Beta Bionics, Inc. recalls iLet Bionic Pancreas

Recalling company

Beta Bionics, Inc.

Product

iLet Bionic Pancreas, REF: BB1001

Reason

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 on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 23, 2025

Reported

Jun 24, 2026

Distribution

US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA, GA, MI, VT, TN, IL, IN, KS, MA, LA, MS, NC, CT, MN, VA, OK, AR, AZ, MO, MT, RI, DC, NM, OR, ID, NV, AK, ND, DE, WV, WY, SD, UT, AL

Status

Ongoing

Quantity

4580

Lot / codes

iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)

Company location

Irvine, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-2513-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2513-2026 in the FDA Enforcement Report. Also see FDA recall press releases.