Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:25313
Brand Name:Thermometer, tympanic
Model:Genius 2 Tympanic Thermometer (discontinued) - All product manufactured after October 1, 2016; Serial Numbers ? N16598087, and Genius 3 Tympanic Thermometer - All product manufactured after December 4, 2017; Serial Numbers ? N17700101
Affected:
Software version:
Recalling Organisation:Cardinal Health Australia 503 Pty Ltd
C/o TMF Group
Level 12, 55 Shortland Street
Auckland 1010
Contact Information:
Manufacturer:Covidien LLC
Issue:The manufacturer has identified an issue related to Genius 2 and Genius 3 Tympanic Thermometers. 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.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:30/10/2019
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