Abbott Recalls Diabetes Glucose Sensors Due to Serious Injuries

FDA designates recall as 'most serious' as number of reported injuries reaches 860

Feb. 4, 2026 at 9:31pm

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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.

Why it matters

This recall highlights the critical importance of medical device safety, especially for products used by those managing chronic conditions like diabetes. The high number of reported injuries raises concerns about the quality control and oversight processes for these types of essential healthcare products.

The details

Abbott Diabetes Care, a division of Abbott Laboratories, issued the recall in November 2025 for specific models of its FreeStyle Libre 2 and FreeStyle Libre 3 glucose monitoring sensors. The FDA has now designated this as a 'Class I' recall, the most serious type, indicating a reasonable probability that use of the devices could cause serious injury or death.

  • Abbott Diabetes Care issued the recall in November 2025.

The players

Abbott Diabetes Care

A division of Abbott Laboratories that manufactures glucose monitoring devices for people with diabetes.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of medical devices in the United States.

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The takeaway

This recall underscores the critical need for rigorous quality control and safety testing of medical devices, especially those relied upon by vulnerable populations like those managing diabetes. It serves as a reminder that even established companies must remain vigilant to protect patient health and safety.