iLet Bionic Pancreas recall: Software Issue
iLet Bionic Pancreas, REF: BB1001
Why was iLet Bionic Pancreas 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software versions 1.4.3, and 1.4.2
- Product
- iLet Bionic Pancreas, REF: BB1001
- Recalling firm
- Beta Bionics, Inc.
- Quantity
- 1,080
- Distribution
- US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
- Recall date
- May 6, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)