# FDA recall Z-1809-2026

> **Beta Bionics, Inc.** · Class II · device recall initiated 2025-08-13.

## 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.

## 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, VA, WA, WI, WY AND WASHINGTON DC.

## Key facts

- **Recall number:** Z-1809-2026
- **Recalling firm:** Beta Bionics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-13
- **Report date:** 2026-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1809-2026

## Citation

> AI Analytics. FDA recall Z-1809-2026. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1809-2026. Source: US FDA. Licensed CC0.

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