← Every firm
Intuitive Surgical, Inc. FDA Recalls
75 recalls on file across devices, 1 of them Class I and 70 still open. Matched by name to ISRG.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A ProducClass IIApr 24, 2026Due to unintentionally activated near infrared handheld came |
| Da Vinci ASSY, PSS, SP1098, Part Number: 380601Class IIApr 22, 2026Operative components of surgical systems potentially distrib |
| Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4Class IIApr 2, 2026Due to manipulator containing screws with in the arm sub-ass |
| Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Class IMar 11, 2026Reloads for curved-tipped stapler may potentially produce an |
| da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45Class IIDec 30, 2025Robotic-assisted surgical system has Viewer Display manufact |
| da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1Class IIDec 15, 2025Access Port System tray may develop cracks potentially resu |
| Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved ScissoClass IIDec 9, 2025Due to increased complaints for broken/frayed grip cables fo |
| Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook InstruClass IIDec 9, 2025Due to increased in complaints regarding frayed or broken pi |
| Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated GraspeClass IIDec 9, 2025Due to increased complaints for broken/frayed grip cables fo |
| Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument ModeClass IIDec 9, 2025Due to increased in complaints regarding frayed or broken pi |
| Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument MoClass IIDec 9, 2025Due to increased complaints for broken/frayed grip cables fo |
| Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument MoClass IIDec 9, 2025Due to increased complaints for broken/frayed grip cables fo |
| Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: Class IIDec 4, 2025Due to probe bags that may have a compromised or incomplete |
| Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.Class IINov 17, 2025An error event following the release of a software version f |
| Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number:Class IINov 7, 2025Due to a software implementation error that allowed instrume |
| da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15Class IIMay 12, 2025Robotic-assisted surgical system arm drapes may detach from |
| Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software VClass IIFeb 26, 2025Due to an increase in complaints concerning foot tray pedal |
| 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,MEGA SUTURECUT ND,IS4000 REF 471309Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,PROGRASP FORCEPS,IS4000 REF 471093Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,FORCE BIPOLAR,IS4000 REF 470405Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,FORCE BIPOLAR,IS4000 REF 471405Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,LONG TIP FORCEPS,IS4000 REF 471048Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,CADIERE FORCEPS,IS4000 REF 471049Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wiClass IIDec 19, 2024Due to an increase in complaints for pitch cable failures re |
| 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM, POTTS SCISSORS, IS4000 REF 470001Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedClass IIDec 19, 2024Due to an increase in complaints for pitch cable failures re |
| 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,COBRA GRASPER,IS4000 REF 471190Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400Class IIDec 19, 2024Due to increased complaints regarding frayed or broken grip |
| da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40Class IIAug 21, 2024Surgical system Error 23062 due to connector1) Partially dam |
| Ion Endoluminal System, REF: 380748-65Class IIJul 12, 2024There is a potential that the robotic system's instrument c |
| Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098Class IIMar 13, 2024Surgical system may have inadequately welded top and/or bott |
| Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mmClass IIOct 6, 2023There is the potential for the needle drive to become dislod |
| da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12Class IIJun 12, 2023Fenestrated Graspers have a manufacturing issue has the pote |
| da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200Class IIFeb 10, 2023Due to Universal Surgical Manipulator (USM) instrument carri |
| Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; PaClass IIJan 24, 2023Preventative maintenance data was used to identify instrumen |
| INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Class IIOct 7, 2022Potential staple deployment failure and device fragment gene |
| da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCClass IISep 20, 2022Inadvertent energy delivery from surgical system instrument |
| Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi SmaClass IIJul 1, 2022Due to the potential for unexpected motion caused by the par |
| Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si SmaClass IIJul 1, 2022Due to the potential for unexpected motion caused by the par |
| The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and Class IIJun 22, 2022Due to preventative maintenance (PM) not being performed on |
| da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da VinicClass IIMar 17, 2022As a result of complaint data review, it identified tissue p |
| VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422Class IIMar 3, 2022Placing excessive tissue in the instrument jaws of the devic |
| DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440Class IIMar 3, 2022Placing excessive tissue in the instrument jaws of the devic |
| da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11Class IIDec 23, 2021Conductive Cannula Reducer metal tip may get dislodged from |
| da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874Class IISep 22, 2021Issue was identified during internal engineering evaluation. |
| The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SClass IISep 21, 2021Incorrect expiration date on its package labeling (shipper b |
| Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDIClass IIAug 6, 2021Potential for the sheath tip on the biopsy needle to separat |