Intuitive Surgical, Inc.
Sunnyvale, CA
This page shows every FDA and USDA recall linked to Intuitive Surgical, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
266
Total Recalls
0012
First Recall
2026
Most Recent
Da Vinci 5
ASSY, DV5 CONSOLE, IS5000
Model/Catalog Number: 380730
Used for minimally invasive surgery.
Feb 18, 2026
· Device
Open, Classified
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Feb 12, 2026
· Device
Open, Classified
Brand Name: Da Vinci
Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System
Model/Catalog...
Feb 2, 2026
· Device
Open, Classified
Brand Name: Ion Endoluminal System
Product Name: Ion Vision Probe Bag
Model/Catalog Number: 490127
Software Ve...
Jan 21, 2026
· Device
Open, Classified
da Vinci SP, SP Access Port Kit, Large Incision
Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7...
Jan 15, 2026
· Device
Open, Classified
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Dec 19, 2025
· Device
Open, Classified
Brand Name: Da Vinci 5
Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals
Model/Catalog Number: 380730
Sof...
Mar 12, 2025
· Device
Open, Classified
8MM, Small Graptor REF 470318
Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems...
Jan 16, 2025
· Device
Open, Classified
8MM, Tenaculum Forceps REF 470207
Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety o...
Jan 16, 2025
· Device
Open, Classified
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Jan 10, 2025
· Device
Open, Classified
8MM, POTTS SCISSORS, IS4000 REF 470001
Jan 10, 2025
· Device
Open, Classified
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172
Jan 10, 2025
· Device
Open, Classified
8MM,MEGA SUTURECUT ND,IS4000 REF 470309
Jan 10, 2025
· Device
Open, Classified
8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194
Jan 10, 2025
· Device
Open, Classified
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Jan 10, 2025
· Device
Open, Classified
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344
Jan 10, 2025
· Device
Open, Classified
8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318
Jan 10, 2025
· Device
Open, Classified
8MM,PROGRASP FORCEPS,IS4000 REF 470093
Jan 10, 2025
· Device
Open, Classified
8MM,RESANO FORCEPS,IS4000 REF 470181
Jan 10, 2025
· Device
Open, Classified
8MM, ROUND TIP SCISSORS, IS4000 REF 470007
Jan 10, 2025
· Device
Open, Classified
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Jan 10, 2025
· Device
Open, Classified
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Jan 10, 2025
· Device
Open, Classified
8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249
Jan 10, 2025
· Device
Open, Classified
8MM,FORCE BIPOLAR,IS4000 REF 470405
Jan 10, 2025
· Device
Open, Classified
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Jan 10, 2025
· Device
Open, Classified
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Jan 10, 2025
· Device
Open, Classified
8MM,COBRA GRASPER,IS4000 REF 471190
Jan 10, 2025
· Device
Open, Classified
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Jan 10, 2025
· Device
Open, Classified
8MM,TENACULUM FORCEPS,IS4000 REF 470207
Jan 10, 2025
· Device
Open, Classified
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296
Jan 10, 2025
· Device
Open, Classified
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246
Jan 10, 2025
· Device
Open, Classified
8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347
Jan 10, 2025
· Device
Open, Classified
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Jan 10, 2025
· Device
Open, Classified
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Jan 10, 2025
· Device
Open, Classified
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171
Jan 10, 2025
· Device
Open, Classified
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Jan 10, 2025
· Device
Open, Classified
8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401
Jan 10, 2025
· Device
Open, Classified
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205
Jan 10, 2025
· Device
Open, Classified
8MM,CADIERE FORCEPS,IS4000 REF 471049
Jan 10, 2025
· Device
Open, Classified
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230
Jan 10, 2025
· Device
Open, Classified
8MM,CADIERE FORCEPS,IS4000 REF 470049
Jan 10, 2025
· Device
Open, Classified
8MM,DEBAKEY FORCEPS,IS4000 REF 470036
Jan 10, 2025
· Device
Open, Classified
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Jan 10, 2025
· Device
Open, Classified
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327
Jan 10, 2025
· Device
Open, Classified
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033
Jan 10, 2025
· Device
Open, Classified
8MM,FORCE BIPOLAR,IS4000 REF 471405
Jan 10, 2025
· Device
Open, Classified
Ion Endoluminal System, REF: 380748-65
Aug 23, 2024
· Device
Open, Classified
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Apr 11, 2024
· Device
Open, Classified
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Nov 28, 2023
· Device
Open, Classified
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Jun 30, 2023
· Device
Open, Classified