Warning
Beta Bionics Recalls iLet Bionic Pancreas, REF: BB1001
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1996-2026Medical Device
Beta Bionics Recalls iLet Bionic Pancreas, REF: BB1001
Beta Bionics, Inc. · Class II — Moderate Risk
Product Description
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Beta Bionics, Inc. initiated the recall on March 12, 2026 affecting 1,080. insulin pump software versions 1. 4. 2, and 1. 4. The product was distributed in TX, PA, AL, MI, OH, FL, TN, GA. Consumers should check their purchases and discontinue use of any affected product. Contact Beta Bionics, Inc. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.