FreeStyle Libre 3 72078Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 3 Continuous Glucose Monitoring System Reader · Class 2
All models of FreeStyle Libre 3 (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00357599821012), received between Apr 9, 2026 and Apr 9, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Low Readings” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K223435, K233537); 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.
Reports received per month
Most reported problems
Device problems
- Low Readings1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2026Low Readings
A LOW GLUCOSE READING ISSUE WAS REPORTED WITH THE USE OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER RECEIVED AN UNSPECIFIED LOW GLUCOSE READING WITH THE ADC DEVICE AND IT IS UNKNOWN WHETHER THE CUSTOMER NOTED A TREND ARROW ON THE DEVICE. THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO ADC PRODUCT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 24835616 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223435, K233537. One submission often covers many models, so check the product and lot details in each record.
- Z-1022-2026 · Nov 24, 2025 · Open, ClassifiedFreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring Syst
- Z-1021-2026 · Nov 24, 2025 · Open, ClassifiedFreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring Syst
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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 14, 2026 · each report above links to its original FDA record
- 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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