Reported Apr 22, 2026 · Ongoing
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Beta Bionics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beta Bionics, Inc. · 11 Hughes · Irvine, CA · 92618-1902
Is this the product you have?
- iLet Ace Pump Kit REFBB1001 iLet Dosing Decision Software
- Lot codes and dates
- ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.
- Amount recalled
- 15 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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