Facility

BETA BIONICS, INC.

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

Key facts

3recalls · worst Class II

1inspections · worst NAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3019004087
Establishment type	Repack or Relabel Medical Device
Location	11 Hughes Irvine, CA, US 92618
Registration status	Active · expires 2026
Parent company	Beta Bionics, Inc. (owner-operator 10088071)
Brand names	iLet Insulin Infusion Kit Inset (32", 6mm); iLet Cartridge Kit; iLet Insulin Infusion Kit Contact Detach (23", 6mm); iLet Insulin Infusion Kit Inset (23", 6mm)

Activity by year

Recalls (3)
Inspections (1)
Warning letters (1)

Devices registered here (1)

Syringe, Piston
Product code FMF (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5860

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…

FDA inspections (1)

NAI2024-10-21
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2026-01-29
Warning Letter (opens in a new tab) · Irvine California

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Beta Bionics, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BETA BIONICS, INC. (FEI 3019004087) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3019004087-beta-bionics-inc/

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