FDA DevicesClass II
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Published: April 22, 2026Recall ID: Z-1809-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Additional Source Details
| Field | Value |
|---|---|
| City | Irvine |
| State | CA |
| Event id | 98528 |
| Address 1 | 11 Hughes |
| Address 2 | N/A |
| Code info | ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older. |
| Postal code | 92618-1902 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 15 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250813 |
| Initial firm notification | Letter |
| Center classification date | 20260410 |
Overview
- Recalling FirmBeta Bionics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.