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Medical Device

iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

Recall date: 2026-04-22 · Source: FDA_DEVICE
Brand / Firm
Beta Bionics, Inc.
Product
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Reason for recall
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.
Units affected
15 units
Description
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
View official recall notice →