FDA DevicesClass II
iLet Bionic Pancreas, REF: BB1001
Published: May 6, 2026Recall ID: Z-1996-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
iLet Bionic Pancreas, REF: BB1001
Additional Source Details
| Field | Value |
|---|---|
| City | Irvine |
| State | CA |
| Event id | 98475 |
| Address 1 | 11 Hughes |
| Code info | Software versions 1.4.3, and 1.4.2 |
| Postal code | 92618-1902 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 1,080 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260312 |
| Center classification date | 20260429 |
Overview
- Recalling FirmBeta Bionics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.