Beta Bionics recalls
3 official recalls and safety alerts involving Beta Bionics since 2026-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Beta Bionics or the relevant agency.
- 2026-06-24
USBeta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001
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…
FDA · DeviceBeta Bionics, Inc.US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA,…Official notice →- 2026-05-06
- US
Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001
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…
FDA · DeviceBeta Bionics, Inc.US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.Official notice → - 2026-04-22
- US
Beta Bionics, Inc. recalls iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
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,…
FDA · DeviceBeta Bionics, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice →