Beta Bionics recalls
2 federal recalls 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.
- 2026-06-24FDA-DeviceClass IIBeta Bionics iLet Bionic Pancreas recalled for screen lock failure
A firmware bug in the iLet Bionic Pancreas can cause the lock screen to fail to unlock when users slide the unlock slider. When this happens, users become stuck on the lock screen and cannot change insulin cartridges or enter meal information. The pump will continue delivering insulin until the cartridge empties and the battery drains, which may lead to high blood sugar.
- 2026-04-22FDA-DeviceClass IIUpdate your Beta Bionics iLet Ace Pump immediately
Certain versions of the iLet Ace Pump software (1.3.7, 1.4.2, and 1.4.3) have a security flaw that allows someone to bypass the Lock Screen and Limited Access Passcode Screen by pressing icons in the status bar. This could let an unauthorized person make false meal announcements or stop insulin delivery, risking severe low blood sugar.
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