Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1809-2026 — iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

U.S. FDA — Device Enforcement · United States · 2025-08-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1809-2026
Date of alert
2025-08-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beta Bionics, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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