RegWardenFDA facility compliance records
Company

Beta Bionics, Inc.

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2025: 2 recalls; 2026: 1 recalls201720182019202020212022202320242202512026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-03-12
    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 reductions/suspension…
  • Class IIOngoing2025-09-23
    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 …
  • Class IIOngoing2025-08-13
    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 ico…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Beta Bionics, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10088071-beta-bionics-inc/

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