iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Class I - DangerousWhat Should You Do?
- Check if you have this product: ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Beta Bionics, Inc.
- Reason for Recall:
- it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Product Codes/Lot Numbers:
ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1809-2026
Related Recalls
iLet Bionic Pancreas, REF: BB1001
Beta Bionics
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.