Beta Bionics, Inc. is recalling 15 iLet Ace Pump Kits containing software version 1.4.2 or older. A software flaw in versions 1.3.7, 1.4.2, and 1.4.3 allows the device's lock screen and passcode security to be bypassed by pressing certain icons in the status bar. This vulnerability could lead to unauthorized access to the device settings while it is in Limited Access Mode. If an unauthorized user makes meal announcements or stops insulin delivery, it can lead to dangerous health outcomes. No injuries or incidents have been reported to date.
The software defect allows unauthorized users to bypass security screens and change insulin dosing settings. This poses a high risk of severe hypoglycemia (dangerously low blood sugar) if insulin delivery is stopped or if incorrect meal information is entered without the owner's knowledge.
Affected software includes version BOM000036 Rev C (version 1.4.2) or older, specifically affecting GUI versions 1.3.7, 1.4.2, and 1.4.3.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.