iLet Bionic Pancreas: recall status

⚠ Recall found. iLet Bionic Pancreas is named in 2 official recalls in our current data. Details and the official notices are below — act on the remedy in the official notice.

Brand: Beta Bionics

Recalls naming this model

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 ↗

See all Beta Bionics recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & egg products ↗ (not yet aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Compiled from official public-domain CPSC, NHTSA, and FDA data. Sources last checked July 24, 2026 at 1:12 AM UTC.