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Medical Device

iLet Bionic Pancreas, REF: BB1001

Recall date: 2026-06-24 · Source: FDA_DEVICE
Brand / Firm
Beta Bionics, Inc.
Product
iLet Bionic Pancreas, REF: BB1001
Reason for recall
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. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.
Units affected
4580
Description
iLet Bionic Pancreas, REF: BB1001
View official recall notice →