Brand

Intuitive Surgical, Inc. Recalls

168 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Intuitive Surgical, Inc..

168Total Recalls
3Critical
5.3MUnits Affected
Apr 2, 2026Most Recent
All Recalls

Every Intuitive Surgical, Inc. Recall

Sorted by most recent. Click any recall for full details.

168 recalls
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Ver...
Surgical Devices·2,781 affected·Apr 2, 2026
High RiskFDA
Intuitive Surgical, Inc.
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Medical Devices·47 affected·Dec 30, 2025
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Medical Devices·41,526 affected·Dec 15, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catal...
Surgical Devices·6,152 affected·Dec 9, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Numbe...
Surgical Devices·7,819 affected·Dec 9, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Numbe...
Surgical Devices·2,660 affected·Dec 9, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Mo...
Surgical Devices·86,904 affected·Dec 9, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . ...
Medical Devices·439 affected·Feb 26, 2025
High RiskFDA
Intuitive Surgical, Inc.
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Medical Devices·5,576 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Medical Devices·88,840 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Medical Devices·10,603 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Surgical Devices·99,249 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Medical Devices·355,547 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Medical Devices·738 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Surgical Devices·12,340 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Surgical Devices·1,562 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Surgical Devices·1,111 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Surgical Devices·373 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Medical Devices·38,438 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,CADIERE FORCEPS,IS4000 REF 471049
Surgical Devices·56,580 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Surgical Devices·2,852 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Surgical Devices·7,132 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Surgical Devices·1,739 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Surgical Devices·68,458 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of pro...
Surgical Devices·42,028 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,FORCE BIPOLAR,IS4000 REF 471405
Medical Devices·46,759 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a...
Surgical Devices·33,219 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Medical Devices·29,723 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Medical Devices·3,869 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Medical Devices·144 affected·Aug 21, 2024
High RiskFDA
Intuitive Surgical, Inc.
Ion Endoluminal System, REF: 380748-65
Medical Devices·3 affected·Jul 12, 2024
High RiskFDA
Intuitive Surgical, Inc.
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Medical Devices·317 affected·Oct 6, 2023
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Medical Devices·46,033 affected·Jun 12, 2023
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Surgical Devices·1,225 affected·Feb 10, 2023
High RiskFDA
Intuitive Surgical, Inc.
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, ...
Surgical Devices·9 affected·Jan 24, 2023
High RiskFDA
Intuitive Surgical, Inc.
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...
Medical Devices·160 affected·Oct 7, 2022
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision Syst...
Medical Devices·162 affected·Sep 20, 2022
High RiskFDA
Intuitive Surgical, Inc.
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, ...
Medical Devices·62,895 affected·Jul 1, 2022
High RiskFDA
Intuitive Surgical, Inc.
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-...
Surgical Devices·505 affected·Jun 22, 2022
High RiskFDA
Intuitive Surgical, Inc.
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 ...
Medical Devices·68,881 affected·Mar 17, 2022
High RiskFDA
Intuitive Surgical, Inc.
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Medical Devices·140,519 affected·Mar 3, 2022
High RiskFDA
Intuitive Surgical, Inc.
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Medical Devices·7,995 affected·Mar 3, 2022
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Medical Devices·149,646 affected·Dec 23, 2021
High RiskFDA
Intuitive Surgical, Inc.
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Ca...
Surgical Devices·1,740 affected·Sep 21, 2021
High RiskFDA
Intuitive Surgical, Inc.
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Medical Devices·1,625 affected·Aug 6, 2021
High RiskFDA
Intuitive Surgical, Inc.
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter with...
Surgical Devices·454 affected·Oct 23, 2020
High RiskFDA
Intuitive Surgical, Inc.
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Surgical Devices·67 affected·Jun 10, 2020
High RiskFDA
Intuitive Surgical, Inc.
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery usin...
Medical Devices·1,757 affected·Dec 19, 2019