BEUDAMED
    FDA Enforcement Class II Ongoing

    iLet Bionic Pancreas, REF: BB1001

    Recall: Z-1996-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-1996-2026
    Event ID
    98475
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beta Bionics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 6, 2026
    Initiation Date
    March 12, 2026
    Classification Date
    April 29, 2026
    Address
    11 Hughes, Irvine, CA, 92618-1902, United States

    Description

    iLet Bionic Pancreas, REF: BB1001

    Reason

    insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.

    Code Info

    Software versions 1.4.3, and 1.4.2

    Distribution

    US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.

    Quantity

    1,080