Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Medical device recall Z-0251-2020. Published in FDA’s Enforcement Report on Nov 6, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 6, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1,344 Sensors how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
1,344 Sensors, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,997 characters
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 121978 122442 122459 122465 122468 122491 122511 122538 122540 122558 122566 122567 122568 122571 122573 122574 122576 122578 122583 122585 122586 122588 122591 122593 122594 122595 122596 122597 122599 122600 122602 122610 122616 122618 122619 122627 122629 122648 122649 122652 122656 122669 122671 122672 122674 122676 122681 122682 122683 122686 122687 122688 123113 123117 123124 123143 123146 123161 123175 123178 123190 123197 123216 123217 123223 123241 123251 123280 123286 123335 123846 123856 123909 123914 123917 123971 124060 124071 124085 124121 124127 124132 124143 124159 124167 124194 124206 124227 124232 124247 124269 124283 124324 124335 124094 124097 124105 124117 124122 124124 124130 124131 124137 124141 124144 124161 124168 124170 124183 124202 124220 124229 124241 124243 124248 124251 124254 124258 124260 124263 124273 124277 124278 124293 124306 124308 124311 124314 124316 124317 124328 124338 125075 125084 125088 125090 125093 125096 125101 125107 125114 125115 125126 125129 125133 125134 125140 125142 125145 125148 125152 125154 125156 125158 125160 125164 125180 125183 125186 125195…
FDA’s list runs to 5,867 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 18, 2019.
- FDA classified it on Oct 31, 2019.
- FDA’s Enforcement Report published it on Nov 6, 2019.
- FDA terminated it on Jul 30, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Senseonics, Inc., of Germantown, MD.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,867 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.