Z-1996-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- March 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,080
Product Description
iLet Bionic Pancreas, REF: BB1001
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.
Distribution Pattern
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Code Information
Software versions 1.4.3, and 1.4.2