BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1096-2026 · Initiated December 15, 2025

    Recall

    Recall Number
    Z-1096-2026
    Event Number
    98187
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    December 15, 2025
    Posted
    January 15, 2026
    Address
    1266 Kifer Rd, Sunnyvale, CA, 94086-5304

    Description

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

    Reason

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

    Action

    On December 15, 2025, Intuitive Surgical Inc. issued a Urgent: Medical Device Recall Notification via mail and email. Intuitive asked consignees to take the following actions: 1. Follow the warning provided in the SP Access Port Kit User Manual Addendum 2. Identify Affected Product: Please inspect the product label to confirm the Part Number and Lot Number. 3. If the product label indicates a Lot Number within the affected range specified, proceed with the following actions 4 and 5 below. 4. Quarantine affected inventory: Immediately segregate and quarantine all affected units to prevent clinical use. 5. Return affected product. 6. Forward this notice to all individuals within your organization who need to be aware. 7. Complete the attached Acknowledgement Form immediately and return it to Intuitive via fax or email as instructed on the form. 8. Please retain a copy of this letter, place a copy with your affected system, and keep the acknowledgement form for your files. 9. Please inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems. 10. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Distribution

    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.

    Quantity

    41,526 units