FREESTYLE LIBRE 14 DAY glucose monitoring system recalled for temperature exposure
Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with risk-of-harm potential. Temperature exposure may cause inaccurate glucose readings, which could affect diabetes management. The source text does not report illnesses, injuries, or hospitalizations, making this a theoretical risk scenario rather than confirmed harm.
Plain-English summary
The FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM (Item Number 5479084, NDC/UPC 57599000101) is being recalled by Cardinal Health Inc. The recall affects 8,959 kits that were shipped between February 23, 2021 and March 10, 2021.
During shipping, the devices were exposed to temperatures of 31.9°F intermittently over a 2 hour and 15 minute period. This temperature excursion may cause the glucose monitoring system to provide inaccurate results, which could affect diabetes management and glucose tracking reliability.
The affected products were distributed nationwide in Florida, Georgia, and South Carolina. Patients who use this glucose monitoring system should consult with their healthcare provider if they have concerns about device accuracy or their blood glucose readings.
Cardinal Health is the recalling manufacturer. Consumers with questions about this recall should contact their healthcare provider or Cardinal Health for guidance on replacement or alternatives.
The recalled product
- Product
- FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
- Manufacturer
- Cardinal Health Inc.
- Affected units
- 8,959
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- NDC/UPC: 57599000101 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution
Part of a larger recall action
This product is one of 14 recalled by Cardinal Health 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 14 products in this recall →Related recalls
Same manufacturer · Cardinal Health Inc.
See all →- HighEnoxaparin syringe bags recalled after being labeled with the wrong strength
FDA (Drugs) · 2025-09-03
- ModerateXolair auto-injectors exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateRecombinate antihemophilic factor vials exposed to temperatures outside labeled storage
FDA (Drugs) · 2025-08-13
- ModerateXolair 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateWegovy injection recalled due to temperature exposure during shipping
FDA (Drugs) · 2025-05-07
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
Similar recalls
- CriticalGlucose monitoring 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
- HighAbbott FreeStyle Precision H Blood Glucose and Ketone Meter Recall
FDA (Devices) · 2020-04-01
- SevereAbbott FreeStyle Blood Glucose Monitors Recalled for Inaccurate Results
FDA (Devices) · 2014-03-26
- CriticalLibre 3 Plus sensors recalled over carbon build up causing low readings
FDA (Devices) · 2026-01-21
- SevereFreeStyle Libre Readers Recalled for Battery Swelling and Fire Hazard
FDA (Devices) · 2023-04-12