iLet Bionic Pancreas, REF: BB1001
Published May 6, 2026 · Recall initiated: March 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Beta Bionics, Inc.
- Distributor
- US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
- Lot
- Software versions 1.4.3, and 1.4.2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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