Use caution Medical device recall · FDA · Published August 13, 2025

Beta Bionics iLet Ace Pump Kit Software Recalls: Unauthorized Access Risk

Beta Bionics recalls iLet Ace Pump Kit software versions 1.3.7, 1.4.2, and 1.4.3 due to potential unauthorized access causing severe hypoglycemia. Affected users should check their software version.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1809-2026Medical device Beta Bionics ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmBeta Bionics, Inc.11 Hughes · Irvine, CA 92618-1902

✎ GovInfoNow plain-language explainer

Beta Bionics is recalling iLet Ace Pump Kit software versions 1.3.7, 1.4.2, and 1.4.3 because a security flaw allows unauthorized access to the device while in Limited Access Mode, which could lead to severe hypoglycemia. This risk affects users who have the specific software versions listed. Read more at govinfonow.com/recall/51615-beta-bionics-ilet-ace-pump-kit-software-recalls-unauthorized-access.

Source Summary by GovInfoNow · govinfonow.com/recall/51615-beta-bionics-ilet-ace-pump-kit-software-recalls-unauthorized-access · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1809-2026

Cite this page

“Beta Bionics iLet Ace Pump Kit Software Recalls: Unauthorized Access Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51615-beta-bionics-ilet-ace-pump-kit-software-recalls-unauthorized-access. Based on FDA recall #Z-1809-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1809-2026%22&limit=1).

The FDA announced on Aug. 13, 2025, that Beta Bionics, Inc. is recalling the iLet Ace Pump Kit (REF: BB1001) due to a software flaw allowing unauthorized access. This vulnerability could lead to severe hypoglycemia if users bypass security screens. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Beta Bionics
Product: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Affected Units: ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older
Quantity: 15 units

The hazard

According to the FDA, versions 1.3.7, 1.4.2, and 1.4.3 of the iLet graphical user interface display active icons on the Lock Screen and Limited Access Passcode Screen status bar. Pressing these icons allows users to bypass security screens, enabling unauthorized access while the device is in Limited Access Mode. The agency states this could result in severe hypoglycemia due to unauthorized meal announcements or stopped insulin delivery.

Context

GovInfoNow's records show Beta Bionics, Inc. has two other recalls on record since Sept. 23, 2025. On March 12, 2026, the company recalled iLet Bionic Pancreas Software 1.4.2/1.4.3 due to delayed glucose readings risk. Other recent recalls of similar products include Medtronic MiniMed 780G Insulin Pump Recall: Software Error Causes Insulin Stoppage (May 27, 2026), Medtronic MiniMed 780G Insulin Pump Recall: Risk of Incorrect Insulin Delivery (July 13, 2026), and Medtronic MiniMed 640G Insulin Pump Recall: Risk of Incorrect Insulin Delivery (July 13, 2026).

How to tell if you have this one

Check your iLet Ace Pump Kit software version. Affected units have software version BOM000036 Rev C (1.4.2) or older. The recall covers iLet Ace Pumps with these specific software versions.

Brand
Beta Bionics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Look for the software version number on your iLet Ace Pump Kit. Affected units have version 1.3.7, 1.4.2, or 1.4.3.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 39 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 8 months after the firm started it.

Aug 13, 2025Firm started the recall
Apr 10, 2026FDA classified it Class II
Apr 22, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to do anything if I have the correct software version?

No action is needed if your software version is newer than 1.4.3.

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Link to this recall

<a href="https://govinfonow.com/recall/51615-beta-bionics-ilet-ace-pump-kit-software-recalls-unauthorized-access">Beta Bionics iLet Ace Pump Kit Software Recalls: Unauthorized Access Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1809-2026 (August 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1809-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.