Skip to main content

Is My Product Recalled?

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Scan How It Works Saved Get Alerts

Menu

Search All Recalls Latest Recalls Scan Barcode Get Alerts

Categories

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Resources

How Recalls Work FAQ Recall Classifications Statistics & Trends About

Your Recalls

Loading...

Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

Home
/
Brands
/
Intuitive Surgical, Inc.

Intuitive Surgical, Inc. Recalls

All product recalls associated with Intuitive Surgical, Inc..

Get alerts for this brand

Recall Summary

Total Recalls

105

Past Year

1

Class I (Serious)

0

Most Recent

Feb 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 105 recalls

8MM Long Tip Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Tenaculum Forceps (Intuitive Surgical) – Pitch Cable Failure (2024)

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

FDADec 19, 2024Nationwide• Intuitive Surgical, Inc.

8MM Cadiere Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

123 4...6

Page 2 of 6Next

8MM Monopolar Curved Scissors (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Potts Scissors (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Curved Bipolar Dissector (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Maryland Bipolar Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Large Needle Driver (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Small Graptor (Intuitive Surgical) – Pitch Cable Failure (2024)

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

FDADec 19, 2024Nationwide• Intuitive Surgical, Inc.

8MM Tenaculum Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Fenestrated Bipolar Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

da Vinci 5 Console (Intuitive) – Connector Error (2024)

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

FDAAug 21, 2024Nationwide• Intuitive Surgical, Inc.

Ion Endoluminal System (Intuitive Surgical) – Arm Screw Risk (2024)

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.

FDAJul 12, 2024Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: Patient Cart, Part: 380601, a component of the da Vinci S...

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.

FDAMar 13, 2024AL, CA, CO +18 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: Da Vinci Single-Site Wristed Needle Driver, REF: 478115, ...

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

FDAOct 6, 2023CA, CO, FL +11 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VE...

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 falling into the patient that may be either detected or undetected.

FDAJun 12, 2023Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci Xi Surgical System Model IS4000 da Vinci X Surg...

Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.

FDAFeb 10, 2023Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: Patient Side Cart, REF: 380620, with instrument arms, use...

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 insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

FDAJan 24, 2023Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler ...

Potential staple deployment failure and device fragment generation

FDAOct 7, 2022AZ, CA, CO +21 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci X (IS4200) and Xi (IS4000) systems, which consis...

Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery

FDASep 20, 2022AL, AK, AZ +24 more• Intuitive Surgical, Inc.