Intuitive Surgical, Inc.: Device Recall

Recall #Z-1096-2026 · 12/15/2025

Class II: Risk

Recall Details

Recall Number: Z-1096-2026
Classification: Class II
Product Type: Device
Recalling Firm: Intuitive Surgical, Inc.
Status: Ongoing
Date Initiated: 12/15/2025
Location: Sunnyvale, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 41,526 units

Reason for Recall

Access Port System tray may develop cracks potentially resulting in a sterility breach.

Product Description

da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.

Other Recalls by Intuitive Surgical, Inc.

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.
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.