Cardinal Health Inc.: Medical Device Recall in 2021 - (Recall #: Z-1931-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877

Product Classification:

Class II

Date Initiated: March 16, 2021

Date Posted: June 30, 2021

Recall Number: Z-1931-2021

Event ID: 87787

Reason for Recall:

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

Status: Ongoing

Product Quantity: 2,115 kits

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the states of FL, GA, SC.

Voluntary or Mandated:

Voluntary: Firm initiated