FDAClass II · Medical device · Recalled June 24, 2026

iLet Bionic Pancreas recall — Beta Bionics, Inc.

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2513-2026
Brand: Beta Bionics
Classification: Class II
Units affected: 4,580
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

iLet Bionic Pancreas, REF: BB1001

Affected products

iLet Bionic Pancreas

Companies & origin

Recalling firm location: Irvine, CA, United States
Firm address: 11 Hughes, 92618-1902

Identifying details (verbatim from the notice)

Product codes / lots: iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)
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
Firm notified the public via: Letter
FDA event ID: 98517
Recall initiated: September 23, 2025
FDA classified: June 18, 2026
FDA report date: June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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