Medical Device Recall: iLet Bionic Pancreas, REF: BB1001
Beta Bionics, Inc. · March 12, 2026
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
States Affected
NATIONWIDE
Quantity Affected
1,080
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1996-2026
Status: ongoing
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