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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
Recalled January 21, 2026 · FDA recall Z-1096-2026 · Intuitive Surgical
Hazard
Access Port System tray may develop cracks potentially resulting in a sterility breach. · FDA Class II
Units
41,526 units
Sold at
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.
Description
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Product
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →