Intuitive Surgical, Inc.: Device Recall

Recall #Z-0878-2025 · 12/19/2024

Class II: Risk

Recall Details

Recall Number: Z-0878-2025
Classification: Class II
Product Type: Device
Recalling Firm: Intuitive Surgical, Inc.
Status: Ongoing
Date Initiated: 12/19/2024
Location: Sunnyvale, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 147,006

Reason for Recall

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

Product Description

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205

Distribution Pattern

U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

Other Recalls by Intuitive Surgical, Inc.

Class II: Risk 12/15/2025

Access Port System tray may develop cracks potentially resulting in a sterility breach.
Class II: Risk 12/04/2025

Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Class II: Risk 11/07/2025

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: Risk 02/26/2025

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
Class II: Risk 12/19/2024

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

View all recalls by Intuitive Surgical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.