iLet Bionic Pancreas, REF: BB1001
FDA Recall Z-1996-2026 · Posted 2026-04-29
Recalling FirmBeta Bionics, Inc.
Recall StatusOpen, Classified
Product CodeQFG
Date Initiated2026-03-12
Product Quantity1,080
Reason for Recall
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.
Firm 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 information so the firm can provide the correction notice to these patients.
- Complete the acknowledgment survey https://sprw.io/stt-6HnQU
If you have any questions, please call the firm's Customer Care at 1-855-745-3800 option 1.
Root Cause
Software change control
Distribution Pattern
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.