Archive · 5 Dec 2025
FDA Warns of Faulty Glucose Monitors Linked to Deaths
The FDA is warning people to stop using certain glucose monitors made by Abbott Diabetes Care.
These monitors, called FreeStyle Libre 3 and FreeStyle Libre 3 Plus, might give wrong readings that can be dangerous for people with diabetes.
The FDA says these wrong readings could lead to bad decisions about treatment, like eating too many carbs or skipping insulin, which can be very harmful.
About 3 million of these monitors in the U.S. are affected, and there have been 7 deaths and over 700 injuries worldwide.
No deaths happened in the U.S., but there were 57 injuries.
Abbott has fixed the problem in the affected batch and is telling customers to check if their monitors are safe and get replacements if needed.
People can check their monitors on a special website and get new ones if theirs are affected.
The FDA warns against using certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitors due to incorrect low glucose readings.
Incorrect readings may lead to harmful treatment decisions, posing serious health risks, including potential injury or death.
About 3 million sensors in the U.S. are affected, with 7 deaths and 736 serious adverse events reported worldwide.
No deaths occurred in the U.S., but 57 injuries were reported.
Abbott has identified and resolved the issue in the affected production lot and is notifying customers to check and replace affected sensors.
- Who
- U.S. Food and Drug Administration (FDA) and Abbott Diabetes Care
- What
- Warning about faulty glucose monitors linked to deaths and injuries
- When
- Issued this week (specific date not mentioned)
- Where
- United States
- Why
- Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide incorrect low glucose readings, leading to serious health risks
- Company
- Abbott Diabetes Care
- Affected Products
- FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors
- Number of Affected Sensors
- About 3 million in the U.S.
- Reported Deaths
- 7 worldwide, 0 in the U.S.
- Reported Injuries
- 736 worldwide, 57 in the U.S.
- Model Numbers Affected
- 72080-01, 78768-01, 78769-01
- Unique Device Identifiers
- 00357599818005, 00357599819002, 00357599844011, 00357599843014
- Website for Check
- www.FreeStyleCheck.com