Beta Bionics, Inc.: Alternate Controller Enabled Insulin Infusion Pump
Recall Summary Beta Bionics is recalling iLet Bionic Pancreas insulin pumps with software versions 1.4.2 and 1.4.3 because of a problem with how the pump communicates with Dexcom G7 glucose sensors. When this communication fails, the pump stops delivering correction doses and insulin reductions for high or low blood sugar levels, providing only basic basal insulin and meal doses. This malfunction could lead to dangerously high or low blood sugar levels in users. The recall affects devices distributed nationwide across all U.S. states.
- Recalling firm
- Beta Bionics, Inc.
- Product
- iLet Bionic Pancreas, REF: BB1001
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/57c0fb4f-8642-40f9-951e-b5d746ca21a2