Class II — Beta Bionics, Inc.
| Recalling firm | Beta Bionics, Inc. |
|---|---|
| Registered facility | BETA BIONICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software |
| Quantity | 15 units |
| 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. |
| Initiated | 2025-08-13 |
| Classified | 2026-04-10 |
| Recall number | Z-1809-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beta Bionics, Inc. (Z-1809-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98528/
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