FDA Recall of FreeStyle Libre 3 Sensors After Reports of Serious Injuries and Deaths

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FDA Warns that Millions of Glucose Monitors May Give Inaccurate Low Readings

A serious safety issue has emerged involving Abbott’s popular FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitors (CGMs). According to a recent FDA safety alert for the FreeStyle Libre glucose sensors, certain lots of these devices may provide dangerously inaccurate low glucose readings, putting users at risk of severe health complications and in some cases, death.

Abbott and the FDA confirmed that nearly 3 million sensors distributed in the United States may be affected by a manufacturing defect. As of early December 2025, there have been 736 severe adverse event reports linked to this issue worldwide, including 7 reported deaths.

What’s the Problem?

The issue involves sensors that may falsely report low glucose levels, also known as hypoglycemia. This can lead users to make incorrect decisions, such as:

• Skipping or reducing insulin doses when they are needed;
• Eating extra carbohydrates to raise blood sugar that is already normal or high;
• Missing true high blood sugar readings (hyperglycemia), which can be dangerous if untreated.

Over time, these incorrect readings may cause serious complications like diabetic ketoacidosis, hospitalization, or long-term damage.

The FDA notes that prolonged reliance on a faulty sensor could result in life-threatening treatment errors.

Which FreeStyle Glucose Sensors Were Recalled

FreeStyle Libre 3 Sensor

• Model number 72081-01
• Model number 72080-01
• Unique Device Identifier (UDI-DI) 00357599818005
• Unique Device Identifier (UDI-DI) 00357599819002

FreeStyle Libre 3 Plus Sensor

• Model number 78768-01
• Model number 78769-01
• Unique Device Identifiers (UDI-DI) 00357599818005
• Unique Device Identifiers (UDI-DI) 00357599819002

How to Find the Serial Number for the FreeStyle Libre Glucose Monitors

You need to know the serial number of your FreeStyle glucose sensor to find out if it’s one of the recalled devices. Here’s how to locate the serial number:

Finding the Serial Number in the App:

• Go to the “About” section in the FreeStyle Libre 3 App
• Look for a titled labeled: “Last 3 Sensors” or “Sensor SN & Status”
• The serial number is listed under that title

Finding the Serial Number on the Packaging:

• Look on the outside of the sensor applicator label
  • The serial number is listed next to the letters “SN.”
  • You may also see a “Lot” number in the same section of the label.
• Look on the bottom of the sensor kit carton
  • The serial number is listed next to the letters “SN.”
    

The FDA Recall and Abbott’s Response

The FDA has issued a formal safety alert, urging all users to:

• Check their sensors to see if they are part of the affected batch.
• Stop using any defective sensors immediately
• Switch to fingerstick blood glucose testing if readings do not match symptoms
• Request a replacement sensor from Abbott at no cost

You can read the entire FDA FreeStyle recall alert here.

Abbott issued what it calls a “medical device correction” on November 24, 2025, affecting specific sensor lots manufactured on one production line. The company says the problem has been corrected and that newer sensors are safe to use.

Despite these steps, the risk to patients who used these sensors before the alert remains significant.

Why You Should Contact a Lawyer about the FreeStyle Recall

If you or someone you know experienced serious health problems while using a FreeStyle Libre 3 or Libre 3 Plus sensor, such as hospitalization, coma, severe hypoglycemia, diabetic ketoacidosis, or other complications, it may be linked to this known defect.

In these situations, it’s important to talk to an attorney who can investigate whether the device played a role in the injury. A lawyer may help:

• Confirm if the sensor you used was part of the affected batch
• Review medical records and sensor data to confirm the device’s role
• Seek compensation for medical expenses, lost income, and pain and suffering
• Hold the manufacturer accountable if their product caused harm

Abbott has already acknowledged the defect and its connection to hundreds of adverse events, but each case is unique. Talking with a lawyer is important to protect your rights if a serious injury or death occurred.

How mctlaw Can Help

mctlaw is a national law firm with experience in medical product liability lawsuits. Our legal team investigates complex device failures and represents individuals hurt by products they trusted to manage their health.

IMPORTANT: We DO NOT file lawsuits against your doctors or medical providers. Our firm only investigates the company that made the defective device. In this case, that company is Abbott.

Your doctor is often one of your best allies if you need to file a lawsuit. We work as partners with your medical providers in any claims against the company for making a defective sensor that impacted your health.

If you or a family member used a FreeStyle Libre 3 or Libre 3 Plus sensor and experienced serious complications, contact mctlaw now for a free case evaluation.

Content Reviewed by Michael Cowgill – Product Liability Lawyer

Michael Cowgill is an experienced attorney in the product liability division at mctlaw. Michael focuses his practice on defective medical devices such as recalled metal-on-metal hips and wrongful death lawsuits involving Kratom. Mr. Cowgill graduated Magna Cum Laude from Lewis & Clark Law School in Portland, OR. He volunteers as a high school mentor with a program for underprivileged youths interested in pursuing a future legal career.

Michael Cowgill’s Attorney Bio

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