Quick Facts at a Glance
- Recall Date
- March 12, 2026
- Hazard Level
- HIGH
- Brand
- Beta Bionics
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Beta Bionics
- Model numbers
- Software versions 1.4.3, and 1.4.2
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 12, 2026
Reported by FDA DEVICE
May 6, 2026
RecallRadar source check
May 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beta Bionics, Inc. or your healthcare provider for instructions
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Full Description
iLet Bionic Pancreas, REF: BB1001. Reason: 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.. Classification: Class II. Quantity: 1,080. Distribution: US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
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Safety Guide
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