FDA-Device2026-01-21Class IIPACKAGING DEFECT
Intuitive Surgical da Vinci SP Access Port Kit recalled for potential sterility breach
OTHERNationwide distribution
Check da Vinci SP Access Port Kit lot numbers
Intuitive Surgical is recalling certain da Vinci SP Access Port Kits because the sterile trays may develop cracks during storage or handling. A cracked tray could allow bacteria or other contaminants to enter, compromising the sterile field during surgery. No injuries have been reported.
- Check if your facility has affected lot numbers (listed on the FDA notice)
- Stop using any Access Port Kit trays with the recalled lot numbers
- Contact Intuitive Surgical or your supplier for replacement trays
- Review any recent procedures using affected lots and consult infection control protocols if needed
Hazard
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Sold states
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.
Affected count
41,526 units
Manufactured in
1266 Kifer Rd, Sunnyvale, CA, United States
Products
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1096-2026More Intuitive Surgical, Inc. recalls
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Cautery Hook instruments recalled for frayed or broken cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Mega Needle Driver recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Grasping Retractor recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S and Si Monopolar Curved Scissors recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S, Si Double Fenestrated Grasper recalled for broken grip cables
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