BEUDAMED
    FDA Enforcement Class II Ongoing

    iLet Bionic Pancreas, REF: BB1001

    Recall: Z-2513-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2513-2026
    Event ID
    98517
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beta Bionics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2026
    Initiation Date
    September 23, 2025
    Classification Date
    June 18, 2026
    Address
    11 Hughes, Irvine, CA, 92618-1902, United States

    Description

    iLet Bionic Pancreas, REF: BB1001

    Reason

    The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.

    Code Info

    iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)

    Distribution

    US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA, GA, MI, VT, TN, IL, IN, KS, MA, LA, MS, NC, CT, MN, VA, OK, AR, AZ, MO, MT, RI, DC, NM, OR, ID, NV, AK, ND, DE, WV, WY, SD, UT, AL

    Quantity

    4580