iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

FDA device recall Z-1809-2026 · posted 2026-04-10 · Open, Classified

Recall details

Recalling firm

Beta Bionics, Inc.

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

QFG

Quantity affected

15 units

Distribution

US 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

Date initiated

2025-08-13

Date posted

2026-04-10

Location

Irvine, CA

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