Intuitive Surgical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
246
510(k) Clearances
192
Inspections
11
Compliance Actions
1

Recent Recalls

NumberClassProductDate
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-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-0847-2025Class II8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179December 19, 2024
Z-0881-2025Class II8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344December 19, 2024
Z-0865-2025Class II8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309December 19, 2024
Z-0857-2025Class II8MM,RESANO FORCEPS,IS4000 ¿ REF 470181December 19, 2024
Z-0850-2025Class II8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007December 19, 2024
Z-0883-2025Class II8MM,FORCE BIPOLAR,IS4000 REF 471405December 19, 2024
Z-0870-2025Class II8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401December 19, 2024
Z-0879-2025Class II8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296December 19, 2024
Z-0852-2025Class II8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036December 19, 2024
Z-0851-2025Class II8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033December 19, 2024
Z-0871-2025Class II8MM,FORCE BIPOLAR,IS4000 REF 470405December 19, 2024
Z-0860-2025Class II8MM,TENACULUM FORCEPS,IS4000¿ REF 470207December 19, 2024
Z-0859-2025Class II8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205December 19, 2024
Z-0873-2025Class II8MM,CADIERE FORCEPS,IS4000 REF 471049December 19, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K253986da Vinci Force Feedback InstrumentsMarch 11, 2026
K253978Universal Seal (5-12 mm)February 24, 2026
K251739da Vinci Surgical System (IS5000)January 16, 2026
K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorJanuary 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
K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)June 11, 2025