Beta Bionics recalls iLet Ace Pump Kit software versions 1.3.7, 1.4.2, and 1.4.3 due to potential unauthorized access causing severe hypoglycemia. Affected users should check their software version.
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.
Beta Bionics is recalling iLet Ace Pump Kit software versions 1.3.7, 1.4.2, and 1.4.3 because a security flaw allows unauthorized access to the device while in Limited Access Mode, which could lead to severe hypoglycemia. This risk affects users who have the specific software versions listed.
The software versions 1.3.7, 1.4.2, and 1.4.3 have a security flaw where pressing certain icons in the status bar allows users to bypass the Lock Screen and Limited Access Passcode Screen. This could let unauthorized people access the device while in Limited Access Mode, potentially causing the user to experience severe hypoglycemia if insulin delivery is interrupted.
People using Beta Bionics iLet Ace Pump Kit with software versions 1.3.7, 1.4.2, or 1.4.3 are most at risk. This includes individuals with diabetes who rely on the pump for insulin delivery.
Check your iLet Ace Pump Kit software version. Affected units have software version BOM000036 Rev C (1.4.2) or older. The recall covers iLet Ace Pumps with these specific software versions.
Look for the software version number on your iLet Ace Pump Kit. Affected units have version 1.3.7, 1.4.2, or 1.4.3.
Software versions 1.3.7, 1.4.2, and 1.4.3 are affected.
Unauthorized access to the device while in Limited Access Mode could cause insulin delivery to stop, leading to severe hypoglycemia.
No action is needed if your software version is newer than 1.4.3.
We’ve drafted a message you can send Beta Bionics to request your refund or repair — edit it as you like.
Subject: Recall Z-1809-2026 — Beta Bionics Beta Bionics Hello, I own a Beta Bionics that is covered by recall Z-1809-2026 from Beta Bionics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
