Beta Bionics, Inc. — iLet Bionic Pancreas, REF: BB1001
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 12, 2026
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
What's affected?
- Product
- iLet Bionic Pancreas, REF: BB1001
- Brand
- Beta Bionics, Inc.
- Lot code
- Software versions 1.4.3, and 1.4.2
Additional details
Software versions 1.4.3, and 1.4.2
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,080.
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