Intuitive Surgical, Inc.
169 recalls on record · Latest: Jan 21, 2026
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 H…
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 p…
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 …
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 Sep 4, 2024
Ion Endoluminal System, REF: 380748-65
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,…
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 m…
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 insta…
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 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 …
FDA Devices Moderate Mar 9, 2022
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
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…
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 …
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 …
FDA Devices Moderate Sep 16, 2020
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
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 minimall…
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 b…
FDA Devices Moderate May 13, 2020