FDA recall, , High risk
Abbott FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
A manufacturing issue may cause carbon build up in the sensor, leading to incorrect low glucose results.
Summary by Recall Canary from the FDA notice
What happened
Abbott Diabetes Care, Inc., of Alameda, California, began a recall on November 24, 2025, for FreeStyle Libre 3 Plus Sensors and FreeStyle Libre 3 Sensors, components of the FreeStyle Libre 3 Continuous Glucose Monitoring System, due to a manufacturing process issue that may cause carbon build up in the sensor, which may result in incorrect low glucose results.
Internal testing determined that some sensors may provide incorrect low glucose readings. The FDA classified the recall on January 13, 2026, and added it to the Enforcement Report on January 14, 2026.
What to do
If a code on your device is listed below:
- If consumers are currently wearing or have a sensor that has been confirmed as potentially impacted on www.FreeStyleCheck.com or by a customer service representative, they should immediately discontinue use and dispose of it.
- Visit www.FreeStyleCheck.com to confirm whether your sensor is potentially affected by this medical device correction.
- Abbott will replace any potentially affected sensors at no charge.
- Detailed instructions on how to check sensors and request a replacement are available on www.FreeStyleCheck.com. Use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to make treatment decisions when sensor readings don’t match symptoms or expectations. To learn more or get help with questions, visit www.FreeStyleCheck.com or call Abbott’s customer service at 1-833-815-4273, available seven days a week from 8 a.m. to 8 p.m. Eastern Time.
Is yours affected?
4 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The
- UDI-DI
- 00357599819002
- Lot code
- T60003166
- T60003169
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The
- UDI-DI
- 00357599843014
- Lot code
- T60003166
- T60003169
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The
- UDI-DI
- 00357599818005
- Lot code
- T60003054
- T60003085
- T60003089
- T60003092
- T60003099
- T60003113
- T60003136
- T60003138
- T60003159
- T60003160
- T60003166
- T60003169
- T60003243
- T60003255
- T60003271
- T60003284
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The
- UDI-DI
- 00357599844011
- Lot code
- T60003138
- T60003243
- T60003255
Recall details
- Company began the recall
- Sold in
U.S.: Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin, West Virginia, and Wyoming. 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.
- Company
- Abbott Diabetes Care, Inc.Alameda, California
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98049
- Recall numbers
- Z-1020-2026 to Z-1023-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall · Announced by the company
Classified by FDA
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
