FDA-Device2026-01-21Class IIPACKAGING DEFECT
Intuitive Surgical da Vinci SP Access Port Kit recalled for potential sterility breach
What this means
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
The agency's original wording
Hazard
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-07-22Intuitive Surgical da Vinci SP Instrument Arm Drape recalled for detachment risk
- FDA-Device2026-07-01Intuitive Surgical Da Vinci surgical system recalled for E-brake failure risk
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