Class II — Beta Bionics, Inc.
| Recalling firm | Beta Bionics, Inc. |
|---|---|
| Registered facility | BETA BIONICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | iLet Bionic Pancreas, REF: BB1001 |
| Quantity | 1,080 |
| Distribution | US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA. |
| Initiated | 2026-03-12 |
| Classified | 2026-04-29 |
| Recall number | Z-1996-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beta Bionics, Inc. (Z-1996-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98475/
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