Abbott Diabetes Care, Inc.: Device Recall

Recall Details

Recall Number

Z-1022-2026

Classification

Class I

Product Type

Device

Recalling Firm

Abbott Diabetes Care, Inc.

Status

Ongoing

Date Initiated

11/24/2025

Location

Alameda, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

258,913 sensors

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

Product Description

FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Distribution Pattern

U.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.

Other Recalls by Abbott Diabetes Care, Inc.

• Class I: Dangerous 11/24/2025
  Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
• Class I: Dangerous 11/24/2025
  Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
• Class I: Dangerous 11/24/2025
  Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
• Class I: Dangerous 07/24/2024
  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 correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.

View all recalls by Abbott Diabetes Care, Inc. →