Cardinal Health 200, LLC: Medical Device Recall in 2020 - (Recall #: Z-0994-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Genius 2 Tympanic Thermometer Private Label Item Code: 3069

Product Classification:

Class II

Date Initiated: October 28, 2019

Date Posted: February 12, 2020

Recall Number: Z-0994-2020

Event ID: 84202

Reason for Recall:

The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.

Status: Terminated

Product Quantity: in total 37567 units US; 335573 OUS

Code Information:

All product manufactured after October 1, 2016; Serial Numbers greater than N16601357

Distribution Pattern:

Worldwide Distribution - US Nationwide and Foreign in the countries of: Australia Austria Belgium Canada Canary Islands Chile Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana French Polynesia Gabon Germany Gibraltar Greece Guadeloupe Hong Kong Iran, Islamic Republic Of Ireland Israel Italy Kuwait Liechtenstein Luxembourg Martinique Mayotte Mexico Netherlands New Caledonia New Zealand Norway Panama Philippines Poland Portugal Puerto Rico Qatar Reunion Romania San Marino Saudi Arabia Singapore Slovakia Slovenia South Africa South Korea Spain Swaziland Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated