Beta Bionics, Inc.

Beta Bionics, Inc. appears in MedWatcher through reviewed canonical device identities and source-backed FDA or official manufacturer records.

What MedWatcher tracks

This page includes only canonical device families and FDA recall events separately reviewed for publication by MedWatcher. It is not a complete product catalogue.

Reviewed device families: 1
Matched recall actions: 3
Source records last checked: Oct 8, 2026

Manufacturer identity and source matching

Canonical identity is based on the linked official product, UDI, or FDA recalling-firm source. Source-name variants are retained as aliases rather than separate manufacturer pages.

Source databases can use a legal name, brand, division, or shortened name. MedWatcher retains the form used as evidence rather than treating every similar name as the same manufacturer.

Beta Bionics, Inc.Source-name variantReviewed openFDA recalling-firm identity — FUS-265Evidence 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

Page reviewed Aug 17, 2026 by MedWatcher project owner — FUS-265 · Next review by Nov 15, 2026.

Insulin pumps

View category

iLet Bionic Pancreas

Beta Bionics, Inc. · Insulin pumps

No recall records found

Last checked Aug 17, 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 identity and source matching

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 identity and source matching

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