The Recall Desk
HighFDA (Devices)·Z-1931-2021·Announced 2021-06-30

FreeStyle Libre 2 Glucose Monitoring System Recalled for Inaccurate Results

Cardinal Health is recalling FreeStyle Libre 2 glucose monitoring systems shipped between February and March 2021 due to temperature exposure during shipment that may cause inaccurate readings.

What this means for you

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 a Class II FDA medical device recall with no reported illnesses, injuries, or hospitalizations. The hazard—inaccurate glucose readings—is theoretical, falling within the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cardinal Health Inc. is recalling the FreeStyle Libre 2 Glucose Monitoring System (Item number 5658877) following temperature exposure during shipment. The affected devices experienced temperatures of 31.9°F intermittently for approximately 2 hours and 15 minutes, which may cause inaccurate glucose readings.

The recall involves 2,115 kits with all lot numbers shipped from February 23, 2021 through March 10, 2021. Distribution was nationwide, with units specifically identified in Florida, Georgia, and South Carolina. This is a Class II recall, indicating potential for serious adverse health effects.

Patients and healthcare providers who have these devices should contact Cardinal Health for information about replacement or appropriate next steps.

The recalled product

Product
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Manufacturer
Cardinal Health Inc.
Category
Medical Device — Glucose Monitoring System
Hazard
Affected units
2,115

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: 57599080000 All lots numbers shipped from 2/23/201 to 3/10/2021

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

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Same hazard · inaccurate readings

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