Beta Bionics iLet Bionic Pancreas
The iLet Bionic Pancreas software may delay CGM readings, leading to severe hyperglycemia or hypoglycemia.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Beta Bionics, Inc., of Irvine, California, recalled the iLet Bionic Pancreas, REF: BB1001, because insulin pump software versions 1.4.2 and 1.4.3 have an issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensors that may delay CGM readings and then switch to non-CGM dosing, providing only basal and requested meal doses without correction doses or insulin reductions for high or low glucose unless blood glucose is entered.
The recall began March 12, 2026, and was added to the FDA's Enforcement Report on April 29, 2026, with distribution in Alabama, Florida, Georgia, Michigan, Ohio, Pennsylvania, Tennessee, and Texas.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the reference number, then check the FDA notice for any lot or serial restrictions.
iLet Bionic Pancreas
- Reference number
- BB1001
- Affected units
- Software versions 1.4.3, and 1.4.2
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Texas, Pennsylvania, Alabama, Michigan, Ohio, Florida, Tennessee, Georgia.
- Event ID
- 98475
- Recall No.
- Z-1996-2026
- Company
- Beta Bionics, Inc.Irvine, California
- Hazard
- Software defect
- Recall type
- Voluntary: Firm initiated
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
