FreeStyle Libre 3 78754 (UDI 00357599842017)Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 3 Continuous Glucose Monitoring System Reader · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00357599842017), received between Jul 13, 2026 and Aug 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Product Quality Problem
The customer initially reported no power with the Abbott Diabetes Care device. The product was returned and investigated for not powering on, however during investigation reader was observed getting hot while charging. This report is being submitted due to the additional issue observed during returned product investigation. There 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 50475131 ↗MalfunctionJul 13, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25792243 ↗
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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- Dexcom G7 GSS (161) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall5 deaths48,180 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.