Home / Brands / Intuitive Surgical
Intuitive Surgical Recalls
257 recalls on record · August 8, 2012 to July 22, 2026 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 22, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Hazard: Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
July 1, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Hazard: Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
June 10, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Produc
Hazard: Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
May 13, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4
Hazard: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
May 13, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Hazard: Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instru
Hazard: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Mode
Hazard: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Mo
Hazard: Due to increased complaints for broken/frayed grip cables for reusable instruments.
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Mo
Hazard: Due to increased complaints for broken/frayed grip cables for reusable instruments.
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Graspe
Hazard: Due to increased complaints for broken/frayed grip cables for reusable instruments.
April 8, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scisso
Hazard: Due to increased complaints for broken/frayed grip cables for reusable instruments.
February 25, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Hazard: 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.
February 18, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Hazard: 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.
February 11, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number:
Hazard: 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
January 28, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version:
Hazard: Due to probe bags that may have a compromised or incomplete sterile pouch seal.
January 21, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1
Hazard: Access Port System tray may develop cracks potentially resulting in a sterility breach.
December 31, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Hazard: 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
March 19, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software V
Hazard: Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wi
Hazard: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of proced
Hazard: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,FORCE BIPOLAR,IS4000 REF 471405
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,COBRA GRASPER,IS4000 REF 471190
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,PROGRASP FORCEPS,IS4000 REF 471093
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.