Intuitive Surgical, Inc. Recalls
56 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (56)
- Class II
April 2, 2026
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical syst
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
- Class I
March 11, 2026
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
- Class II
December 30, 2025
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
- Class II
December 15, 2025
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Access Port System tray may develop cracks potentially resulting in a sterility breach.
- Class II
December 9, 2025
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Descri
Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
December 9, 2025
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist
Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
December 9, 2025
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: E
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- Class II
December 9, 2025
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist
Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
December 9, 2025
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Desc
Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
December 9, 2025
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- Class II
December 4, 2025
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted p
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
- Class II
November 17, 2025
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
- Class II
November 7, 2025
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinc
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
- Class II
February 26, 2025
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
- Class II
December 19, 2024
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipu
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
- Class II
December 19, 2024
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,COBRA GRASPER,IS4000 REF 471190
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM, POTTS SCISSORS, IS4000 REF 470001
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,FORCE BIPOLAR,IS4000 REF 470405
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,CADIERE FORCEPS,IS4000 REF 471049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,FORCE BIPOLAR,IS4000 REF 471405
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retractio
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
- Class II
December 19, 2024
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
December 19, 2024
8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
August 21, 2024
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
- Class II
July 12, 2024
Ion Endoluminal System, REF: 380748-65
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
- Class II
March 13, 2024
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
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