Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1996-2026 — iLet Bionic Pancreas, REF: BB1001

U.S. FDA — Device Enforcement · United States · 2026-03-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1996-2026
Date of alert
2026-03-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beta Bionics, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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