FreeStyle Libre Sensors: Risks, Recalls & Safety Concerns
FreeStyle Libre sensors are wearable continuous glucose monitoring (CGM) devices that measure glucose and send frequent readings to a compatible reader or smart device. Libre 3 and Libre 3 Plus sensors have been recalled for incorrect readings that have caused injuries and deaths.
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What Is the FreeStyle Libre Sensor?
The FreeStyle Libre sensor, manufactured by Abbott, is a disposable, coin‑sized sensor worn on the back of the upper arm that continuously measures glucose in the interstitial fluid under the skin and stores or transmits readings for review.
FreeStyle Libre systems are intended for people with diabetes who need frequent glucose monitoring, including many with Type 1 or insulin‑treated Type 2 diabetes. The Libre 3 Plus sensors are made for use in young children and adults.
| System Name | Sensor Types | Typical Wear Duration | Key Features | Indicated Users/Age |
|---|---|---|---|---|
| FreeStyle Libre 2 System | Libre 2 and Libre 2 Plus sensors | Up to 14 days for Libre 2; up to 15 days for Libre 2 Plus | Real‑time readings, optional high/low alarms, smartphone or reader use | Libre 2 and Libre 2 Plus: Adults and children ages 2 to 1 |
| FreeStyle Libre 3 System | Libre 3 and Libre 3 Plus sensors | Up to 14 days for Libre 3; up to 15 days for Libre 3 Plus | Smaller profile sensor, real‑time continuous streaming to phone, optional alerts | Libre 3: Adults and children ages 4 and up Libre 3 Plus: Adults and children ages 2 and up |
| Libre / Libre 14‑day Systems | Libre (10‑day) and Libre 14‑day sensors | Up to 10 or 14 days, depending on the version | “Flash” scanning with a reader or phone to see stored values | Libre and Libre 14-day: Adults with Type 1 and insulin-dependent Type 2 diabetes, and children with Type 1 diabetes |
The FreeStyle Libre Flash Monitoring system, approved by the FDA in 2017, was the first FDA-approved CGM that didn’t require finger stick testing.
Since then, Abbott has released the newest FreeStyle Libre CGM sensors: Libre 2 Plus and Libre 3 Plus. It will be discontinuing Libre 2 and Libre 3.
How FreeStyle Libre 3 Plus Works
FreeStyle Libre 3 and Libre 3 Plus are next‑generation CGM systems that provide continuous, real‑time glucose readings without routine fingersticks, using a small sensor and a linked app or reader.
The Libre 3 and Libre 3 Plus sensors are applied to the back of the upper arm, where a tiny filament just under the skin measures interstitial glucose levels. Each sensor continuously samples glucose and transmits readings every minute, allowing users and clinicians to see time‑in‑range, trends and patterns over the sensor wear period.
The Libre 3 Plus sensor offers extended wear (up to 15 days). It is designed for broader pump connectivity and younger pediatric use compared with the standard Libre 3 sensor. Both sensor types are part of integrated systems that include software tools and optional alerts to support day‑to‑day diabetes management.
Benefits and Limitations of FreeStyle Libre Sensors
FreeStyle Libre sensors (including Libre 3) measure interstitial glucose every minute and display trends, arrows and summaries. This helps users and clinicians adjust insulin, food and activity. Real‑world and clinical data show that Libre use can lower hypoglycemia time and DKA rates, along with producing modest A1C reductions in many patients.
However, Libre systems have limitations. Sensor accuracy can be affected by vitamin C levels, the first 12 hours of wearing a new sensor and storing the sensor kit below 36 degrees or above 82 degrees Fahrenheit.
People can also experience skin reactions, sensor signal loss and other potential technical issues.
FreeStyle Libre 3 Features Compared With Traditional Meters
The biggest difference between traditional blood glucose meters (BGMs) and the FreeStyle Libre 3 and Libre 3 Plus is that BGMs require you to prick your finger for a blood sample, place the sample on a fingerstick and insert it into a BGM to get glucose readings.
The Freestyle Libre uses a sensor that’s on your arm and doesn’t require fingersticks. The FreeStyle Libre 3 also provides continuous glucose monitoring. In addition, BGMs measure blood glucose, while FreeStyle Libre 3 measures glucose in the fluid between cells, called interstitial fluid. Because glucose hits the blood more quickly, there will be a lag when measuring glucose in interstitial fluid.
Health Risks and Injuries Linked to FreeStyle Libre Sensors
FreeStyle Libre sensors are linked to mostly mild skin and insertion‑site reactions. However, inaccurate readings, lost signals and recent Libre 3 and 3 Plus defects have been associated with dangerous highs or lows and, in rare cases, severe injury or death.
- Bleeding or bruising at the sensor site
- False high readings with Libre 2 and 3 when you take over 500 mg of Vitamin C a day
- False high readings with Libre 2 Plus and 3 Plus when taking over 1,000 mg of Vitamin C a day
- False readings
- Sensitivity to sensor adhesive can cause significant skin irritation
- Sensor can break in the body, requiring a visit to a health care professional
- Sensor can loosen due to sweat or movement
- Sensor may loosen or fall off before the end of wear time
- Sensor signal loss
When Libre readings are wrong or unavailable, users can inadvertently over- or undertreat their glucose, leading to hypoglycemia or hyperglycemia.
In serious cases, this may even be fatal.
FreeStyle Libre 3 Recalls and FDA Safety Warnings
FreeStyle Libre 3 and 3 Plus sensors have been the subject of FDA safety alerts and global recalls because certain lots can give dangerously incorrect glucose readings, especially falsely low results.
In July 2024, Abbott issued a recall of a small number of FreeStyle Libre 3 Sensors due to incorrect high glucose readings.
Then, in November 2025, the FDA released an Early Alert for Libre 3 and Libre 3 Plus because they were providing incorrect low glucose readings. This action involves about 3 million devices in the U.S. Abbott reported 736 serious injuries and seven deaths linked to this problem worldwide.
Devices and Serial Numbers in the 2025 Early Alert
| FreeStyle Libre 3 Sensor | FreeStyle Libre 3 Plus Sensor |
|---|---|
| Model number 72081-01 | Model number 78768-01 |
| Model number 72080-01 | Model number 78769-01 |
| Unique Device Identifier (UDI-DI) 00357599818005 | Unique Device Identifier (UDI-DI) 00357599844011 |
| Unique Device Identifier (UDI-DI) 00357599819002 | Unique Device Identifier (UDI-DI) 00357599843014 |
Concerned people with more questions about this issue can also contact Abbott Diabetes Care via their website.
Potential Injuries From Recalled Libre 3 and Libre 3 Plus Sensors
Recalled Libre 3 and Libre 3 Plus defects have been linked to hundreds of serious injuries and at least seven deaths worldwide. When CGMs provide faulty readings that cause undetected dangerous lows or highs, complications such as DKA, seizures, coma and death can occur.
- Diabetic Ketoacidosis (DKA) and Severe Hyperglycemia:
- Falsely low sensor readings may cause patients to underdose or delay insulin, allowing glucose to rise for hours or days. This can cause DKA, especially in people with Type 1 diabetes.
- Severe Hypoglycemia:
- Falsely high readings can push people to administer extra insulin, resulting in profound hypoglycemia. Hypoglycemia can cause confusion, falls and seizures, which could lead to car accidents. It can also cause coma and death. The recall information also included the risk of neurological damage, central nervous system dysfunction and loss of consciousness.
- Death:
- FDA’s 2025 alert states that at least seven deaths have been linked to incorrect Libre 3 and 3 Plus readings from the defective sensors.
These injuries typically occur when users trust sensor values that don’t match their symptoms, adjust insulin or carbohydrates accordingly, and don’t have adequate backup testing or medical oversight to catch the error in time.
How To Check FreeStyle Libre 3 Recall Serial Numbers
Patients can check their app or the device package for FreeStyle Libre 3 serial numbers. The FDA has provided step-by-step instructions in its Early Alert announcement, and you can also check Abbott’s Urgent Medical Device Correction site.
- In the FreeStyle Libre 3 app, select “About Screen” from the Main Menu. Locate the sensor serial number under “Last 3 Sensors.”
- In the Libre app, go to the bottom Menu, select Profile, then go to About. Locate the sensor serial number under “Last 3 Sensors.”
- In the FreeStyle Libre 3 Reader, go to Settings Menu and select “System Status,” then “System Info.”
Legal and Safety Concerns Involving FreeStyle Libre Sensors
Following the 2024 recall and 2025 medical device correction, lawyers have raised legal and safety concerns that Abbott knew about the sensor defects but concealed them from the public.
Lawyers are investigating FreeStyle Libre 3 and Libre 3 Plus lawsuits on behalf of people injured by these products.
How Abbott Has Responded to FreeStyle Libre 3 Safety Concerns
Abbott announced a voluntary medical device correction for certain Libre 3 sensors in 2024 due to incorrect high readings. They then issued a global recall in November 2025 of select Libre 3 and 3 Plus lots after they identified a manufacturing issue that caused incorrect low readings.
The FDA continues to work with Abbott on the latest medical device correction in November 2025. The company voluntarily reported 736 serious injuries and seven deaths related to the issue and coordinated with the FDA to provide information to the public.
As part of the recall and medical device corrections, Abbott has offered free replacements through the FreeStyleCheck.com portal.
What To Do if You Have a FreeStyle Libre Sensor Problem
If your FreeStyle Libre 3 or 3 Plus sensor is flagged as part of the recall or medical device correction, you should stop using it immediately and get a replacement or use an alternative recommended by your diabetes care team.
- Stop using the affected sensor, and switch to a backup blood glucose meter or another non‑affected CGM if available.
- Request a replacement from Abbott by submitting serial numbers and contact details through the recall website. Distributors confirm that replacements and shipping are provided at no cost.
- Use backup testing and monitor symptoms. Patients should rely on fingerstick blood glucose checks and treat symptoms — not just device readings — if they feel signs of high or low blood sugar. Any mismatch between symptoms and sensor values warrants immediate fingerstick confirmation and medical advice.
Contact your diabetes care team to manage your glucose while off the affected sensor, adjust insulin safely and arrange follow‑up care if you experience unstable readings or acute events.
Report injuries or malfunctions with the FDA’s MedWatch.
Talking With a Lawyer if a FreeStyle Libre Problem Caused Serious Harm
If you or a loved one has been seriously harmed by a defective FreeStyle Libre 3 or Libre 3 Plus sensor, you may choose to file a lawsuit for potential compensation.
FreeStyle Libre Sensor FAQs
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