Beta Bionics, Inc.: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Beta Bionics, Inc.
- Product
- iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-08-13
- Code info
- ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.
- Product quantity
- 15 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Irvine
- State
- CA
- Country
- United States
- Event id
- 98528
Free daily digest + "My products" watchlist