Z-1996-2026 Class II Ongoing
FDA device recall Z-1996-2026 was initiated by Beta Bionics, Inc. on Mar 12, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1,080.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- Mar 12, 2026
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1996-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026