FDA Medical devices recall ·
iLet Bionic Pancreas recall
- Recall number
- Z-1996-2026
- Date
- (initiated March 12, 2026)
- Company / brand
- Beta Bionics, Inc.
11 Hughes, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,080
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
iLet Bionic Pancreas, REF: BB1001
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software versions 1.4.3, and 1.4.2
Distribution
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
States: Alabama Florida Georgia Michigan Ohio Pennsylvania Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1996-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.