Beta Bionics, Inc.

Devices and FDA recall records listed on MedWatcher for Beta Bionics, Inc..

What MedWatcher tracks

This page covers the devices and recall records listed below, not the complete product catalogue or recall history. A recall may apply only to specific models, lots, or serial numbers.

Tracked devices: 1
Recall records: 3
Source records last checked: Oct 27, 2026

Manufacturer names

Device and manufacturer names are linked using official product, UDI, or FDA records. The source links below show the supporting information.

Official records may use a legal name, brand, division, or shortened name. Similar names do not necessarily refer to the same manufacturer.

Beta Bionics, Inc.Source-name variantOfficial source (opens in a new tab)

Sources used for this page

U.S. Food and Drug Administration Global Unique Device Identification DatabaseiLet Starter Kit device identifier recordLast checked Aug 16, 2026 U.S. Food and Drug AdministrationFDA medical device recall event 98475Last checked Aug 16, 2026 U.S. Food and Drug AdministrationFDA medical device recall event 98517Last checked Aug 16, 2026

Insulin pumps

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iLet Bionic Pancreas

Beta Bionics, Inc. · Insulin pumps

No linked recall records

Latest source check Oct 8, 2026

Recent recall records

Class II recallOngoing

iLet Bionic Pancreas recall — FDA event 98517

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,…

FDA · FDA event 98517Posted Jun 18, 2026

Class II recallOngoing

iLet Bionic Pancreas recall — FDA event 98475

insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin…

FDA · FDA event 98475Posted Apr 29, 2026

Class II recallOngoing

iLet Ace Pump Kit recall — FDA event 98528

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…

FDA · FDA event 98528Posted Apr 10, 2026

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Recent recall records

Class II recallOngoing

Beta Bionics, Inc.

Follow Beta Bionics, Inc.

What MedWatcher tracks

Manufacturer names

Sources used for this page

Insulin pumps

iLet Bionic Pancreas

Recent recall records

iLet Bionic Pancreas recall — FDA event 98517

iLet Bionic Pancreas recall — FDA event 98475

iLet Ace Pump Kit recall — FDA event 98528

Beta Bionics, Inc.

Follow Beta Bionics, Inc.

What MedWatcher tracks

Manufacturer names

Sources used for this page

Insulin pumps

iLet Bionic Pancreas

Recent recall records

iLet Bionic Pancreas recall — FDA event 98517

iLet Bionic Pancreas recall — FDA event 98475

iLet Ace Pump Kit recall — FDA event 98528