Beta Bionics recalls iLet Bionic Pancreas software versions 1.4.2 and 1.4.3 due to potential delayed glucose readings causing unsafe insulin dosing. Affected users may experience severe high or low blood sugar levels.
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.
Take action
Contact the company
📍Recalling firmBeta Bionics, Inc.11 Hughes · Irvine, CA 92618-1902
✎ GovInfoNow plain-language explainer
Beta Bionics is recalling specific software versions for their iLet Bionic Pancreas insulin pumps. The software issue can cause delayed glucose readings from Dexcom G7 sensors, which may lead to missing insulin corrections for high or low blood sugar levels. This risk could cause severe hyperglycemia or hypoglycemia. Read more at govinfonow.com/recall/49741-beta-bionics-ilet-bionic-pancreas-software-1-4-2-1.
“Beta Bionics iLet Bionic Pancreas Software 1.4.2/1.4.3 Recall: Delayed Glucose Readings.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49741-beta-bionics-ilet-bionic-pancreas-software-1-4-2-1. Based on FDA recall #Z-1996-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1996-2026%22&limit=1).
The FDA announced on March 12, 2026, that Beta Bionics, Inc. is recalling iLet Bionic Pancreas units due to software issues with Dexcom G7 sensors. The hazard involves delayed readings that may lead to incorrect insulin dosing. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Beta Bionics
Product: iLet Bionic Pancreas
REF: BB1001
Software versions: 1.4.2, 1.4.3
The hazard
The recall involves insulin pump software versions 1.4.2 and 1.4.3 where an issue with the Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM readings. This delay causes the device to switch to non-CGM dosing, providing only basal or requested meal doses without correction doses for high or low glucose levels. Potential health risks include severe hyperglycemia with and without diabetic ketoacidosis (DKA) and severe hypoglycemia.
Context
GovInfoNow's records show Beta Bionics, Inc. has two other recalls on record since August 13, 2025. On September 23, 2025, the company issued a recall for iLet ACE Pump Firmware 3.3.6 due to screen unlock failure risks. On August 13, 2025, Beta Bionics recalled iLet Ace Pump Kit Software versions 1.3.7, 1.4.2, and 1.4.3 for unauthorized access risks. Other recent recalls of similar products include Medtronic MiniMed 780G Insulin Pump Recall (May 27, 2026), Medtronic MiniMed 780G Insulin Pump Software Version 6.60 Recall (November 2, 2025), and Dexcom G7 CGM App: Hypoglycemia Risk Due to Glucose Data Delays (April 14, 2026).
How to tell if you have this one
Check your iLet Bionic Pancreas insulin pump software version. Versions 1.4.2 and 1.4.3 are affected. The recall covers devices sold with these software versions.
Brand
Beta Bionics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Review your iLet Bionic Pancreas software version to see if it is 1.4.2 or 1.4.3.
Update Software
Update to a newer software version if available through Beta Bionics support.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Florida, Georgia, Michigan, Ohio, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA published this recall 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1996-2026 (March 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1996-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.