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.
17 Articles
17 Articles
Recall issued for certain glucose sensors due to potentially inaccurate readings, FDA says
A voluntary recall has been issued for certain glucose sensors after reports of inaccurate readings.According to the U.S. Food and Drug Administration, certain FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor devices may show inaccurate readings, posing a potential safety risk to individuals with diabetes.Specifically, the sensors may display incorrect low-glucose readings, leading to incorrect treatment.In December 2025, an Early Aler…
Abbott Diabetes Care Glucose Sensor Recall Designated as ‘Most Serious’
The U.S. Food and Drug Administration (FDA) has classified Abbott Diabetes Care’s November 2025 recall of certain glucose monitoring sensors as the “most serious type” and said that the company had reported 860 cases of serious injuries linked to the devices. Abbott Diabetes Care is a division of Abbott Laboratories. In a Feb. 2 statement, the FDA noted that it is aware of Abbott’s recall and letter to customers, health care providers, and distr…
Diabetes sensors recalled after 7 deaths, hundreds of injuries
Abbott Diabetes Care recalled FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors due to defective readings that show lower glucose levels than actual, the U.S. Food and Drug Administration said. …
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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