Recall Z-1996-2026 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Beta Bionics, Inc.
iLet Bionic Pancreas, REF: BB1001
| Date | Apr 29, 2026 (initiated Mar 12, 2026) |
| Status | Open, Classified |
| Reason | 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/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia. |
| Root cause | Software change control |
| Action | On 3/12/2026, correction notices were emailed to customers who were asked to do the following: Update device software to host software 1.4.4 and up. Update your software 1. Download or update your iLet app on your phone. Read the iLet App User Guide: https://www.betabionics.com/wp-content/uploads/LA000056_F-iLet-Mobile-App-User-Guide.pdf 2. Log into your iLet app. 3. Position your iLet next to your phone with the app open. 4. Go to app settings on the iLet app and follow the on-screen instructions to update to the latest firmware. -Distributors are asked to provide patient contact informat |
| Quantity | 1,080 |
| Distribution | US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K252770 | iLet ACE Pump Beta Bionics, Inc., Sep 29, 2025 |