Beta Bionics, Inc. recalls iLet Bionic Pancreas
- Recalling company
- Beta Bionics, Inc.
- Product
- iLet Bionic Pancreas, REF: BB1001
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 12, 2026
- Reported
- May 6, 2026
- Distribution
- US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
- Status
- Ongoing
- Quantity
- 1,080
- Lot / codes
- Software versions 1.4.3, and 1.4.2
- Company location
- Irvine, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1996-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1996-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.