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US FDA Says Injuries From Abbott's Recalled Glucose Sensors Reach 860

The FDA recorded 860 serious injuries and seven deaths linked to faulty FreeStyle Libre 3 sensors that can give incorrect glucose readings, risking patient safety.

  • On January 14, the U.S. Food and Drug Administration elevated the recall of some FreeStyle Libre 3 and Libre 3 Plus sensors by Abbott Diabetes Care to a Class I, the agency said.
  • Abbott said some FreeStyle Libre 3 sensors produced sustained incorrect low glucose readings linked to the affected production line, and it identified and resolved the cause.
  • Company data show 860 serious injuries and seven deaths as of Jan. 7, 2026, while FreeStyle Libre 3 readers and mobile apps are not impacted by the recall.
  • Patients and people living with diabetes should check serial numbers at www.freestylecheck.com, discontinue affected sensors, and request free replacements; device distributors and wholesalers must retrieve recalled units via normal return procedures.
  • The FDA updated guidance yesterday warning that continued use may cause serious injury or death and Abbott Diabetes Care sent affected customers a letter on Nov. 24, 2025.
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FDA: Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors recalled after seven deaths, 860 injuries

The Food and Drug Administration (FDA) has now identified the recall of certain FreeStyle Libre glucose monitor sensors as “most serious" and is warning that using the recalled device may cause serious injury or death if you continue to use it.

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Reuters broke the news in United Kingdom on Wednesday, February 4, 2026.
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