FreeStyle Freedom LiteRecalls & 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
- Adverse event reports
- 2,436
- Deaths reported
- 0
- Injuries reported
- 82
- Recalls
- 0
We found 5 models of FreeStyle Freedom Lite by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 2,436 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2017 and Sep 30, 2026 — classified as 82 injuries, 2,354 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (2,354 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 Freedom Lite problems
Device problems
- Failure to Power Up2,354
- Incorrect, Inadequate or Imprecise Result or Readings29
- No Device Output22
- Unable to Obtain Readings17
- High Readings7
- Device Displays Incorrect Message5
- Premature Discharge of Battery4
- Product Quality Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions1,507
- No Known Impact Or Consequence To Patient836
- Hypoglycemia31
- Loss of consciousness30
- Hyperglycemia23
- Insufficient Information18
- Dizziness10
- Convulsion/Seizure7
FreeStyle Freedom Lite models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FreeStyle Freedom Lite 70920Glucose dehydrogenase, glucose1,037 reports
- FreeStyle Freedom Lite 70914Glucose dehydrogenase, glucose760 reports
- FreeStyle Freedom Lite 70923-70SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Freedom Lite 71499SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER208 reports
- FreeStyle Freedom Lite 70920SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER53 reports
Recent FreeStyle Freedom 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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949351 ↗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 50943446 ↗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 50943401 ↗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 50943334 ↗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 50942996 ↗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 50928554 ↗MalfunctionSep 21, 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 50839871 ↗MalfunctionSep 21, 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 50837235 ↗MalfunctionSep 21, 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 50836955 ↗MalfunctionAug 31, 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 50516750 ↗MalfunctionAug 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 50493394 ↗MalfunctionAug 28, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50492580 ↗InjuryAug 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
The customer reported erratic readings with the Abbott Diabetes Care (ADC) device. The customer received unspecified erratic sensor scan results. It is unknown whether any symptoms were experienced. The customer was able to eat something provided by a third party. There was no report of death or permanent impairment associated with this event.
Patient problems: Hypoglycemia
MAUDE report 50383837 ↗MalfunctionMay 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 25268792 ↗MalfunctionMay 22, 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 25263254 ↗
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 Lite9 models · 3,388 reports
- FreeStyle Libre 2 Plus4 models · 3,192 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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