{"url_path":"/fda/device/recalls/Z-1996-2026","section_key":"summary","section_title":"DEVICE Recall: Beta Bionics, Inc. — iLet Bionic Pancreas, REF: BB1001","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-12","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1996-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Beta Bionics, Inc."},"word_count":123,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1996-2026\n\n**Recalling firm:** Beta Bionics, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-12\n**Report date:** 2026-05-06\n\n## Product\niLet Bionic Pancreas, REF: BB1001\n\n## Reason\ninsulin 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.\n\n## Affected lots\nSoftware versions 1.4.3, and 1.4.2\n\n## Distribution\nUS Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA."}