FreeStyle Libre 2 71951Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00357599805005), received between Dec 8, 2021 and Sep 17, 2026 — classified as 14 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (49 reports).

2 FDA recall records name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 12, 2023Open, Classified

   If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

   Z-2414-2023 · Root cause: Software Design Change · FDA record ↗

2. 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

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810555 ↗
• MalfunctionSep 2, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563594 ↗
• MalfunctionAug 31, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515783 ↗
• 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 50472456 ↗
• 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 50472255 ↗
• MalfunctionAug 26, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451407 ↗
• MalfunctionAug 26, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50450634 ↗
• MalfunctionAug 25, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50430555 ↗
• MalfunctionAug 18, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50296333 ↗
• MalfunctionAug 17, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276815 ↗
• MalfunctionAug 17, 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 50275772 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438343 ↗
• MalfunctionNov 19, 2024Product Quality Problem; Product Quality Problem

  THE CUSTOMER REPORTS THEIR ABBOTT DIABETES CARE DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. THE CUSTOMER REPORTS THAT THE CHARGING CABLE AND ADAPTER SUPPLIED BY ADC WAS USED WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729748 ↗
• MalfunctionNov 18, 2024Product Quality Problem; Product Quality Problem

  THE CUSTOMER INITIALLY REPORTED THAT THEIR ABBOTT DIABETES CARE DEVICE WAS NOT POWERING ON. THE PRODUCT WAS RETURNED AND INVESTIGATED FOR THE POWER ISSUE, HOWEVER DURING INVESTIGATION INTERNAL BURN MARKS WERE OBSERVED. THIS REPORT IS BEING SUBMITTED DUE TO THE ADDITIONAL ISSUE OBSERVED DURING RETURNED PRODUCT INVESTIGATION. THERE IS NO 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 20713260 ↗
• InjurySep 3, 2024Failure to Power Up; Failure to Power Up

  A BATTERY/NO POWER ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER WAS UNABLE TO TEST DUE TO THE DEVICE NOT POWERING ON WITH BUTTON PRESS OR TEST STRIP INSERTION. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF GLUCOSE TABLETS PROVIDED BY A HEALTHCARE PROFESSIONAL. A READING OF 56 MG/DL WAS OBTAINED FROM UNKNOWN SOURCE, HOWEVER IT IS UNKNOWN WHAT TIME THIS READING WAS OBTAINED IN RELATION TO THE REPORTED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 20128753 ↗
• InjuryJul 31, 2024Break; Break

  THE CUSTOMER REPORTED A BROKEN SCREEN WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. IT WAS INDICATED THAT THE CUSTOMER DROPPED THE METER AND WAS THEREFORE UNABLE TO OBTAIN READINGS. THE CUSTOMER EXPERIENCED DISORIENTATION AND HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO OBTAINED AN UNSPECIFIED BLOOD TEST RESULT AND PROVIDED INSULIN INJECTIONS (DOSE/TYPE UNSPECIFIED) FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Confusion/ Disorientation; Hyperglycemia

  MAUDE report 19876655 ↗
• InjuryJan 30, 2024Premature Discharge of Battery; Failure to Power Up; Premature Discharge of Battery; Failure to Power Up

  A BATTERY/NO POWER ISSUE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER WAS UNABLE TO TEST DUE TO THE DEVICE NOT POWERING ON WITH BUTTON PRESS OR TEST STRIP INSERTION AND AS A RESULT, EXPERIENCED SYMPTOMS REPORTED AS FEELING SICK AND HAVING HEADACHES. AS A RESULT, THE CUSTOMER WAS UNABLE TO SELF-TREAT AND PRESENTED TO THE LOCAL HOSPITAL. UPON ARRIVAL, THE CUSTOMER WAS ADMINISTERED SALINE AND INSULIN INTRAVENOUSLY (2) FOR TREATMENT FOR HYPERGLYCEMIA DIAGNOSIS. NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Headache; Hyperglycemia

  MAUDE report 18606635 ↗
• InjuryJan 25, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A CUSTOMER REPORTED A DISPLAY ISSUE WITH THE ADC DEVICE. THE CUSTOMER OBSERVED "FROZEN" DISPLAY AND WAS UNABLE TO VIEW GLUCOSE READINGS. THE CUSTOMER BECAME HYPOGLYCEMIC AND LOST CONSCIOUSNESS, REQUIRING TREATMENT OF GLUCAGON INJECTION ADMINISTERED BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 18584541 ↗
• InjuryJan 25, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A CUSTOMER REPORTED A DISPLAY ISSUE WITH THE ADC DEVICE. THE CUSTOMER OBSERVED "FROZEN" DISPLAY AND WAS UNABLE TO VIEW GLUCOSE READINGS. THE CUSTOMER BECAME HYPOGLYCEMIC AND LOST CONSCIOUSNESS, REQUIRING TREATMENT OF GLUCAGON INJECTION ADMINISTERED BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 18584538 ↗
• InjuryJan 25, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A CUSTOMER REPORTED A DISPLAY ISSUE WITH THE ADC DEVICE. THE CUSTOMER OBSERVED "FROZEN" DISPLAY AND WAS UNABLE TO VIEW GLUCOSE READINGS. THE CUSTOMER BECAME HYPOGLYCEMIC AND LOST CONSCIOUSNESS, REQUIRING TREATMENT OF GLUCAGON INJECTION ADMINISTERED BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 18584535 ↗
• InjuryDec 19, 2023Failure to Power Up; Failure to Power Up

  A BATTERY/NO POWER ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE READER. CUSTOMER WAS UNABLE TO TEST DUE TO THE READER NOT POWERING ON WITH BUTTON PRESS OR TEST STRIP INSERTION. AS A RESULT, CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPLACED THE CUSTOMER'S READER WITH A BLOOD GLUCOSE TESTING DEVICE AND PROVIDED THIRD-PARTY TREATMENT OF "25 NOVOLOG 70/30." THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 18353761 ↗
• InjuryDec 1, 2023Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

  AN ERROR MESSAGE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER RECEIVED AN ERROR 2 AND ERROR 9 MESSAGES ON THEIR METER DISPLAY AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER WAS ADMINISTERED INSULIN INTRAVENOUSLY BY A HEALTHCARE PROFESSIONAL. A BLOOD GLUCOSE TEST OF 750 MG/DL WAS REPORTED BUT THE CUSTOMER DOES NOT REMEMBER THE DATE OR TIME OF THE TEST. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 18245911 ↗
• MalfunctionNov 9, 2023Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. IT IS UNKNOWN IF THE CUSTOMER'S DEVICE WAS TOO HOT TO HOLD DURING USE OR WHILE CHARGING. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18098330 ↗
• MalfunctionOct 30, 2023Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. IT IS UNKNOWN IF THE CUSTOMER'S DEVICE WAS TOO HOT TO HOLD DURING USE OR WHILE CHARGING. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031039 ↗
• MalfunctionOct 12, 2023Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. IT IS UNKNOWN IF THE CUSTOMER'S DEVICE WAS TOO HOT TO HOLD DURING USE OR WHILE CHARGING. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918386 ↗