Beta Bionics, Inc. recalls iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

Recall date

August 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1809-2026

FDA classification

Class II

Brand / firm

Beta Bionics, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software