Cardinal Health Genius 2 Tympanic Thermometer Recall for Accuracy Drift
Cardinal Health is recalling Genius 2 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential accuracy drift in a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health 200, LLC is recalling the Genius 2 Tympanic Thermometer (Private Label, Item Code: 3069). The recall involves units manufactured after October 1, 2016, with serial numbers greater than N16601357. The distribution was worldwide, including the United States and numerous foreign countries.
The recall was initiated because the calibration frequency stated in the operating manual may not ensure that the thermometers always remain within the stated accuracy range of ± 0.2°C. The measurement readings are reported to drift upwards over time, which means the thermometers could exceed the upper stated accuracy tolerance of +0.2°C.
Consumers and healthcare providers should stop using the affected thermometers and follow the instructions provided by Cardinal Health for replacement or repair.
The recalled product
- Product
- Genius 2 Tympanic Thermometer Private Label Item Code: 3069
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
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 (3)
- All product manufactured after October 1
- 2016
- Serial Numbers greater than N16601357
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Cardinal Health 200, LLC 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.
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