Intuitive Surgical, Inc. recalls
105 recalls in our records from 2012 to 2026: 105 FDA medical devices.
Recalls with full detail pages
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Intuitive Surgical, Inc. medical device recall: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05…
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Earlier and other recalls
These link to the official agency notice.
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Intuitive Surgical, Inc. medical device recall: da Vinci SP Instrument Arm Drape Official notice ↗
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…
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Intuitive Surgical, Inc. medical device recall: Da Vinci ASSY Official notice ↗
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…
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Intuitive Surgical, Inc. medical device recall: Brand Name: Da Vinci 5 Product Name: ASSY Official notice ↗
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when…
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Intuitive Surgical, Inc. medical device recall: Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X Official notice ↗
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
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Intuitive Surgical, Inc. medical device recall: Brand Name: da Vinci S Official notice ↗
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
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Intuitive Surgical, Inc. medical device recall: Brand Name: da Vinci S Official notice ↗
Due to increased complaints for broken/frayed grip cables for reusable instruments.
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Intuitive Surgical, Inc. medical device recall: Da Vinci 5 ASSY Official notice ↗
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…
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Intuitive Surgical, Inc. medical device recall: da Vinci 5 Surgeon Console Viewer Display Official notice ↗
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)…
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Intuitive Surgical, Inc. medical device recall: Brand Name: Da Vinci Product Name: da Vinci X Official notice ↗
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…
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Intuitive Surgical, Inc. medical device recall: Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag… Official notice ↗
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
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Intuitive Surgical, Inc. medical device recall: da Vinci SP Official notice ↗
Access Port System tray may develop cracks potentially resulting in a sterility breach.
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Intuitive Surgical, Inc. medical device recall: da Vinci 5 Official notice ↗
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer,…
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Intuitive Surgical, Inc. medical device recall: Brand Name: Da Vinci 5 Product Name: ASSY Official notice ↗
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
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Intuitive Surgical, Inc. medical device recall: 8Mm Official notice ↗
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
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Intuitive Surgical, Inc. medical device recall: 8Mm Official notice ↗
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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Intuitive Surgical, Inc. medical device recall: Ion Endoluminal System Official notice ↗
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…
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Intuitive Surgical, Inc. medical device recall: Patient Cart Official notice ↗
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…
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Intuitive Surgical, Inc. medical device recall: Da Vinci Single-Site Wristed Needle Driver Official notice ↗
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi/X Tip-Up Fenestrated Grasper Official notice ↗
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments…
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System… Official notice ↗
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
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Intuitive Surgical, Inc. medical device recall: Patient Side Cart Official notice ↗
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of…
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Intuitive Surgical, Inc. medical device recall: INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci… Official notice ↗
Potential staple deployment failure and device fragment generation
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Intuitive Surgical, Inc. medical device recall: da Vinci X Official notice ↗
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad…
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Intuitive Surgical, Inc. medical device recall: The E-100 Generator Official notice ↗
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X…
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Intuitive Surgical, Inc. medical device recall: Da Vinci S/Si Large Clip Applier Official notice ↗
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
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Intuitive Surgical, Inc. medical device recall: Vessel Sealer Extend Official notice ↗
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
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Intuitive Surgical, Inc. medical device recall: da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi… Official notice ↗
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws,…
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi and X 12-8 mm Conductive Cannula Reducer Official notice ↗
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure…
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Intuitive Surgical, Inc. medical device recall: da Vinci SP Surgical systems with the following Model Name/ Model… Official notice ↗
Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or…
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Intuitive Surgical, Inc. medical device recall: The da Vinci Xi and X surgical systems Official notice ↗
Incorrect expiration date on its package labeling (shipper box and inner carton label).
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Intuitive Surgical, Inc. medical device recall: Ion Flexison Biopsy Needle Official notice ↗
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
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Intuitive Surgical, Inc. medical device recall: Box Label: ION Fully Articulating Catheter Official notice ↗
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
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Intuitive Surgical, Inc. medical device recall: da Vinci Surgical System Official notice ↗
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the…
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Intuitive Surgical, Inc. medical device recall: Ion Catheter Reprocessing Cover Official notice ↗
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter…
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Intuitive Surgical, Inc. medical device recall: Stainless Steel Reprocessing Tray Official notice ↗
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a…
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Intuitive Surgical, Inc. medical device recall: da Vinci SP surgical system Official notice ↗
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has…
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Intuitive Surgical, Inc. medical device recall: da Vinci SP Camera Official notice ↗
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a…
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi Surgical System Official notice ↗
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
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Intuitive Surgical, Inc. medical device recall: daVinci XI Sureform 60 reload Official notice ↗
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could…
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Intuitive Surgical, Inc. medical device recall: da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch Official notice ↗
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
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Intuitive Surgical Inc medical device recall: da Vinci Xi Surgical System Official notice ↗
Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and…
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi Surgical System Surgical System Official notice ↗
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient…
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Intuitive Surgical, Inc. medical device recall: Da Vinci Xi/X EndoWrist Monopolar Curved scissors Official notice ↗
This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits…
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Intuitive Surgical, Inc. medical device recall: The da Vinci SP surgical system is made of three main components: the… Official notice ↗
The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.
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Intuitive Surgical, Inc. medical device recall: EndoWrist Suction Irrigator Official notice ↗
The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the…
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Intuitive Surgical, Inc. medical device recall: daVinci Harmonic ACE Curved Shears Official notice ↗
During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential…
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Intuitive Surgical, Inc. medical device recall: da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply Official notice ↗
Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during…
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Intuitive Surgical, Inc. medical device recall: da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No.… Official notice ↗
Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic…
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Intuitive Surgical, Inc. medical device recall: The da Vinci Xi Surgical System Official notice ↗
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images…
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi EndoWrist Stapler 45 Reload Blue Official notice ↗
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife…
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Intuitive Surgical, Inc. medical device recall: da Vinci X Surgical System Official notice ↗
Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a…
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Intuitive Surgical, Inc. medical device recall: daVinci X EndoWrist(R) Stapler 45 Official notice ↗
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a…
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical… Official notice ↗
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi EndoWrist Suction Irrigator Official notice ↗
Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience…
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Intuitive Surgical, Inc. medical device recall: Stapler Official notice ↗
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit…
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Intuitive Surgical, Inc. medical device recall: da Vinci¿ Xi" Surgical System Official notice ↗
Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement…
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Intuitive Surgical, Inc. medical device recall: Stapler Official notice ↗
Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or…
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Intuitive Surgical, Inc. medical device recall: Stapler 45 Official notice ↗
An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi…
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Intuitive Surgical, Inc. medical device recall: Seal Official notice ↗
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when…
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Intuitive Surgical, Inc. medical device recall: EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci… Official notice ↗
Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly…
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Intuitive Surgical, Inc. medical device recall: da Vinci S Surgical System Official notice ↗
Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes…
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Intuitive Surgical, Inc. medical device recall: da Vinci Si Official notice ↗
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Intuitive Surgical, Inc. medical device recall: 0 deg Official notice ↗
This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae,…
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Intuitive Surgical, Inc. medical device recall: Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi… Official notice ↗
B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears…
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Intuitive Surgical, Inc. medical device recall: Maryland Dissector Official notice ↗
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi Surgical System P4 software Official notice ↗
Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
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Intuitive Surgical, Inc. medical device recall: Instrument Arm Drape Official notice ↗
Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a…
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Intuitive Surgical, Inc. medical device recall: Thoracic Grasper Official notice ↗
The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into…
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Intuitive Surgical, Inc. medical device recall: da Vinci S Surgical System IS2000 Official notice ↗
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
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Intuitive Surgical, Inc. medical device recall: da Vinci Xi Surgical System Official notice ↗
Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the…
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Intuitive Surgical, Inc. medical device recall: Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S Official notice ↗
There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small…
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Intuitive Surgical, Inc. medical device recall: EndoWrist One Vessel Sealer Official notice ↗
Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to…
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Intuitive Surgical, Inc. medical device recall: HARMONIC ACE Curved Shears Instructions for Use Official notice ↗
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
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Intuitive Surgical, Inc. medical device recall: da Vinci Si Surgical System Official notice ↗
The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to…
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Intuitive Surgical, Inc. medical device recall: IS3000 Vision Side Cart Official notice ↗
Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the…
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Intuitive Surgical, Inc. medical device recall: Fluorescence Imaging Procedure Kit Official notice ↗
The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were…
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Intuitive Surgical, Inc. medical device recall: 8Mm Official notice ↗
Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of…
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Intuitive Surgical, Inc. medical device recall: EndoWrist Stapler 45 instrument for the da Vinci Si System Model… Official notice ↗
Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.
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Intuitive Surgical, Inc. medical device recall: EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si… Official notice ↗
Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si…
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Intuitive Surgical, Inc. medical device recall: Assembly Official notice ↗
Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.
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Intuitive Surgical, Inc. medical device recall: EndoWrist Stapler System User Manual Addendum and Wall Chart Official notice ↗
Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN…
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Intuitive Surgical, Inc. medical device recall: Patient Side Cart Battery Box used in conjunction with the da Vinci A… Official notice ↗
Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
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Intuitive Surgical, Inc. medical device recall: Intuitive Surgical Inc. Large Clip Applier instruments used in… Official notice ↗
Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with…
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Intuitive Surgical, Inc. medical device recall: System Manual for the da Vinci Standard Surgical System Official notice ↗
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System,…
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Intuitive Surgical, Inc. medical device recall: IS4000 da Vinci Xi - Endoscope accessory Official notice ↗
In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to…
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Intuitive Surgical, Inc. medical device recall: Patient Side Cart assembly Official notice ↗
Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults,…
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Intuitive Surgical, Inc. medical device recall: 5X300 MM Curved Cannula Official notice ↗
Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action…
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Intuitive Surgical, Inc. medical device recall: Mega Needle Driver Official notice ↗
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
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Intuitive Surgical, Inc. medical device recall: Assembly Official notice ↗
Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In…
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Intuitive Surgical, Inc. medical device recall: da Vinci Vision System Cart Official notice ↗
Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red…
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Intuitive Surgical, Inc. medical device recall: Patient Cart used in conjunction with the da Vinci S surgical and SI… Official notice ↗
Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.
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Intuitive Surgical, Inc. medical device recall: Single Site Bipolar Maryland Forceps Intuitive Surgical Official notice ↗
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the…
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Intuitive Surgical, Inc. medical device recall: da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console… Official notice ↗
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
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Intuitive Surgical, Inc. medical device recall: da Vinci Si Surgeon Side Cart Official notice ↗
Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
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Intuitive Surgical, Inc. medical device recall: 8 mm Monopolar Curved Scissors Official notice ↗
Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal…
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Intuitive Surgical, Inc. medical device recall: da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si… Official notice ↗
Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN…
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Intuitive Surgical, Inc. medical device recall: 8mm Precise Bipolar Forceps used in conjunction with the da Vinci… Official notice ↗
Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of…
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Intuitive Surgical, Inc. medical device recall: User Manual addendum Official notice ↗
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
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Intuitive Surgical, Inc. medical device recall: Cannula 8MM Regular. Provides the means of introduction and placement… Official notice ↗
Clarification of existing labeling information and operating procedures.
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Intuitive Surgical, Inc. medical device recall: Tip Cover Accessory Official notice ↗
Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.