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.
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.
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.
The firmware versions 3.3.4 and 3.3.6 have a bug where sliding the unlock slider doesn't transition to the screen. Users get stuck on the lock screen and can't change insulin cartridges or set meal announcements. This can cause high blood sugar levels if the pump continues delivering insulin without proper adjustments.
People using Beta Bionics iLet ACE Pumps with firmware versions 3.3.4 or 3.3.6 are affected. Those with diabetes who rely on the pump for insulin delivery are at risk of hyperglycemia if the screen issue occurs.
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.
Go to the device settings to see the firmware version. If it's 3.3.4 or 3.3.6, it's affected.
Beta Bionics will provide updated firmware to fix the issue. Contact support for instructions.
The recall is due to a screen unlock failure in firmware versions 3.3.4 and 3.3.6 that prevents users from changing insulin cartridges or setting meal announcements.
Users get stuck on the lock screen and can't change insulin cartridges or set meal announcements, which may lead to high blood sugar levels if therapy continues without intervention.
Check your iLet ACE Pump's firmware version in the device settings. Versions 3.3.4 and 3.3.6 are affected.
We’ve drafted a message you can send Beta Bionics to request your refund or repair — edit it as you like.
Subject: Recall Z-2513-2026 — Beta Bionics Beta Bionics Hello, I own a Beta Bionics that is covered by recall Z-2513-2026 from Beta Bionics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
