Use caution Medical device recall · FDA · Published September 23, 2025

Beta Bionics iLet ACE Pump Firmware 3.3.6 Recall: Screen Unlock Failure Risk

Beta Bionics recalls iLet ACE Pump firmware version 3.3.6 and earlier due to screen unlock failure causing inability to change insulin cartridges or meal announcements, risking hyperglycemia.

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

🇺🇸 FDA recall #Z-2513-2026Medical device Beta Bionics ›

Use caution until it’s fixed

The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.

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 firmware versions 3.3.4 and 3.3.6 because a screen unlock failure can trap users on the lock screen. This prevents insulin cartridge changes and meal announcements, potentially causing high blood sugar levels if therapy continues without intervention. Read more at govinfonow.com/recall/51243-beta-bionics-ilet-ace-pump-firmware-3-3-6-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/51243-beta-bionics-ilet-ace-pump-firmware-3-3-6-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2513-2026

Cite this page

“Beta Bionics iLet ACE Pump Firmware 3.3.6 Recall: Screen Unlock Failure Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51243-beta-bionics-ilet-ace-pump-firmware-3-3-6-recall. Based on FDA recall #Z-2513-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2513-2026%22&limit=1).

The FDA announced on September 23, 2025, that Beta Bionics, Inc. is voluntarily recalling the iLet Bionic Pancreas due to a firmware issue causing screen unlock failures. This defect prevents users from changing cartridges or announcing meals, potentially leading to hyperglycemia.

How to tell if you have it

Brand: Beta Bionics
Product: iLet Bionic Pancreas, REF: BB1001
Firmware versions: iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)
Units affected: 4580

The hazard

According to the FDA, version 3.3.6 of the iLet ACE Pump firmware and all previous releases contain a screen unlock failure where the user remains on the Lock Screen after sliding the unlock slider. This prevents cartridge changes or meal announcements until the battery drains, which can lead to hyperglycemia if therapy is in progress.

Context

GovInfoNow's records show Beta Bionics, Inc. has two other recalls since August 13, 2025, including a March 12, 2026 recall for delayed glucose readings and an August 13, 2025 recall for unauthorized access risks. Other recent recalls of similar products include the Medtronic MiniMed 780G Insulin Pump Recall regarding software error causing insulin stoppage (May 27, 2026), the Medtronic MiniMed 780G Insulin Pump Recall regarding risk of incorrect insulin delivery (July 13, 2026), and the Fresenius Kabi Ivenix Infusion Pump Recall for touchscreen malfunction after drops (May 6, 2026).

How to tell if you have this one

Check your iLet ACE Pump's firmware version in the device settings. Versions 3.3.4 and 3.3.6 are affected. The recall covers devices sold with these firmware versions.

Brand
Beta Bionics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Firmware Version
Go to the device settings to see the firmware version. If it's 3.3.4 or 3.3.6, it's affected.
Update Firmware
Beta Bionics will provide updated firmware to fix the issue. Contact support for instructions.

Where it went and when

Where it was distributed

Distributed in 50 states and D.C..

FDA distribution: “US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA, GA, MI, VT, TN, IL, IN, KS, MA, LA, MS, NC, CT, MN, VA, OK, AR, AZ, MO, MT, RI, DC, NM, OR, ID, NV, AK, ND, DE, WV, WY, SD, UT, AL” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 9 months after the firm started it.

Sep 23, 2025Firm started the recall
Jun 18, 2026FDA classified it Class II
Jun 24, 2026Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/51243-beta-bionics-ilet-ace-pump-firmware-3-3-6-recall">Beta Bionics iLet ACE Pump Firmware 3.3.6 Recall: Screen Unlock Failure 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-2513-2026 (September 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2513-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.