12/01/25 (Chicago, IL) – Abbott, one of the largest diabetes tech companies in the world, has recalled approximately 3 million constant glucose monitors (CGMS) from the Freestyle Libre 3 and Freestyle Libre 3 Plus lines due to incorrect low readings. Over time, inaccurate readings could cause users to make misinformed treatment decisions that lead to serious injury or death.
Table of Contents
Not all Freestyle Libre 3 and 3 Plus kits are affected. Abbott has an online serial number checker that will help you determine if your CGM was recalled.
So far, the malfunction has been linked to 736 adverse health events worldwide, including 57 events in the United States. There have also been 7 deaths reported globally, although none occurred in the U.S.
The Dangers of False Low Glucose Readings
False low glucose readings can lead to someone skipping insulin doses or consuming more carbs to raise blood sugar. This can be dangerous, as high glucose levels can be just as deadly as low glucose levels. Diabetes is managed by a careful balancing act, making sure sugars don’t get too low, or too high, and many rely on CGMs to monitor and maintain safe glucose levels.
When a false low is reported, users may not have a secondary device, such as a traditional standard finger-stick glucose meter, to double-check their levels. This can lead to swift treatment to avoid what they believe to be is an oncoming severe low event. Treating a false low can lead to dangerously high blood sugar levels.
When glucose levels rise too high and remain untreated, they can lead to serious complications, including:
- Diabetic Ketoacidosis: This condition occurs when there isn’t enough insulin in your body to move glucose to your cells to be broken down into energy. Without insulin, the body begins breaking down fat for energy, which creates acidic byproducts called ketones. These ketones build up in the blood and spill into the urine. If DKA is not treated promptly, ketoacidosis can lead to a diabetic coma, which can be life-threatening.
- Hyperosmolar Hyperglycemic State: This occurs when your body produces insulin, but cannot use it properly. This can lead to dangerously high glucose levels without ketones. When this condition develops, your body can’t break down glucose or fat for energy, and glucose is instead deposited into the urine. If left untreated, this can lead to life-threatening dehydration and a coma.
Additionally, high glucose levels that are left untreated over time, but are not dangerously high, can lead to complications such as cardiovascular disease, nerve damage, kidney damage, diabetic retinopathy, foot problems, bone and joint problems, and teeth and gum infections.
What Should I Do if My CGM Is Affected By the Recall?
If your CGM device is affected by the Abbott Freestyle Libre 3 recall, it is important that you discontinue use of the device immediately and dispose of it. Do not continue to use it. Always verify suspected severe lows with a finger-stick glucometer to ensure your readings are accurate.
Some variation between glucometer readings and CGM readings is normal, but they should not differ significantly. If your CGM reports a low that is not close to your glucometer’s reading, and your device is not in its warm-up or calibration period, it may be malfunctioning. In that case, rely on your glucometer and compare future readings carefully until the device is replaced.
Can I Claim Damages for a Faulty Medical Device?
If you suffered injuries or lost a loved one due to a faulty medical device, you may be able to recover compensation.
Some damages you may be able to claim include:
- Pain and Suffering
- Loss of Consortium (companionship)
- Emotional Distress
- Medical Expenses
- Lost Wages
- Lost Earning Capacity
- Wrongful Death
In some instances, you may also be able to claim punitive damages if the courts find the manufacturer’s conduct to be especially negligent.
Understanding Product Liability in Medical Device Recalls
When a medical device is recalled, many patients have questions about what their rights are or whether they are eligible to bring a claim. In cases involving recalled CGMs, product liability law allows injured individuals to pursue compensation when a device is defectively designed, improperly manufactured, or sold without adequate warnings. A recall does not automatically prove liability, but it does serve as strong evidence that something was wrong with the product and that the manufacturer was aware of the risk.
To build a successful claim, your legal team may gather medical records, device data, witness statements, and documentation showing how the inaccurate readings affected your health. This may include hospital visits, changes in your medication plan, physical symptoms you experienced, and any long-term complications that developed as a result of the faulty glucose readings.
Families who lost a loved one because of an incorrect CGM reading may also have the right to file a wrongful death claim. These cases can provide compensation for funeral expenses, the loss of financial support, and the emotional impact of losing a family member. An experienced product liability attorney can guide you through the process and help you understand the full scope of compensation available to you.
What if I Can’t Afford an Attorney?
Ankin Law believes that justice should be accessible to everyone. This is why we operate on a contingency fee structure and offer free consultations. You will not pay legal fees unless we win your case. This means you can focus on your recovery instead of worrying about mounting legal expenses.
When you work with Ankin Law, you can expect:
- Personalized, professional legal representation
- 24/7 legal help
- Attorneys who won’t back down
- No legal fees unless we win
Contact us to speak to an experienced product liability attorney today. Call 312 600-0000 for a free consultation.
At Ankin Law, we protect your best interests and work to secure the compensation you need to move forward.
