Fresh Recalls

Beta Bionics recalls

2 recent recalls on record for Beta Bionics in connected official government data as of October 22, 2026 at 6:00 PM UTC.

Models with recalls

iLet Bionic Pancreas (2)

All Beta Bionics recalls

FDA Class II · Medical device · June 24, 2026

iLet Bionic Pancreas recall — Beta Bionics, Inc.

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 successfu…

Official ID Z-2513-2026 · Official record ↗

FDA Class II · Medical device · May 6, 2026

iLet Bionic Pancreas recall — Beta Bionics, Inc.

insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, lea…

Official ID Z-1996-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.