Reported Nov 6, 2019 · Terminated

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

Senseonics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Senseonics, Inc. · 20451 Seneca Meadows Pkwy · Germantown, MD · 20876-7005

Is this the product you have?

  • Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Lot codes and dates
  • Serial Numbers

    836 of 836 codes

    • 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
Amount recalled
1,344 Sensors

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 30, 2020 · Data as of Sep 19, 4:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.