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.
What this means for you
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. The hazard involves potential measurement inaccuracy (drift) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a medical device defect.
Plain-English summary
Cardinal Health 200, LLC is recalling the Genius 2 Tympanic Thermometer (Item Code: 303062). The recall involves 3,619 units distributed 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 remain within the stated accuracy range of ±0.2°C. Over time, measurement readings may drift upwards, causing the device to exceed the upper stated accuracy tolerance of +0.2°C.
Affected products are those manufactured after October 1, 2016, with serial numbers greater than or equal to 16597907. Users should stop using the affected thermometers and contact Cardinal Health for further instructions.
The recalled product
- Product
- Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 3,619
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 or equal 16597907
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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