FDA Device recall Z-0251-2020
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor by Senseonics, citing eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0251-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-18 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Senseonics |
| Distribution | US |
Product
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Reason
Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface
Identifiers
| code_info | Serial Numbers: 102622 102634 102650 102658 102730 102748 102752 102769 102782 102784 102791 101037 101050…Serial Numbers: 102622 102634 102650 102658 102730 102748 102752 102769 102782 102784 102791 101037 101050 101057 101076 101095 101116 101118 101121 101140 101155 101170 101171 101175 101189 101190 101194 101204 101232 101244 101245 102618 102726 102757 106287 106298 106304 106342 106355 106391 106438 106461 106470 106475 106495 106501 106514 106519 106534 106291 106331 106337 106356 106380 106385 106410 106413 106456 106480 106506 106528 105795 105804 105815 105821 105831 105837 105844 105848 105863 105864 105873 105928 105942 105988 120828 120847 120891 120909 120922 121061 121065 121071 121072 121102 121114 121117 121139 121150 121167 121183 121193 121202 121216 121217 121219 121242 121275 121279 121288 121299 121324 121329 121342 121354 121373 121386 121392 121393 121398 121434 121440 121449 121451 121473 121496 121820 121843 121847 121864 121867 121950 121974 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0251-2020%22
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