Intuitive Surgical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
255 (1 Class I)
510(k) Clearances
193
Inspections
12
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2310-2026Class IIBrand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software April 24, 2026
Z-2046-2026Class IIBrand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/CatalogApril 2, 2026
Z-1855-2026Class IIntuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06March 11, 2026
Z-1355-2026Class IIda Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45December 30, 2025
Z-1096-2026Class IIda Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) &December 15, 2025
Z-1701-2026Class IIBrand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si PermanentDecember 9, 2025
Z-1698-2026Class IIBrand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle DDecember 9, 2025
Z-1696-2026Class IIBrand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si MonDecember 9, 2025
Z-1700-2026Class IIBrand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum ForcDecember 9, 2025
Z-1697-2026Class IIBrand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si DoublDecember 9, 2025
Z-1699-2026Class IIBrand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping RetrDecember 9, 2025
Z-1134-2026Class IIBrand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127December 4, 2025
Z-1428-2026Class IIDa Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasiveNovember 17, 2025
Z-1232-2026Class IIBrand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System MNovember 7, 2025
Z-1325-2025Class IIBrand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog NumberFebruary 26, 2025
Z-0852-2025Class II8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036December 19, 2024
Z-0854-2025Class II8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093December 19, 2024
Z-0865-2025Class II8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309December 19, 2024
Z-0874-2025Class II8MM,PROGRASP FORCEPS,IS4000 REF 471093December 19, 2024
Z-0880-2025Class II8MM,MEGA SUTURECUT ND,IS4000 REF 471309December 19, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K260695da Vinci Firefly Imaging SystemMay 22, 2026
K253986da Vinci Force Feedback InstrumentsMarch 11, 2026
K253978Universal Seal (5-12 mm)February 24, 2026
K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorJanuary 16, 2026
K251739da Vinci Surgical System (IS5000)January 16, 2026
K251763IRISegDecember 16, 2025
K252675da Vinci SP Surgical System (SP1098)December 15, 2025
K252069da Vinci SP Surgical System (SP1098)December 2, 2025
K251426da Vinci SP Surgical System (SP1098)October 3, 2025
K252045Ion Endoluminal System (IF1000)September 23, 2025
K251817da Vinci SP Surgical System (SP1098)September 10, 2025
K251227da Vinci Surgical System (IS5000)September 8, 2025
K252528Ion Endoluminal System (IF1000)September 5, 2025
K251324da Vinci SP Surgical System (SP1098)August 29, 2025
K252350da Vinci SP Firefly Imaging SystemAugust 28, 2025
K250442da Vinci Surgical System, IS5000July 29, 2025
K251213Da Vinci Surgical System (IS5000)July 23, 2025
K251202da Vinci Surgical System (IS5000)July 16, 2025
K2514908 mm Assist Cannula; 12 mm Assist CannulaJuly 2, 2025
K250674Vessel Sealer Curved (480522)June 13, 2025