FreeStyle Libre 3Recalls & reported problems across all models

We found 14 models of FreeStyle Libre 3 by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 69,860 adverse event reports in the FDA's MAUDE database, received between Oct 4, 2022 and Sep 30, 2026 — classified as 2 deaths, 2,849 injuries, 67,006 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (45,841 reports).

6 FDA recall records name at least one of these models by its device identifier, 5 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 3 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. Nov 24, 2025Class IOpen, Classified

   Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

   Z-1023-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Nov 24, 2025Class IOpen, Classified

   Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

   Z-1022-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Nov 24, 2025Class IOpen, Classified

   Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

   Z-1021-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Nov 24, 2025Class IOpen, Classified

   Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

   Z-1020-2026 · Root cause: Process control · Recall details · FDA record ↗

5. Jul 24, 2024Class IOpen, Classified

   Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.

   Z-2692-2024 · Root cause: Process design · Recall details · FDA record ↗

6. Feb 9, 2023Class IICompleted

   If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

   Z-0734-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported FreeStyle Libre 3 problems

FreeStyle Libre 3 models

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

• FreeStyle Libre 3 Plus 78768

  Integrated Continuous Glucose Monitoring system, factory calibrated
  1 death33,035 reports
• FreeStyle Libre 3 Plus 78768

  Integrated Continuous Glucose Monitoring System, Factory Calibrated
  1 recall1 death18,890 reports
• FreeStyle Libre 3 72081

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  2 recalls16,326 reports
• FreeStyle Libre 3 Plus 78769

  Integrated Continuous Glucose Monitoring system, factory calibrated
  1 recall472 reports
• FreeStyle Libre 3 Plus 78769-01

  Integrated Continuous Glucose Monitoring system, factory calibrated
  367 reports
• FreeStyle Libre 3 72080

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  1 recall274 reports
• FreeStyle Libre 3 72079

  Integrated Continuous Glucose Monitoring system, factory calibrated
  315 reports
• FreeStyle Libre 3 App 72075-01

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  1 recall23 reports
• FreeStyle Libre 3 72079

  System, test, blood glucose, over the counter
  59 reports
• FreeStyle Libre 3 Plus 78769

  Integrated Continuous Glucose Monitoring system, factory calibrated
  44 reports
• FreeStyle Libre 3 App 72077-01

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  41 reports
• FreeStyle Libre 3 78754

  System, test, blood glucose, over the counter
  11 reports
• FreeStyle Libre 3 78754

  Integrated Continuous Glucose Monitoring system, factory calibrated
  2 reports
• FreeStyle Libre 3 72078

  Integrated Continuous Glucose Monitoring system, factory calibrated
  1 report

Recent FreeStyle Libre 3 adverse event reports

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

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50954721 ↗
• MalfunctionSep 30, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953438 ↗
• MalfunctionSep 30, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953435 ↗
• MalfunctionSep 30, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953434 ↗
• InjurySep 30, 2026Low Readings

  Patient problems: Hyperglycemia

  MAUDE report 50953274 ↗
• InjurySep 30, 2026Unable to Obtain Readings; Device Displays Incorrect Message

  A "replace sensor" error message was reported with the Abbott Diabetes Care (ADC) device and the customer was unable to obtain glucose readings. As a result, the customer experienced hyperglycemia and received IV treatment at urgent care from a healthcare professional for a diagnosis of hyperglycemia. There was no report of death or permanent impairment associated with this event.

  Patient problems: Hyperglycemia

  MAUDE report 50952233 ↗
• 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 54 mg/dL compared to glucose values of 277 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 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 50951475 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951191 ↗
• 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 161.00 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 2 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 50951040 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950455 ↗
• 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 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 the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 9 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 50949358 ↗
• 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 55 mg/dL compared to readings of 161 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 50949354 ↗
• 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 350 mg/dL compared to readings of 130 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 50949352 ↗
• 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 47 mg/dL compared to readings of 277 mg/dL respectively obtained on a meter and the results, when plotted on a Parkes Error Grid, fall into the D 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 50949347 ↗
• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50948714 ↗

Other Abbott Diabetes Care Inc products

• FreeStyle Libre 3 Plus5 models · 52,808 reports · 2 recalls
• FreeStyle Libre 212 models · 30,420 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