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U.S. Department of Health and Human Services

Medical Device Recalls
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 Medical Device Recallssee related information
Date Initiated by FirmNovember 24, 2025
Create DateJanuary 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1023-2026
Recall Event ID 98049
ProductFreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information ContactLindsy Delco
224-280-2475
Manufacturer Reason
for Recall		Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
ActionOn 11/24/2025, the firm communicated "Urgent Medical Device Correction" letter to customers and Healthcare Providers that Abbott has recently identified that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. We learned about this through our ongoing product monitoring, where Libre 3 and Libre 3 Plus sensor users reported situations where they received incorrect low glucose readings. Customers are instructed: -If you are currently wearing or have a FreeStyle Libre 3 / FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affected on www.FreeStyleCheck.com or by a customer service representative, immediately discontinue use and dispose of the affected sensor(s). You can request a replacement for any potentially affected sensor(s) on www.FreeStyleCheck.com. Select CONFIRM SENSOR SERIAL NUMBER and enter a valid serial number. If your sensor is potentially impacted, you will be instructed to enter your contact information so a replacement product can be sent to you at no cost. -Use a blood glucose meter or the built-in meter in your FreeStyle Libre 3 Reader to make treatment decisions when your sensor readings don t match your symptoms or expectations. -If you are wearing a FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor, you can find the serial number in the app or reader. The serial number can also be found on the label on the bottom of the sensor applicator or carton. (If you are using a sensor with a connected insulin delivery device, please refer to the connected insulin delivery device user manual on how to locate the sensor serial number.) For questions/to report any adverse reactions/quality problems experienced, call Abbott Customer Service at 1-833-815-4273, available seven days a week from 8 a.m. to 8 p.m. Eastern Time. Agents are available 24/7 through live chat at https://www.freestyle.abbott/us-en/support/contact-us.html.
Quantity in Commerce8,062 sensors
DistributionU.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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