Intuitive Surgical Inc

FDA Regulatory Profile

Intuitive Surgical Inc appears in FDA public data with 257 recalls — including 1 Class I (most serious) —, 197 510(k) clearances, 12 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2310-2026, Class II) was initiated on April 24, 2026. Its most recent 510(k) clearance was granted on September 8, 2026.

Summary

Total Recalls
257 (1 Class I)
510(k) Clearances
197
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-2521-2026Class IIDa Vinci ASSY, PSS, SP1098, Part Number: 380601April 22, 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-1699-2026Class IIBrand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping RetrDecember 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-1697-2026Class IIBrand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si DoublDecember 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-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-2722-2026Class IIda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15May 12, 2025
Z-1325-2025Class IIBrand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog NumberFebruary 26, 2025
Z-0880-2025Class II8MM,MEGA SUTURECUT ND,IS4000 REF 471309December 19, 2024
Z-0863-2025Class II8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249December 19, 2024
Z-0924-2025Class II8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi SurgDecember 19, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K261823da Vinci Surgical System, Model IS5000September 8, 2026
K253702Intuitive Endoluminal Gastrointestinal System (IG1000)August 7, 2026
K261824da Vinci Surgical System, Model IS5000July 31, 2026
K261249Universal Seal (5-12 mm)July 14, 2026
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