BEUDAMED
    FDA Enforcement Class II Ongoing

    iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

    Recall: Z-1809-2026 · Reported April 22, 2026

    Enforcement

    Recall Number
    Z-1809-2026
    Event ID
    98528
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beta Bionics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2026
    Initiation Date
    August 13, 2025
    Classification Date
    April 10, 2026
    Address
    11 Hughes, N/A, Irvine, CA, 92618-1902, United States

    Description

    iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

    Reason

    it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.

    Code Info

    ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.

    Distribution

    US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MA, MD, ME, MI, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY AND WASHINGTON DC.

    Quantity

    15 units