FreeStyle LiteRecalls & reported problems across all models
Abbott Diabetes Care Inc · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,388
- Deaths reported
- 0
- Injuries reported
- 264
- Recalls
- 0
We found 9 models of FreeStyle Lite by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 3,388 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Sep 30, 2026 — classified as 264 injuries, 3,124 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (2,814 reports).
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
Most reported FreeStyle Lite problems
Device problems
- Failure to Power Up2,814
- Incorrect, Inadequate or Imprecise Result or Readings369
- High Readings51
- No Device Output50
- Device Displays Incorrect Message38
- Unable to Obtain Readings35
- Low Readings31
- Battery Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions1,692
- No Known Impact Or Consequence To Patient1,360
- Hyperglycemia113
- Loss of consciousness83
- Hypoglycemia78
- Dizziness51
- Insufficient Information40
- No Consequences Or Impact To Patient35
FreeStyle Lite models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FreeStyle Lite 70805Glucose dehydrogenase, glucose2,366 reports
- FreeStyle Lite 70829-70SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70827Glucose dehydrogenase, glucose234 reports
- FreeStyle Lite 70804SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER129 reports
- FreeStyle Lite 71026SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER105 reports
- FreeStyle Lite 70822SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER92 reports
- FreeStyle Lite 70804SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER82 reports
- FreeStyle Lite 70817Glucose dehydrogenase, glucose1 report
- FreeStyle Lite 70819Glucose dehydrogenase, glucose1 report
Recent FreeStyle Lite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947248 ↗MalfunctionSep 30, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944887 ↗MalfunctionSep 30, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943512 ↗MalfunctionSep 30, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943444 ↗MalfunctionSep 30, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942985 ↗MalfunctionSep 29, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934330 ↗MalfunctionSep 29, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933847 ↗MalfunctionSep 29, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932746 ↗MalfunctionSep 29, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928536 ↗MalfunctionSep 29, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928533 ↗MalfunctionSep 28, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913714 ↗MalfunctionSep 28, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912857 ↗MalfunctionSep 28, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911116 ↗MalfunctionSep 25, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898797 ↗MalfunctionSep 24, 2026Failure to Power Up
The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884252 ↗
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 Libre 14 day5 models · 16,749 reports · 1 recall
- 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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