← All recalls
Medical Device

iLet Bionic Pancreas, REF: BB1001

Recall date: 2026-05-06 · Source: FDA_DEVICE
Brand / Firm
Beta Bionics, Inc.
Product
iLet Bionic Pancreas, REF: BB1001
Reason for recall
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.
Units affected
1,080
Description
iLet Bionic Pancreas, REF: BB1001
View official recall notice →