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

Recalling company

Beta Bionics, Inc.

Product

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 13, 2025

Reported

Apr 22, 2026

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.

Status

Ongoing

Quantity

15 units

Lot / codes

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

Company location

Irvine, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-1809-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1809-2026 in the FDA Enforcement Report. Also see FDA recall press releases.