# FDA recall Z-0251-2020

> **Senseonics, Inc.** · Class II · device recall initiated 2019-09-18.

## Product

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

## Reason for recall

Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0251-2020
- **Recalling firm:** Senseonics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-18
- **Report date:** 2019-11-06
- **Termination date:** 2020-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Germantown, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0251-2020

## Citation

> AI Analytics. FDA recall Z-0251-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0251-2020. Source: US FDA. Licensed CC0.

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