FreeStyle Libre 14 dayRecalls & reported problems across all models

We found 5 models of FreeStyle Libre 14 day by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 16,749 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2018 and Sep 30, 2026 — classified as 1 death, 2,933 injuries, 13,815 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (13,244 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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 14 day 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. 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-1274-2023 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

Most reported FreeStyle Libre 14 day problems

FreeStyle Libre 14 day models

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

• FreeStyle Libre 14 day 71940

  Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
  1 death16,002 reports
• FreeStyle Libre 14 day 71938

  Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
  1 recall578 reports
• FreeStyle Libre 14 day 71937

  Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
  1 recall82 reports
• FreeStyle Libre 14 day 71939

  Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
  78 reports
• FreeStyle Libre 14 day 71936

  Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
  1 recall9 reports

Recent FreeStyle Libre 14 day adverse event reports

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

• 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 70.00 mg/dL,80.00 mg/dL compared to readings of 300.00 mg/dL,300.00 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 unknown 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 50943860 ↗
• 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 69 mg/dL compared to readings of 286 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 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 50943574 ↗
• 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 67.00 mg/dL compared to readings of 200.00 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 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 50931834 ↗
• 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 101.00 mg/dL compared to readings of 241.00 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 50929338 ↗
• MalfunctionSep 28, 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 200 mg/dL compared to readings of 100 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 unknown. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913201 ↗
• MalfunctionSep 17, 2026Device Alarm System

  A customer reported a missing high/low glucose alarm with the ADC device. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802353 ↗
• MalfunctionSep 15, 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 500 mg/dL compared to glucose values of 120 mg/dL respectively obtained on the comparison device, 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 50767671 ↗
• MalfunctionSep 14, 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 42 mg/dL compared to glucose values of 240 mg/dL respectively obtained on the comparison device, 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 50750110 ↗
• MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559226 ↗
• MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50558542 ↗
• MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50558516 ↗
• MalfunctionSep 2, 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 182.00 mg/dL compared to glucose values of 86.00 mg/dL respectively obtained on the comparison device, 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 same 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 50558080 ↗
• MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50557997 ↗
• MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50557983 ↗
• MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50557979 ↗

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 212 models · 30,420 reports · 2 recalls
• 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