Company: Beta Bionics, Inc.
Date of Enforcement Report: 4/29/2026
Class: II
PRODUCT:
iLet Bionic Pancreas, REF: BB1001
Recall Number:
Z-1996-2026
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.
RECALLING FIRM/MANUFACTURER:
Beta Bionics, Inc.
VOLUME:
1,080
DISTRIBUTION:
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
