The Recall Desk

Manufacturer

Abbott Diabetes Care, Inc.

18 recalls in our database name Abbott Diabetes Care, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
18
Critical
5
Severe
5
Most recent
2026-01-21

Of the 18 recalls from Abbott Diabetes Care, Inc. we have scored against our rubric, 5 (28%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (28%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–18 of 18

  • CriticalFDA (Devices)·Z-1022-2026·2026-01-21

    Libre 3 Plus sensors, REF 78769-01, recalled over carbon build up

    Abbott Diabetes Care is recalling 258,913 FreeStyle Libre 3 Plus sensors, REF 78769-01, because carbon build up in the sensor may result in incorrect low glucose results.

    Product
    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.
    Category
    Medical Device
    Distribution
    36 states
  • CriticalFDA (Devices)·Z-1021-2026·2026-01-21

    Libre 3 Plus sensors recalled in a second lot over carbon build up

    Abbott Diabetes Care is recalling 1,663,241 FreeStyle Libre 3 Plus sensors, REF 78768-01, because carbon build up in the sensor may result in incorrect low glucose results.

    Product
    FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
    Category
    Medical Device
    Distribution
    36 states
  • CriticalFDA (Devices)·Z-1020-2026·2026-01-21

    Glucose monitoring sensors recalled over carbon build up causing low readings

    Abbott Diabetes Care is recalling 1,060,723 FreeStyle Libre 3 sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.

    Product
    FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
    Category
    Medical Device
    Distribution
    36 states
  • CriticalFDA (Devices)·Z-1023-2026·2026-01-21

    Libre 3 Plus sensors recalled over carbon build up causing low readings

    Abbott Diabetes Care is recalling 8,062 FreeStyle Libre 3 Plus sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.

    Product
    FreeStyle 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.
    Category
    Medical Device
    Distribution
    36 states
  • SevereFDA (Devices)·Z-2692-2024·2024-09-04

    FreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings

    FreeStyle Libre 3 sensors may report falsely high glucose levels, causing users to over-dose insulin and miss dangerous low blood sugar episodes. Abbott has recalled 8,174 units.

    Product
    FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0734-2024·2024-01-24

    FreeStyle Libre 3 App may lose signal on Android 13 devices

    Abbott is recalling FreeStyle Libre 3 App on Android 13 devices due to signal loss that may prevent users from receiving glucose readings and alarms, potentially delaying necessary treatment.

    Product
    FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2414-2023·2023-08-23

    FreeStyle Libre 2 Readers may fail to activate new sensors

    FreeStyle Libre 2 Readers may display an 'Incompatible Sensor' error when attempting to activate a new sensor after incomplete 14-day wear, potentially preventing new sensor activation and causing delayed glucose monitoring.

    Product
    FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1275-2023·2023-04-12

    FreeStyle Libre Reader batteries pose fire and swelling hazard

    FreeStyle Libre Reader batteries used in glucose monitoring systems may swell, overheat, or pose a fire hazard. Users should only charge with the included cable and discontinue use if devices show damage, excessive heat, or charging problems.

    Product
    FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1274-2023·2023-04-12

    FreeStyle Libre Readers Recalled for Battery Swelling and Fire Hazard

    Abbott is recalling over 1.3 million FreeStyle Libre Readers nationwide due to lithium-ion battery swelling, overheating, and fire hazards. Users should stop use if devices show damage, swelling, or excessive heat.

    Product
    FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1273-2023·2023-04-12

    FreeStyle Libre Readers recalled due to lithium-ion battery fire hazard

    FreeStyle Libre Reader batteries may swell, overheat, or create fire hazard. Do not use if the device is damaged, cracked, swollen, excessively hot, won't hold charge, or fails Reader Test.

    Product
    FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2020·2020-04-01

    Abbott FreeStyle Precision H Blood Glucose and Ketone Meter Recall

    Abbott is recalling FreeStyle Precision H meters because unapproved instructions for disinfection and multi-patient use may lead to infection.

    Product
    FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1556-2020·2020-04-01

    Abbott Precision Xtra Blood Glucose Meters Recalled for Uncleared Disinfection Instructions

    Abbott is recalling Precision Xtra Blood Glucose & Ketone Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA and could lead to infection.

    Product
    Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
    Category
    Medical Device
    Distribution
    32 states
  • CriticalFDA (Devices)·Z-1212-2014·2014-03-26

    Abbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors because they may produce inaccurate low blood glucose readings when used with specific test strips.

    Product
    FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2014·2014-03-26

    Abbott FreeStyle Blood Glucose Monitors Recalled for Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Blood Glucose Monitors because they may produce inaccurate blood glucose readings when used with specific test strips.

    Product
    FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2014·2013-12-25

    Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Results

    Abbott Diabetes Care is recalling specific lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.

    Product
    FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2014·2013-12-25

    Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Low Results

    Abbott Diabetes Care is recalling certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.

    Product
    FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Dia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1245-2013·2013-05-15

    Abbott FreeStyle InsuLinx Blood Glucose Meter Recall for Inaccurate Readings

    Abbott is recalling FreeStyle InsuLinx meters because they may provide inaccurate readings at rare, extremely high glucose levels (1024 mg/dL and above).

    Product
    FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Abbott Diabetes Care

business enterprise in United States of America

Country
United States

Source: Wikidata (Q45135103), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.