iLet Bionic Pancreas recall (Beta Bionics, Inc.)
Medical deviceClass IIOngoing
Summary: Beta Bionics, Inc. is recalling 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.
What is being recalled
iLet Bionic Pancreas, REF: BB1001
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA. (states named: Alabama, Florida, Georgia, Michigan, Ohio, Pennsylvania, Tennessee, Texas)
How to tell if yours is affected
Software versions 1.4.3, and 1.4.2
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1996-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 12, 2026 |
| Reported | May 6, 2026 |
| Company | Beta Bionics, Inc. |
| Company location | Irvine, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,080 |
More recalls from Beta Bionics, Inc. · all medical device recalls · recalls from March 2026