busiest year was 2014 with 12.

1% of its events are Class I; the most common class is Class II (103). 35 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
24 Apr 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…	Device	Class II	1	Ongoing
22 Apr 2026	Da Vinci ASSY, PSS, SP1098, Part Number: 380601	Device	Class II	1	Ongoing
2 Apr 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…	Device	Class II	1	Ongoing
11 Mar 2026	Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06	Device	Class I	1	Ongoing
30 Dec 2025	da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45	Device	Class II	1	Ongoing
15 Dec 2025	da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)	Device	Class II	1	Ongoing
9 Dec 2025	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,…	Device	Class II	2	Ongoing
9 Dec 2025	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,…	Device	Class II	4	Ongoing
4 Dec 2025	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…	Device	Class II	1	Ongoing
17 Nov 2025	Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.	Device	Class II	1	Ongoing
7 Nov 2025	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…	Device	Class II	1	Ongoing
12 May 2025	da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15	Device	Class II	1	Ongoing
26 Feb 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	Device	Class II	1	Ongoing
19 Dec 2024	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.	Device	Class II	2	Ongoing
19 Dec 2024	8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179	Device	Class II	37	Ongoing
21 Aug 2024	da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40	Device	Class II	1	Ongoing
12 Jul 2024	Ion Endoluminal System, REF: 380748-65	Device	Class II	1	Ongoing
13 Mar 2024	Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098	Device	Class II	1	Ongoing
6 Oct 2023	Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm	Device	Class II	1	Ongoing
12 Jun 2023	da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12	Device	Class II	1	Ongoing
10 Feb 2023	da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200	Device	Class II	1	Ongoing
24 Jan 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	Device	Class II	1	Ongoing
7 Oct 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…	Device	Class II	1	Ongoing
20 Sep 2022	da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)	Device	Class II	1	Ongoing
1 Jul 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	Device	Class II	2	Ongoing
22 Jun 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.	Device	Class II	1	Completed
17 Mar 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	Device	Class II	1	Ongoing
3 Mar 2022	VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422	Device	Class II	2	Completed
23 Dec 2021	da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11	Device	Class II	1	Ongoing
22 Sep 2021	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	Device	Class II	1	Ongoing
21 Sep 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…	Device	Class II	1	Terminated
6 Aug 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	Device	Class II	1	Terminated
23 Oct 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	Device	Class II	1	Terminated
10 Jun 2020	Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.	Device	Class II	2	Ongoing
19 Dec 2019	STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.	Device	Class II	2	Terminated
19 Aug 2019	da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.	Device	Class II	1	Ongoing
26 Jul 2019	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.	Device	Class II	3	Terminated
1 Jul 2019	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.	Device	Class II	2	Ongoing
17 Jun 2019	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.	Device	Class II	1	Terminated
11 Apr 2019	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…	Device	Class II	2	Terminated
1 Apr 2019	da Vinci SP surgical system	Device	Class II	1	Terminated
16 Jan 2019	daVinci Harmonic ACE Curved Shears	Device	Class II	1	Ongoing
4 Dec 2018	Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298	Device	Class II	1	Terminated
21 Nov 2018	da Vinci Xi Surgical System	Device	Class II	2	Terminated
25 Oct 2018	da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch	Device	Class II	1	Terminated
23 Oct 2018	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…	Device	Class II	1	Terminated
15 Aug 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,…	Device	Class II	2	Ongoing
16 Jul 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…	Device	Class II	1	Terminated
4 Jun 2018	EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.	Device	Class II	1	Ongoing
17 May 2018	The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.	Device	Class II	1	Ongoing
23 Apr 2018	da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.	Device	Class II	2	Terminated
7 Mar 2018	da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors,…	Device	Class II	1	Terminated
19 Sep 2017	daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of…	Device	Class II	1	Terminated
1 Jun 2017	da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon…	Device	Class II	1	Terminated
31 Mar 2017	da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and…	Device	Class II	1	Terminated
15 Mar 2017	STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for…	Device	Class II	16	Terminated
5 Oct 2016	da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: 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 Instruments including rigid…	Device	Class II	1	Terminated
14 Jul 2016	STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General,…	Device	Class II	3	Terminated
14 Jul 2016	STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General,…	Device	Class II	3	Terminated
9 May 2016	SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the…	Device	Class II	2	Terminated
25 Mar 2016	EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: 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 Instruments…	Device	Class II	1	Terminated
16 Mar 2016	da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic…	Device	Class II	2	Terminated
16 Feb 2016	da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac…	Device	Class II	1	Terminated
23 Nov 2015	0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart…	Device	Class II	2	Terminated
9 Sep 2015	Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.	Device	Class II	1	Terminated
17 Aug 2015	da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: 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 Instruments including rigid…	Device	Class II	1	Terminated
8 Aug 2015	Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room…	Device	Class II	9	Terminated
16 Jun 2015	INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. 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 Instruments.	Device	Class II	1	Terminated
21 May 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.	Device	Class II	1	Terminated
16 Mar 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.	Device	Class II	14	Terminated
3 Mar 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…	Device	Class II	3	Terminated
16 Feb 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…	Device	Class II	1	Terminated
11 Feb 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…	Device	Class II	2	Terminated
21 Jan 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	Device	Class II	2	Terminated
15 Jan 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.	Device	Class II	1	Terminated
5 Dec 2014	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…	Device	Class II	1	Terminated
21 Nov 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…	Device	Class II	2	Terminated
3 Nov 2014	8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.	Device	Class II	22	Terminated
18 Sep 2014	EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and…	Device	Class II	1	Terminated
17 Sep 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…	Device	Class II	1	Terminated
11 Sep 2014	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 Instruments including rigid endoscopes, blunt…	Device	Class II	1	Terminated
13 Jun 2014	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	Device	Class II	1	Terminated
11 Jun 2014	IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.	Device	Class II	2	Terminated
2 Jun 2014	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, Gynecologic and Urologic surgery. The device…	Device	Class II	1	Terminated
21 May 2014	System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.	Device	Class II	12	Terminated
9 May 2014	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 arm. The patient-side assistant…	Device	Class II	1	Terminated
13 Mar 2014	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) are indicated for use by trained physicians in…	Device	Class II	4	Terminated
15 Nov 2013	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 of tissue, including: grasping, cutting, blunt…	Device	Class II	2	Terminated
11 Nov 2013	Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model…	Device	Class II	1	Terminated
21 Oct 2013	da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for…	Device	Class III	1	Terminated
2 Oct 2013	Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue,…	Device	Class II	2	Terminated
8 Jun 2013	da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.	Device	Class II	4	Terminated
8 May 2013	8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic…	Device	Class II	1	Terminated
8 May 2013	8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.	Device	Class II	3	Terminated
6 May 2013	da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,	Device	Class II	2	Terminated
15 Mar 2013	IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.	Device	Class II	2	Terminated
24 Jan 2013	User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.	Device	Class II	1	Terminated
9 Aug 2012	Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved…	Device	Class II	1	Terminated
13 Jul 2012	INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.	Device	Class II	6	Terminated
27 Apr 2012	Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086	Device	Class II	1	Terminated
17 Oct 2011	da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.	Device	Class II	1	Terminated
13 Oct 2011	Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical…	Device	Class II	1	Terminated
23 Sep 2011	Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so…	Device	Class II	1	Terminated
19 Sep 2011	Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.	Device	Class II	3	Terminated
11 Dec 1930	Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument…	Device	Class II	1	Terminated

By type and class

Device105

Class II103

Class I1

Class III1

Class I: 1% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Intuitive Surgical, Inc. by year initiated.

Questions and answers

How many FDA recalls has Intuitive Surgical, Inc. had?

105 enforcement events (257 product records) on this register, 1930–2026: 105 device.

Are any Intuitive Surgical, Inc. recalls ongoing?

35 events are listed as ongoing in the current openFDA export.

What class are Intuitive Surgical, Inc. recalls?

103 Class II, 1 Class I, 1 Class III. 1% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.