iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software — Class II medical device recall Z-1809-2026
Ongoing recall by Beta Bionics, Inc., reported 2026-04-22, distributed nationwide. 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 t
| Recall number | Z-1809-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beta Bionics, Inc., Irvine, CA, United States |
| Recall initiated | 2025-08-13 |
| Classified | 2026-04-10 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| Model numbers | BB1001 |
Product
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1809-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.