FreeStyle Libre 3 PlusRecalls & reported problems across all models
Abbott Diabetes Care Inc · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one FreeStyle Libre 3 Plus model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 52,808
- Deaths reported
- 2
- Injuries reported
- 1,601
- Recalls
- 2
We found 5 models of FreeStyle Libre 3 Plus by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 52,808 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2024 and Sep 30, 2026 — classified as 2 deaths, 1,601 injuries, 51,204 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (35,347 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
Reports received per month, all models
FreeStyle Libre 3 Plus 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.
- Nov 24, 2025Open, 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 ↗
- Nov 24, 2025Open, 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 ↗
Most reported FreeStyle Libre 3 Plus problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings35,347
- Low Readings15,195
- Device Alarm System645
- Detachment of Device or Device Component540
- High Readings312
- Adverse Event Without Identified Device or Use Problem252
- Delivered as Unsterile Product205
- Device Displays Incorrect Message201
Patient problems
- No Clinical Signs, Symptoms or Conditions50,829
- Device Embedded In Tissue or Plaque498
- Hypoglycemia393
- Hyperglycemia369
- Loss of consciousness269
- Insufficient Information218
- Skin Infection154
- Dizziness151
FreeStyle Libre 3 Plus models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FreeStyle Libre 3 Plus 78768Integrated Continuous Glucose Monitoring system, factory calibrated1 death33,035 reports
- FreeStyle Libre 3 Plus 78768Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall1 death18,890 reports
- FreeStyle Libre 3 Plus 78769Integrated Continuous Glucose Monitoring system, factory calibrated1 recall472 reports
- FreeStyle Libre 3 Plus 78769-01Integrated Continuous Glucose Monitoring system, factory calibrated367 reports
- FreeStyle Libre 3 Plus 78769Integrated Continuous Glucose Monitoring system, factory calibrated44 reports
Recent FreeStyle Libre 3 Plus 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
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 ↗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 54.00 mg/dL compared to readings of 155.00 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 50947949 ↗
Other Abbott Diabetes Care Inc products
- FreeStyle Libre 314 models · 69,860 reports · 6 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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