FreeStyle Libre 2 71953 (UDI 00357599803018)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00357599803018), received between Jun 17, 2026 and Sep 22, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K193371); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Product 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858266 ↗
• MalfunctionSep 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 50804283 ↗
• MalfunctionSep 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 50798473 ↗
• MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Customer reported receiving a low reading from their Abbott Diabetes Care device. Customer reported a low reading of 108.00 mg/dL which was lower than a meter reading of 248.00 mg/dL . The results when plotted on a Parkes Error Grid fell into the "C" zone showing the difference in values to be clinically significant. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752843 ↗
• MalfunctionJul 1, 2026Product Quality Problem

  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. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25683499 ↗
• MalfunctionJun 17, 2026Product Quality Problem

  A CUSTOMER REPORTS THEIR ABBOTT DIABETES CARE DEVICE, "GET'S HOT, CAUSING CALLER TO UNPLUG IT." NO OTHER DETAILS WERE PROVIDED. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR ELECTRIC 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535166 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193371. One submission often covers many models, so check the product and lot details in each record.

• Z-2414-2023 · Jul 12, 2023 · Open, Classified
  FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
• Z-1275-2023 · Feb 13, 2023 · Open, Classified
  FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
• Z-1931-2021 · Mar 16, 2021 · Open, Classified
  FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877