Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001

Recall date

March 12, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1996-2026

FDA classification

Class II

Brand / firm

Beta Bionics, Inc.

Sold / distributed

US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.

Why it was recalled

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, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

iLet Bionic Pancreas, REF: BB1001