Insulin pump Recall: iLet Ace Kit
Announced 2026-06-24 · FDA
The FDA issued a recall of the Beta Bionics iLet Ace Pump Kit due to a GUI vulnerability in software versions 1.3.7, 1.4.2, and 1.4.3 that allows bypassing Limited Access Mode. If exploited, unauthorized access could lead to altered insulin delivery and severe hypoglycemia. The recall covers 15 units distributed across the US; affected software version BOM000036 Rev C (version 1.4.2) or older.
| Brand | Beta Bionics, Inc. |
|---|---|
| Product | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software |
| Reason | 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. |
| Severity | moderate |
| Units affected | 4580 |
| Distribution | US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MA, MD, ME, MI, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY AND WASHINGTON DC. |
| Agency | FDA |
| Recall / campaign no. | ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older. |
WHAT YOU SHOULD DO
- Check if your device is an iLet Ace Pump Kit with software version BOM000036 Rev C (1.4.2) or older; follow manufacturer guidance and contact Beta Bionics for instructions.
- Do not rely on Limited Access Mode to secure the device; seek guidance from your clinician and the manufacturer for secure usage.
- Monitor recall updates from the FDA and Beta Bionics; arrange for any required replacement or repair per their instructions.
- If you experience symptoms suggestive of hypoglycemia or suspect unauthorized changes to insulin delivery, seek medical help immediately.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.