fda_recall · device_recall · high
Beta Bionics, Inc. — Class II recall: iLet Bionic Pancreas, REF: BB1001
- Event date
- 2026-05-06 00:00:00Z
- Observed
- 2026-07-09 22:52:45Z
- Source ID
- Z-1996-2026
- Payload hash
- 7cbc29bef9a7ed90c7e36c09…
Summary
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 gluco… Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.