fda_recall · device_recall · high

Beta Bionics, Inc. — Class II recall: iLet Bionic Pancreas, REF: BB1001

Event date
2026-06-24 00:00:00Z
Observed
2026-07-09 22:52:10Z
Source ID
Z-2513-2026
Payload hash
5a3d11dc64173cf2135c6fc6

Summary

The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen.… Status: Ongoing.

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