BEUDAMED
    FDA Recall Open, Classified

    iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

    Recall: Z-1809-2026 · Initiated August 13, 2025

    Recall

    Recall Number
    Z-1809-2026
    Event Number
    98528
    Firm
    Beta Bionics, Inc.
    FEI Number
    3019004087
    Product Code
    QFG
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    August 13, 2025
    Posted
    April 10, 2026
    Address
    11 Hughes, Irvine, CA, 92618-1902

    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.

    Action

    On March 12, 2026 Beta Bionics issued a Urgent Medical Device Correction - Expansion/Update via Email to notify new consignees and previous consignees. Initial notification was issued on August 13, 2025. Beta Bionics ask consignees to take the following actions: 1. Download or update your iLet app on your phone. Read the iLet App User Guide. 2. Log into your iLet app. 3. Position your iLet next to your phone with the app open. 4. Go to app settings on the iLet app and follow the on-screen instructions to update to the latest firmware. 5. Complete the acknowledgment survey https://sprw.io/stt-6HnQU or scan the QR code. This survey helps us monitor the effectiveness of the recall action.

    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