FreeStyle Libre 2 71952Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 2 Flash Glucose Monitoring System Reader · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Abbott FreeStyle Libre 2 reader is a handheld device used to check glucose levels. Many of the 311 reports describe unexpected high or low glucose alarms, and some mention the reader failing to power up. There were 76 injury reports and no deaths, and 1 open recall from February 2023 covers batteries that may swell or overheat. Reports rose to 19 in the latest 12 months from 10 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 324
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 324 adverse event reports that list this exact device (DI 00357599804008), received between Jan 26, 2021 and Sep 18, 2026 — classified as 76 injuries, 248 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (234 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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-1275-2023 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Product Quality Problem234
- Failure to Power Up33
- Unable to Obtain Readings27
- Device Alarm System19
- Premature Discharge of Battery9
- Device Displays Incorrect Message8
- Battery Problem5
- Power Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions246
- Loss of consciousness39
- Hypoglycemia33
- Hyperglycemia15
- Dizziness11
- Convulsion/Seizure10
- Insufficient Information6
- Diaphoresis5
Recent adverse event reports
The 25 most recent of 324 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830962 ↗MalfunctionSep 17, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812349 ↗MalfunctionSep 16, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789513 ↗MalfunctionSep 8, 2026Product Quality Problem
A customer reported their ADC device is too hot to hold. There was no report of fire, smoke, explosion, or shock. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670452 ↗MalfunctionSep 8, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669289 ↗MalfunctionSep 8, 2026Product Quality Problem
A customer reported their ADC device is too hot to hold. There was no report of fire, smoke, explosion, or shock. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668027 ↗MalfunctionSep 8, 2026Product Quality Problem
A customer reported their ADC device is too hot to hold. There was no report of fire, smoke, explosion, or shock. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50666635 ↗MalfunctionSep 8, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50665717 ↗MalfunctionSep 2, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566597 ↗MalfunctionSep 2, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565754 ↗MalfunctionSep 2, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563218 ↗MalfunctionSep 2, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50562519 ↗MalfunctionSep 2, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50561539 ↗MalfunctionAug 28, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50494544 ↗MalfunctionAug 28, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50492755 ↗MalfunctionAug 27, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. 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 50475695 ↗MalfunctionAug 27, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. 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 50475021 ↗MalfunctionAug 27, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. 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 50473224 ↗MalfunctionAug 26, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453762 ↗MalfunctionAug 26, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450960 ↗MalfunctionAug 26, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. 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 50449928 ↗MalfunctionAug 25, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50429321 ↗MalfunctionAug 18, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. 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 50303532 ↗MalfunctionAug 18, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. 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 50297996 ↗MalfunctionAug 18, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50294340 ↗
Other System, test, blood glucose, over the counter devices
- OneTouch Verio Flex 023-271LifeScan Europe GmbH · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, test, blood glucose, over the counter2 recalls1 death3,286 reports
- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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