Official recall record

iLet Bionic Pancreas, REF: BB1001 (ref Z-2513-2026)

US FDA — Medical Devices · 2025-09-23 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-09-23
Country of alert: United States
Alert level: Class II
Alert type: recall
Brand on record: Beta Bionics, Inc.

What the authority reported

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.

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 2026-09-16.

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
2025-08-13 · US FDA — Medical Devices
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

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.