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
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 to identify it
iLet Bionic Pancreas, REF: BB1001
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-04-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification