BEUDAMED
    FDA Enforcement Class I Ongoing

    Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

    Recall: Z-1855-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-1855-2026
    Event ID
    98525
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2026
    Initiation Date
    March 11, 2026
    Classification Date
    May 1, 2026
    Address
    1266 Kifer Rd, Sunnyvale, CA, 94086-5304, United States

    Description

    Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

    Reason

    Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

    Code Info

    UDI:00886874121931/All serial Numbers

    Distribution

    US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin OUS: Austria Belgium Denmark Finland France Germany Ireland Italy Japan Netherlands Norway Spain Sweden Switzerland United Kingdom