The FreeStyle Libre 3 recall & Libre 3 Plus recall involves alleged injuries and deaths. A FreeStyle Libre 3 sensor lawsuit is expected soon. This Glucose Monitor recall, the Libre 3 recall specifically, has the world’s attention right now given the many articles out there right now. The glucose monitor attorney at KBD is on the case.

Faulty Diabetes Glucose Monitors the Freestyle Libre 3 and Freestyle Libre 3 Plus

What We Want Patients to Know and How KBD Attorneys Can Help

The U.S. Food and Drug Administration (FDA) issued a serious alert concerning certain continuous glucose monitors (CGMs) manufactured by Abbott Diabetes Care. This is not an FDA recall. It is an early alert, which FDA sends when “The FDA has become aware of a potentially high-risk issue.”  The issue here concerns the abbott freestyle libre 3, and the freestyle libre 3 plus sensor. 

Some sensors in the FreeStyle Libre 3 and FreeStyle Libre 3 Plus product lines have produced incorrect low-glucose readings. These flawed readings may have contributed to hundreds of serious injuries — and tragically, at least seven deaths worldwide. U.S. Food and Drug Administration FreeStyle Libre 3 alert. 

For individuals living with diabetes — many of whom rely heavily on CGMs to make critical insulin and dietary decisions — these errors are anything but small. That’s why legal accountability may be appropriate for those harmed.

The FreeStyle Libre 3 recall lawyers at KBD are here to help. Email intake@KBDattorneys.com, contact us via this page, or call us at 855- KBD-LAWS Abbott FreeStyle Libre 3 sensor defect causing serious injuries may lead to glucose monitor lawsuit. Learn more now.

What Happened — The FreeStyle Libre 3 Problems in Detail

Hundreds of Injuries and at Least Seven Deaths

The news reports continue to grow. As USA Today reported, there are at least seven deaths associated with this FDA Abbott glucose monitor alert concerning malfunctioning glucose monitors. Over 700 injuries have been reported elsewhere. As CBS News reported, “[t]he model numbers for the affected FreeStyle Libre 3 sensors are 72081-01 and 72080-01, and the unique device identifiers are 00357599818005 and 00357599819002. The model numbers for the affected FreeStyle Libre 3 sensors are 78768-01 and 78769-01, and the unique device identifiers are 00357599844011 and 00357599843014.

How to check if my Libre 3 sensor is affected?

Check the serial number against the list above. The full list of affected lots is available on the FDA’s website.

What Went Wrong

The affected sensors reportedly provided false low glucose readings. Because continuous glucose monitors are often used in lieu of finger-stick blood tests, a misreading could lead a person to incorrectly administer insulin, to skip insulin doses, or to ingest excess carbohydrates. Any of those actions could trigger significant harm — from severe hypoglycemia, hyperglycemia, diabetic ketoacidosis, or worse. See News Channel  According to Abbott and the FDA, about 3 million sensors may be affected, though roughly half may already be expired or used.

What does the FreeStyle Libre 3 recall mean for me?

If you use this product, it could mean you have a legal claim. It depends on whether you had the specific products at issue, and if you suffered an injury because the device failed. Naturally you may ask, can I sue if my CGM sensor was faulty? Contact us now to find out.

Concerns Spark Global Attention

Recent reporting about a potential manufacturing defect in certain sensors for FreeStyle Libre 3 and Libre 3 Plus glucose monitors triggered a worldwide alert. This impacts millions of people relying on these devices to manage diabetes. According to a December 2025 report, approximately three million sensors globally were affected after internal testing found they may deliver incorrectly low glucose readings, potentially leading to dangerous treatment decisions such as skipping insulin or incorrectly dosing sugar. Evrim Ağacı+2U.S. Food and Drug Administration+2

Health authorities and the manufacturer have responded by urging all users of the impacted sensors to stop using them immediately, verify serial numbers via the manufacturer’s recall-portal, and request replacements. Evrim Ağacı+2MedTech Dive+2 For individuals who suffered injuries, complications, or even fatalities tied to these faulty sensors — or who just want to protect their legal rights — it may be critically important to preserve the original packaging and device, and consider contacting legal counsel to explore possible compensation.

What the FDA/Abbott Are Advising Right Now

Users who have a FreeStyle Libre 3 or Libre 3 Plus sensor should immediately check whether their unit is among the affected batches by verifying the serial number. U.S. Food and Drug Administration+1

If a sensor is affected, the recommendation is to stop using it immediately and dispose of it. U.S. Food and Drug Administration+1 As non-medical professionals, we cannot advise you to stop using something and you should not rely on this information on our site; speak to your healthcare provider right away. Abbott is offering free replacement sensors for affected units. U.S. Food and Drug Administration+1 The notice states that until a safe replacement is in hand, patients should rely on a traditional blood-glucose meter or other unaffected methods for treatment decisions — especially when CGM readings don’t match symptoms or expectations. CBS News+1

Again, our advice is to contact a healthcare professional right away, and speak with a product liability law firm, ours or others. Having handled thousands of medical device defect cases, our medical device attorneys are well equipped to help.  

Why This Is Serious — The Health & Legal Stakes

Life-or-Death Risk for People with Diabetes

For many people with Type 1 or Type 2 diabetes, CGMs like Libre 3 are more than convenience — they’re a lifeline. Inaccurate readings aren’t just inconvenient; they can trigger life-threatening decisions. Imagine a CGM says your blood sugar is dangerously low, you skip insulin or ingest sugar, but your actual glucose is high. Or contemplate the vice versa – a false high reading prompts insulin injection, and your real glucose plummets. Both could be catastrophic.

Given the FDA’s notice of serious injuries and deaths tied to these devices, concerns aren’t hypothetical — they’re real and documented. WBAL+1

Legal Risks for Manufacturers & Options for Patients

When a medical device marketed for diabetes management fails — potentially resulting in severe injury or death — the manufacturer may face product liability claims, wrongful-death suits, or negligence actions. That’s where law firms like KBD Attorneys come in.

If you or a loved one experienced harm that may be linked to an affected continuous glucose monitors sensor, (CGM) sensor — especially if you relied on its readings to make treatment decisions — you may have grounds for a case. Possible legal claims could include:

• Defective design or manufacturing

• Failure to warn users of risks

• Negligence

• Other product liability theories

Given the scale (millions of devices) and potential for serious harm — including death — the financial exposure for companies and the compensation potential for harmed patients is substantial.

What Patients (or Families) Should Do Right Now

If you or someone you care about uses a FreeStyle Libre 3 or 3 Plus CGM, follow these steps:

1. Check the sensor serial number at the designated site to see if it’s from an affected batch. U.S. Food and Drug Administration+1

2. If impacted, contact a healthcare provider immediately to determine if you should stop using the sensor immediately. Dispose of it properly. News Channel 3-12+1 Be careful and get instructions from a professional regarding how to remove freestyle libre 3. Even if you are not impacted by the 2024 Freestyle Libre 3 recall or this more recent notice, it is a good reminder to check in with your healthcare provider and brush up on best practices regarding how to use freestyle libre 3. 

3. Consider requesting a free replacement from Abbott. U.S. Food and Drug Administration+1 Be guarded in what you say if you call; any information can be used against you later. 

4. With healthcare provider approval and oversight, switch to a blood-glucose meter or other reliable method for insulin/medication decisions until you have a safe sensor. CBS News+1

5. Monitor for signs of health problems — hypoglycemia, hyperglycemia, unexplained symptoms. Keep detailed records if possible (readings, symptoms, treatment decisions, hospitalizations).

6. Contact an experienced personal injury law firm. You want a firm with product liability attorneys, especially medical device attorney. If you suspect the faulty sensor contributed to health issues.

Act Now to Preserve your Legal Rights – KBD Attorneys is ready to review your case, explain legal rights, and take action if appropriate. Call us at 855-KBD-LAWS.

We are here to help navigate this complex world. KBD actively litigates and tries medical device cases. With experience from prominent, much larger firms, combined with the client-centered focus of a small local firm, we bring exceptional, holistic professional services.

Why This Matters for the Future of Diabetes Care & Medical Device Accountability

This episode underscores several important — and troubling — realities of medical device manufacturing and regulation:

• Even widely adopted, FDA-approved devices can have serious flaws.

• When devices fail, the consequences for patients are immediate and severe — not delayed or hypothetical.

• The path to compensation and accountability often runs through litigation — especially when injury or death is involved.

• Manufacturers must be held responsible for quality control, accurate warnings, and patient safety — not just market share.

For people with chronic diseases who put their trust in medical technology, such failures erode confidence and can have devastating consequences. Legal accountability ensures those trusts are not betrayed without consequence.

How KBD Attorneys Can Help

At KBD Attorneys, we understand how deeply personal — and potentially life-altering — diabetes mismanagement can be. If you or a loved one used a FreeStyle Libre 3 or 3 Plus sensor and suffered serious injury, hospitalization, or worse, after following the device’s readings, you may have legal grounds to hold Abbott accountable.

We offer:

• Free case evaluations to review your medical history, device use, and potential harm.

• Thorough investigation of recall data, manufacturing records, and adverse event reports.

• Proven experience in product-liability and medical device litigation.

• Compassionate support through complex legal and medical issues, while fighting for rightful compensation.

Don’t wait — the sooner you act, the faster evidence can be preserved, and the stronger a case may be.

This is not the First Issue with the FreeStyle Libre 3 – the FreeStyle Libre 3 Recall

There was an FDA recall notice in 2024 about a Continuous Glucose Monitoring (CGM) Sensor Recall due to Risk for Inaccurate High Glucose Readings. It concerned the following specific products:

• Product Name: FreeStyle Libre 3 sensor, a component of FreeStyle Libre 3 Continuous Glucose Monitoring System
• Unique Device Identifier (UDI)/Model:   UDI-DI 00357599818005/ Model No 72081-01
• Lot Numbers:
  • T60001948
  • T60001966
  • T60001969

The FDA issued this urgent safety alert concerning certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitor (CGM) sensors produced by Abbott Diabetes Care Inc., after internal testing identified a potentially deadly defect. The issue was some sensors may deliver incorrect low-glucose readings, misleading users into dangerous treatment decisions. U.S. Food and Drug Administration+1

With approximately 3 million sensors from a single production line implicated, the agency recommended that anyone using a Libre 3 or Libre 3 Plus sensor verify the serial number at the manufacturer’s recall-check site. U.S. Food and Drug Administration+2CBS News+2 The correction does not affect Libre 3 readers, apps, or other Libre products — only the specific sensor lots are under scrutiny, reinforcing how critical it is for patients to check device identifiers before trusting their glucose data. U.S. Food and Drug Administration+1

Final Thoughts

For too many people, continuous glucose monitors have meant greater freedom, better glucose control, and more consistent diabetes management. But when those very devices become dangerously unreliable — leading to serious injury or death — patients deserve accountability.

If you believe a faulty CGM sensor harmed you or someone you care about, you don’t have to face it alone. Contact KBD Attorneys — you have rights, and you deserve justice.