FDA Device recall Z-1809-2026
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
- FDA Device
- Class II
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class II recall of iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software by Beta Bionics, citing 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 displaye….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1809-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-13 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Beta Bionics |
| Distribution | US |
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.
Identifiers
| code_info | ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1809-2026%22
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