FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensor Recall Claims

Woman's arm with circular blood sugar monitor on it

Inaccurate CGM Readings Linked to Serious Injuries

If you or a loved one used an Abbott FreeStyle Libre 3 Sensor or FreeStyle Libre 3 Plus Sensor and suffered a severe medical event after inaccurate glucose readings, Ward Black Law may be able to help you pursue a claim.

Abbott has recalled certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors due to reports that some sensors may provide incorrect glucose readings, including readings that are lower than a user’s actual glucose level. The FDA warns that inaccurate readings over an extended period can lead to wrong treatment decisions and serious harm.

What is the FreeStyle Libre 3 system?

The FreeStyle Libre 3 is a continuous glucose monitoring (CGM) system that tracks glucose trends to help people manage diabetes. CGM sensors are prescription medical devices, and accuracy matters because people often make real-time treatment decisions based on sensor readings.

What are the reported “sensor issues”?

According to FDA recall and safety communications, certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide incorrect glucose readings, including readings that are lower than actual blood glucose levels. If the readings are wrong, users may delay insulin, skip insulin, or take other steps that can cause a dangerous medical emergency.

Public reporting has described serious injury reports and deaths associated with the issue, and the FDA has identified a Class I recall for certain affected sensors.

Injuries we are investigating

We are reviewing claims where inaccurate sensor readings may have contributed to severe outcomes, resulting in hospitalization, for any of the following:

  • Diabetic Ketoacidosis
  • Loss of consciousness or coma
  • Seizures
  • Hyperomolar hyperglycemic state
  • Hyperglycemia and/or hypoglycemia
  • Accidents or injuries (falls, vehicle crashes, etc.)
  • Death

Who may qualify?

You may have a potential claim if:

  • You (or your child) have Type 1, Type 2 or Gestational diabetes
  • You were prescribed and used a FreeStyle Libre 3 and were at least 4 years old at the time of use between 2022 and the present
  • FreeStyle Libre 3 Plus system and were at least 2 years old at the time of use between 2022 and the present
  • You experienced inaccurate sensor readings (for example, readings that did not match symptoms or confirmatory testing) that contributed to a serious injury, including hospitalization or worse

Not sure whether your sensor was impacted? Abbott has directed users to check whether their sensors are affected and request replacements.

What to do if you suspect inaccurate readings

Your health comes first:

  • Get medical care immediately if you have symptoms of high or low blood sugar
  • Follow your clinician’s guidance on how to confirm readings and manage your diabetes
  • Save evidence, including sensor packaging, serial or lot information, screenshots from the app, and medical records from the event

We cannot provide medical advice, but we can help you understand your legal options.

How Ward Black Law can help

When medical devices fail, the fallout can be sudden, frightening, and expensive. Our role is to take the legal burden off your plate so you can focus on recovery and your family.

If you contact us, we can:

  • Listen to what happened and confirm basic eligibility
  • Help gather the key records needed to evaluate your case (medical records, device details, timeline of events)
  • Explain potential next steps, including whether your case may fit within broader litigation efforts

Free case review

If you or a loved one suffered a serious injury after using a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor, we invite you to contact Ward Black Law for a free case review.