FDA recall record · openFDA
Intuitive Surgical, Inc.
61 FDA recalls on record (2023–2026) — 61 device. 61 still ongoing.
1
Class I (most serious)
60
Class II
0
Class III
61
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. 37
Due to increased complaints for broken/frayed grip cables for reusable instruments. 4
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments 2
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments 2
Access Port System tray may develop cracks potentially resulting in a sterility breach. 1
Recalls
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 Class I 2026-03-11 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Produc Class II 2026-04-24 Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4 Class II 2026-04-02 Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instru Class II 2025-12-09 da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1 Class II 2025-12-15 Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Mo Class II 2025-12-09 da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 Class II 2025-12-30 Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Mo Class II 2025-12-09 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software V Class II 2025-02-26 Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scisso Class II 2025-12-09 Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery. Class II 2025-11-17 Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Graspe Class II 2025-12-09 Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Mode Class II 2025-12-09 Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: Class II 2025-12-04 Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: Class II 2025-11-07 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401 Class II 2024-12-19 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 Class II 2024-12-19 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 Class II 2024-12-19 8MM,PROGRASP FORCEPS,IS4000 REF 471093 Class II 2024-12-19 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 Class II 2024-12-19 Ion Endoluminal System, REF: 380748-65 Class II 2024-07-12 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246 Class II 2024-12-19 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205 Class II 2024-12-19 8MM,LONG TIP FORCEPS,IS4000 REF 471048 Class II 2024-12-19 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033 Class II 2024-12-19 da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40 Class II 2024-08-21 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181 Class II 2024-12-19 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194 Class II 2024-12-19 8MM,CADIERE FORCEPS,IS4000 REF 471049 Class II 2024-12-19 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093 Class II 2024-12-19 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172 Class II 2024-12-19 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036 Class II 2024-12-19 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 Class II 2024-12-19 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wi Class II 2024-12-19 8MM,FORCE BIPOLAR,IS4000 REF 471405 Class II 2024-12-19 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of proced Class II 2024-12-19 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 Class II 2024-12-19 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 Class II 2024-12-19 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 Class II 2024-12-19 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007 Class II 2024-12-19 8MM,FORCE BIPOLAR,IS4000 REF 470405 Class II 2024-12-19 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344 Class II 2024-12-19 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230 Class II 2024-12-19 8MM, POTTS SCISSORS, IS4000 REF 470001 Class II 2024-12-19 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327 Class II 2024-12-19 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171 Class II 2024-12-19 Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 Class II 2024-03-13 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296 Class II 2024-12-19 8MM,COBRA GRASPER,IS4000 REF 471190 Class II 2024-12-19 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318 Class II 2024-12-19 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347 Class II 2024-12-19 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249 Class II 2024-12-19 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049 Class II 2024-12-19 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207 Class II 2024-12-19 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309 Class II 2024-12-19 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 Class II 2024-12-19 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 Class II 2024-12-19 Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm Class II 2023-10-06 Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Pa Class II 2023-01-24 da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 Class II 2023-02-10 da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 Class II 2023-06-12
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.