FDAClass II · Medical device · Recalled May 6, 2026

iLet Bionic Pancreas recall — Beta Bionics, Inc.

Hazard: 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: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1996-2026
Brand: Beta Bionics
Classification: Class II
Units affected: 1,080
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

iLet Bionic Pancreas, REF: BB1001

Affected products

iLet Bionic Pancreas

Companies & origin

Recalling firm location: Irvine, CA, United States
Firm address: 11 Hughes, 92618-1902

Identifying details (verbatim from the notice)

Product codes / lots: Software versions 1.4.3, and 1.4.2
Distribution: US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
FDA event ID: 98475
Recall initiated: March 12, 2026
FDA classified: April 29, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 4:00 AM UTC.

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