iLet Bionic Pancreas
Beta Bionics is recalling iLet Bionic Pancreas (software 1.4.2–1.4.3) for Dexcom G7 compatibility issues that may disable glucose correction dosing.
Stop using your iLet Bionic Pancreas with Dexcom G7 sensor immediately and contact Beta Bionics for a software update. Do not rely on the device for insulin dosing until the update is installed. Monitor your blood glucose manually and use alternative insulin delivery methods as directed by your healthcare provider.
Why it was recalled
Beta Bionics is recalling iLet Bionic Pancreas devices with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 continuous glucose monitoring sensors that may cause delayed or lost CGM readings. When the device switches to non-CGM dosing mode, it provides only basal and meal doses without correction doses, insulin reductions, or suspensions for high or low blood glucose, potentially resulting in severe hyperglycemia (with or without diabetic ketoacidosis) or severe hypoglycemia.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
iLet Bionic Pancreas, REF: BB1001
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-04-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification