FDA recall, , Moderate risk
Beta Bionics iLet Ace Pump Kit and Dosing Decision Software
The iLet Ace Pump Kit and Dosing Decision Software can be bypassed, allowing unauthorized access and potentially causing severe hypoglycemia.
Summary by Recall Canary from the FDA notice
What happened
Beta Bionics, Inc., of Irvine, California, began a recall on August 13, 2025, of the iLet Ace Pump Kit with iLet Dosing Decision Software, after finding 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 include certain icons displayed in the status bar that are active, 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.
The recall was added to the FDA's Enforcement Report on April 10, 2026, and classified on the same date, with distribution nationwide including in states such as Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming and Washington DC.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
- Affected units
- ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming AND WASHINGTON District of Columbia.
- Company
- Beta Bionics, Inc.Irvine, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98528
- Recall number
- Z-1809-2026
- Quantity recalled
- 15 units
All recalls from Beta Bionics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
