Home / Recalls / Medical Devices
Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001
Recalled May 6, 2026 · FDA recall Z-1996-2026 · Beta Bionics
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. · FDA Class II
Units
1,080
Sold at
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Description
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.
Product
iLet Bionic Pancreas, REF: BB1001
Manufacturer(s)
Beta Bionics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →