Recall Z-2513-2026 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Beta Bionics, Inc.
iLet Bionic Pancreas, REF: BB1001
| Date | Jun 18, 2026 (initiated Sep 23, 2025) |
| Status | Open, Classified |
| 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 anno |
| Root cause | Software design |
| Action | On 3/12/2026, recall notices were mailed and emailed to customers who were informed of the following: On September 23, 2025, Beta Bionics, Inc. issued an Urgent Medical Device Correction notification to customers informing them of the lock screen software issue and software upgrade. These problems are resolved in newer host software versions (3.3.7 and up). Please check your software version and update your software as soon as possible. Update your software 1. Download or update your iLet app on your phone. Need help! Read the iLet App User Guide. 2. Log into your iLet app. 3. Position your |
| Quantity | 4580 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K252770 | iLet ACE Pump Beta Bionics, Inc., Sep 29, 2025 |