- Recalling firm
- Beta Bionics, Inc.
- 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.
- Affected products (lot / model / serial)
- Software versions 1.4.3, and 1.4.2
- Units affected
- 1,080
- Distribution pattern
- US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
- Firm location
- Irvine, CA, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1996-2026
- Recall initiated
- March 12, 2026
- FDA classification date
- April 29, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98475
- Last updated on HTM Vibe
- July 24, 2026