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U.S. Department of Health and Human Services

Medical Device Recalls
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Firm: Intuitive
 
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Da Vinci ASSY, PSS, SP1098, Part Number: 380601 2 06/22/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software ... 2 06/04/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 1 05/01/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog... 2 05/01/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle D... 2 03/30/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retr... 2 03/30/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Doubl... 2 03/30/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Mon... 2 03/30/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forc... 2 03/30/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent... 2 03/30/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive... 2 02/18/2026 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 2 02/12/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System M... 2 02/02/2026 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127... 2 01/21/2026 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) &... 2 01/15/2026 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730... 2 12/19/2025 FEI # 3001675293
Intuitive Surgical, Inc.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number... 2 03/12/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surg... 2 01/16/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wi... 2 01/16/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM, POTTS SCISSORS, IS4000 REF 470001 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ® REF 470033 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,DEBAKEY FORCEPS,IS4000 ® REF 470036 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,CADIERE FORCEPS,IS4000 ® REF 470049 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 ® REF 470093 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS,IS4000 ® REF 470171 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ® REF 470172 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,RESANO FORCEPS,IS4000 ® REF 470181 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,MEGA NEEDLE DRIVER,IS4000® REF 470194 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000® REF 470205 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,TENACULUM FORCEPS,IS4000® REF 470207 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000® REF 470230 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000® REF 470246 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,DUAL BLADE RETRACTOR,IS4000® REF 470249 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000® REF 470296 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000® REF 470309 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,SMALL GRASPING RETRACTOR,IS4000® REF 470318 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000® REF 470327 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,CURVED BIPOLAR DISSECTOR,IS4000® REF 470344 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,TIP-UP FENESTRATED GRASPER,IS4000® REF 470347 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,HORIZON SMALL CLIP APPLIER,IS4000® REF 470401 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,FORCE BIPOLAR,IS4000 REF 470405 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS,IS4000 REF 471048 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,CADIERE FORCEPS,IS4000 REF 471049 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 471093 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,COBRA GRASPER,IS4000 REF 471190 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM,FORCE BIPOLAR,IS4000 REF 471405 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
8MM, ROUND TIP SCISSORS, IS4000 ® REF 470007 2 01/10/2025 FEI # 3001675293
Intuitive Surgical, Inc.
Ion Endoluminal System, REF: 380748-65 2 08/23/2024 FEI # 3001675293
Intuitive Surgical, Inc.
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 2 04/11/2024 FEI # 3001675293
Intuitive Surgical, Inc.
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm 2 11/28/2023 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 2 06/30/2023 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 2 03/28/2023 FEI # 3001675293
Intuitive Surgical, Inc.
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System... 2 03/16/2023 FEI # 3001675293
Intuitive Surgical, Inc.
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vi... 2 11/30/2022 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC... 2 10/25/2022 FEI # 3001675293
Intuitive Surgical, Inc.
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with ... 2 08/01/2022 FEI # 3001675293
Intuitive Surgical, Inc.
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 42032... 2 07/25/2022 FEI # 3001675293
Intuitive Surgical, Inc.
Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 47032... 2 07/25/2022 FEI # 3001675293
Intuitive Surgical, Inc.
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF... 2 05/31/2022 FEI # 3001675293
Intuitive Surgical, Inc.
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440 2 05/31/2022 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip RE... 2 04/22/2022 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 2 03/01/2022 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/... 2 12/27/2021 FEI # 3001675293
Intuitive Surgical, Inc.
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: th... 2 11/23/2021 FEI # 3001675293
Intuitive Surgical, Inc.
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Ster... 2 10/15/2021 FEI # 3001675293
Intuitive Surgical, Inc.
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the... 2 11/25/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 0088687411419... 2 10/23/2020 FEI # 3001675293
Intuitive Surgical, Inc.
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845. 2 09/10/2020 FEI # 3001675293
Intuitive Surgical, Inc.
ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includ... 2 09/10/2020 FEI # 3001675293
Intuitive Surgical, Inc.
STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is... 2 06/09/2020 FEI # 3001675293
Intuitive Surgical, Inc.
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is de... 2 06/09/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci SP surgical system 2 06/03/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery. 2 06/01/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci Xi Surgical System 2 05/11/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci X Surgical System 2 05/11/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch 2 05/06/2020 FEI # 3001675293
Intuitive Surgical, Inc.
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx O... 2 05/05/2020 FEI # 3001675293
Intuitive Surgical, Inc.
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx o... 2 05/05/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made... 2 05/05/2020 FEI # 3001675293
Intuitive Surgical Inc
da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is mad... 2 05/05/2020 FEI # 3001675293
Intuitive Surgical Inc
Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112... 2 02/06/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an en... 2 01/31/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical... 2 01/31/2020 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endo... 2 01/31/2020 FEI # 3001675293
Intuitive Surgical, Inc.
The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Visi... 2 01/24/2020 FEI # 3001675293
Intuitive Surgical, Inc.
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the ... 2 10/30/2019 FEI # 3001675293
Intuitive Surgical, Inc.
daVinci Harmonic ACE Curved Shears 2 02/15/2019 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci... 2 09/26/2018 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWri... 2 09/12/2018 FEI # 3001675293
Intuitive Surgical, Inc.
da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWri... 2 09/12/2018 FEI # 3001675293
Intuitive Surgical, Inc.
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: ... 2 08/16/2018 FEI # 3001675293
Intuitive Surgical, Inc.
 
 
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