Beta Bionics, Inc. recalls iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

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.

On March 12, 2026 Beta Bionics issued a Urgent Medical Device Correction - Expansion/Update via Email to notify new consignees and previous consignees. Initial notification was issued on August 13, 2025. Beta Bionics ask consignees to take the following actions: 1. Download or update your iLet app on your phone. Read the iLet App User Guide. 2. Log into your iLet app. 3. Position your iLet next to your phone with the app open. 4. Go to app settings on the iLet app and follow the on-screen instructions to update to the latest firmware. 5. Complete the acknowledgment survey https://sprw.io/stt-6HnQU or scan the QR code. This survey helps us monitor the effectiveness of the recall action.

• FDA enforcement recordOfficial FDA database entry for Z-1809-2026
• FDA 510(k) clearance · K231485The device's official FDA premarket clearance record
• FDA 510(k) clearance · K232224The device's official FDA premarket clearance record
• FDA device classification · QFGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5730The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beta Bionics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.