Class II — Senseonics, Inc.
| Recalling firm | Senseonics, Inc. |
|---|---|
| Registered facility | Senseonics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface |
| Product | Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor |
| Quantity | 1,344 Sensors |
| Distribution | Nationwide |
| Initiated | 2019-09-18 |
| Classified | 2019-10-31 |
| Terminated | 2020-07-30 |
| Recall number | Z-0251-2020 |
| 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 — Senseonics, Inc. (Z-0251-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83896/
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