FreeStyle Libre 2Recalls & reported problems across all models

We found 12 models of FreeStyle Libre 2 by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 30,420 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2020 and Sep 30, 2026 — classified as 2 deaths, 5,600 injuries, 24,818 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (19,887 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

FreeStyle Libre 2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 12, 2023Open, Classified

   If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

   Z-2414-2023 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗

2. Feb 13, 2023Open, Classified

   Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.

   Z-1275-2023 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

Most reported FreeStyle Libre 2 problems

FreeStyle Libre 2 models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FreeStyle Libre 2 71992

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  1 death23,063 reports
• FreeStyle Libre 2 71953

  System, test, blood glucose, over the counter
  2 recalls1 death3,286 reports
• FreeStyle Libre 2 Plus 78747

  Integrated Continuous Glucose Monitoring system, factory calibrated
  1,833 reports
• FreeStyle Libre 2 Plus 78747

  Integrated Continuous Glucose Monitoring system, factory calibrated
  1,337 reports
• FreeStyle Libre 2 72000

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  453 reports
• FreeStyle Libre 2 71952

  System, test, blood glucose, over the counter
  1 recall324 reports
• FreeStyle Libre 2 71951

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  2 recalls72 reports
• FreeStyle Libre 2 App 71926-01

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  21 reports
• FreeStyle Libre 2 Plus 78749

  Integrated Continuous Glucose Monitoring system, factory calibrated
  17 reports
• FreeStyle Libre 2 71953

  System, Test, Blood Glucose, Over The Counter
  6 reports
• FreeStyle Libre 2 Plus 78749

  Integrated Continuous Glucose Monitoring system, factory calibrated
  5 reports
• FreeStyle Libre 2 App 71857-01

  System, test, blood glucose, over the counter
  3 reports

Recent FreeStyle Libre 2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50955132 ↗
• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50953814 ↗
• InjurySep 30, 2026Unable to Obtain Readings; Device Displays Incorrect Message

  Patient problems: Hypoglycemia

  MAUDE report 50953813 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 46 mg/dL compared to readings of 249 mg/dL respectively obtained on a meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 1 day. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949349 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 53 mg/dL compared to readings of 200 mg/dL respectively obtained on a Meter and the results, when plotted on a Parkes Error Grid, fall into C Zone, showing difference in values to be clinically significant. The length of sensor wear was 4 days. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946446 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 50.00 mg/dL compared to readings of 210.00 mg/dL respectively obtained on a Meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 7 days. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944676 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 66.00 mg/dL,68.00 mg/dL compared to readings of 172.00 mg/dL,202.00 mg/dL respectively obtained on a Meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 8 days. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944671 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 103.00 mg/dL compared to readings of 249.00 mg/dL respectively obtained on a Meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 5 days. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944336 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 64.00 mg/dL compared to readings of 172.00 mg/dL respectively obtained on a meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 7 days. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943968 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943513 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 50.00 mg/dL and 58.00 mg/dL compared to readings of 258.00 mg/dL and 240.00 mg/dL respectively obtained on a meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 3 days. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935928 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 57 mg/dL compared to readings of 220 mg/dL respectively obtained on a meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 7 days. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931744 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 50 mg/dL and 53 mg/dL compared to readings of 177 mg/dL and 107 mg/dL respectively obtained on a meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 1 day. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931740 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930492 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 53 mg/dL compared to readings of 162 mg/dL respectively obtained on a meter and the results, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 10 days. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929666 ↗

Other Abbott Diabetes Care Inc products

• FreeStyle Libre 314 models · 69,860 reports · 6 recalls
• FreeStyle Libre 3 Plus5 models · 52,808 reports · 2 recalls
• FreeStyle Libre 14 day5 models · 16,749 reports · 1 recall
• FreeStyle Lite9 models · 3,388 reports
• FreeStyle Libre 2 Plus4 models · 3,192 reports
• FreeStyle Freedom Lite5 models · 2,436 reports
• FreeStyle Libre7 models · 705 reports · 1 recall
• Precision Xtra10 models · 391 reports