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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The FreeStyle Libre 3 Sensor, REF 72081-01, a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System, is being recalled by Abbott Diabetes Care, Inc.
The reason given in the enforcement record is a manufacturing process issue that may cause carbon build up in the sensor, which may result in incorrect low glucose results.
The record lists 1,060,723 sensors carrying UDI-DI 00357599818005, with product expiry date 12/31/2025 and kit lot numbers recorded in the enforcement record. Distribution covered a wide range of US states. The FDA has classified the action as Class I, its most serious category.
Users should follow Abbott's instructions and check with their clinician about confirming glucose readings.
The recalled product
- 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.
- Manufacturer
- Abbott Diabetes Care, Inc.
- Category
- Medical Device — Glucose monitor
- Affected units
- 1,060,723
Distribution
Part of a larger recall action
This product is one of 4 recalled by Abbott Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Abbott Diabetes Care, Inc.
See all →- CriticalLibre 3 Plus sensors recalled in a second lot over carbon build up
FDA (Devices) · 2026-01-21
- CriticalLibre 3 Plus sensors, REF 78769-01, recalled over carbon build up
FDA (Devices) · 2026-01-21
- CriticalLibre 3 Plus sensors recalled over carbon build up causing low readings
FDA (Devices) · 2026-01-21
- SevereFreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings
FDA (Devices) · 2024-09-04
- HighFreeStyle Libre 3 App may lose signal on Android 13 devices
FDA (Devices) · 2024-01-24
Same hazard · incorrect results
See all →- HighSkin cancer aid recalled because it may not meet specifications
FDA (Devices) · 2025-12-03
- HighAlinity hq Analyzer May Generate Incorrect Blood Test Results
FDA (Devices) · 2024-08-28
- HighRX Monaco-IVD Clinical Chemistry Analyzer rerun feature may report incorrect results
FDA (Devices) · 2023-11-08
- HighFDA Recalls ALKP Chemistry Analyzer Slides for Potential Diagnostic Errors
FDA (Devices) · 2023-09-27
Similar recalls
- SevereFreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings
FDA (Devices) · 2024-09-04
- SevereAbbott FreeStyle InsuLinx Blood Glucose Meter Recall for Inaccurate Readings
FDA (Devices) · 2013-05-15
- HighFreeStyle Libre 3 App may lose signal on Android 13 devices
FDA (Devices) · 2024-01-24
- CriticalAbbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results
FDA (Devices) · 2014-03-26
- HighFreeStyle Libre 2 Readers may fail to activate new sensors
FDA (Devices) · 2023-08-23
- SevereAbbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Low Results
FDA (Devices) · 2013-12-25