FDA Recall: FreeStyle Libre 3 Glucose Sensors May Show False Low Readings
Immediate action required: Abbott is correcting about 3 million FreeStyle Libre 3 and Libre 3 Plus continuous-glucose-monitoring (CGM) sensors that can display falsely low blood-glucose values. Check your sensor’s serial number at FreeStyleCheck.com and stop using any affected units.
Recall Fast Facts: FreeStyle Libre 3 & Libre 3 Plus
- Manufacturer: Abbott
- Brand: FreeStyle Libre
- Products: Libre 3 and Libre 3 Plus CGM sensors (readers/apps not affected)
- Issue: Incorrect low glucose readings
- U.S. units in scope: ≈3 million (about half already used or expired)
- Adverse reports: 736 serious events worldwide (57 U.S.); 7 deaths (none in U.S.)
- Action timeline: Abbott notice 11/24/2025 • FDA post 01/15/2026
Health Risks of False Low Glucose Readings
When a CGM shows an artificially low value, users may eat unnecessary carbohydrates or withhold insulin, potentially causing dangerous hyperglycemia, diabetic ketoacidosis, or other complications. Prolonged misuse can lead to severe injury and, in rare cases, death.
Step-by-Step Action Plan for FreeStyle Libre 3 Users
- Go to FreeStyleCheck.com and enter the sensor serial number to confirm if it is affected.
- If confirmed, immediately discontinue the sensor and dispose of it properly.
- Request a free replacement through the website or by calling 1-833-815-4273 (8 a.m.–8 p.m. ET, 7 days a week). 24/7 live chat is available at Abbott Support.
- Until a replacement arrives, rely on a traditional blood-glucose meter—or the built-in meter on a Libre 3 reader—if sensor values do not match your symptoms.
Recall Scope & Products NOT Affected
The defect originated from a single manufacturing line making Libre 3 and Libre 3 Plus sensors prior to November 2025. Abbott reports the line has been fixed and anticipates no meaningful supply disruption. The following products are not impacted:
- FreeStyle Libre 14-day, Libre 2, Libre 2 Plus, or Libre Pro sensors
- FreeStyle Libre readers and mobile applications
- All other Abbott biowearables
Abbott Contact Details for Replacement Sensors
- Website: FreeStyleCheck.com
- Phone: 1-833-815-4273 (8 a.m.–8 p.m. ET, daily)
- 24/7 Live Chat: Abbott Support
Frequently Asked Questions
Which FreeStyle Libre 3 sensors are affected by the FDA recall?
The action covers specific FreeStyle Libre 3 and Libre 3 Plus sensors manufactured on one production line before November 2025.
Why is Abbott recalling FreeStyle Libre 3 glucose sensors?
Internal testing and field reports showed some sensors can display falsely low readings, leading to improper diabetes-management decisions.
How do I check my FreeStyle Libre 3 sensor serial number?
Locate the 14-digit serial number on the sensor box or pouch and enter it at FreeStyleCheck.com or call Abbott for assistance.
What steps should I take if my FreeStyle Libre 3 sensor is recalled?
Stop using the sensor, dispose of it safely, and request a free replacement via the website, phone, or live chat.
Are other FreeStyle Libre products impacted by the 2025 recall?
No. FreeStyle Libre 14-day, Libre 2, Libre 2 Plus, Libre Pro sensors, readers, and apps remain safe to use.
Will Abbott replace my recalled FreeStyle Libre 3 sensor for free?
Yes. Abbott will ship a replacement at no cost after verifying your sensor’s serial number and shipping details.
How long will it take to receive a new FreeStyle Libre 3 sensor?
Abbott states most replacement sensors ship within 5–7 business days, although high demand could extend delivery times.