Official recall record

iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

US FDA — Medical Devices · 2025-08-13 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-08-13
Country of alert: United States
Alert level: Class II
Alert type: recall
Brand on record: Beta Bionics, Inc.

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Other recalls from this brand

2026-03-12 · US FDA — Medical Devices
iLet Bionic Pancreas, REF: BB1001
2025-09-23 · US FDA — Medical Devices
iLet Bionic Pancreas, REF: BB1001

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.