fda_recall · device_recall · high

Beta Bionics, Inc. — Class II recall: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

Event date
2026-04-22 00:00:00Z
Observed
2026-07-09 22:53:03Z
Source ID
Z-1809-2026
Payload hash
365ad600926c05d90e4e6973

Summary

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… Status: Ongoing.

Informational only. Not legal, financial, or medical advice.