Beta Bionics
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Beta Bionics and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-22FDA-DeviceClass IIUpdate your Beta Bionics iLet Ace Pump immediately
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.
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