Abbott Diabetes Care recalls

5 official recalls and safety alerts involving Abbott Diabetes Care since 2023-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Abbott Diabetes Care or the relevant agency.

  1. 2026-01-21
  2. US
    Drugs & medicalClass I

    Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3…

    Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

    FDA · DeviceAbbott Diabetes Care, Inc.U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO,…Official notice →
  3. 2024-09-04
  4. US
    Drugs & medicalClass I

    Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System

    Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus…

    FDA · DeviceAbbott Diabetes Care, Inc.US distribution to states of: NJ, PA, OH, TX, VA, CA, NY, FL, WA, MS, MN, and WYOfficial notice →
  5. 2024-01-24
  6. US
    Drugs & medicalClass II

    Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

    If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which…

    FDA · DeviceAbbott Diabetes Care, Inc.US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX,…Official notice →
  7. 2023-08-23
  8. US
    Drugs & medicalClass II

    Abbott Diabetes Care, Inc. recalls FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

    If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the…

    FDA · DeviceAbbott Diabetes Care, Inc.US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.Official notice →
  9. 2023-04-12
  10. US
    Drugs & medicalClass I

    Abbott Diabetes Care, Inc. recalls FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

    Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked,…

    FDA · DeviceAbbott Diabetes Care, Inc.U.S. Nationwide.Official notice →