Cardinal Health Recalls Genius 2 Tympanic Thermometers for Accuracy Drift
Cardinal Health is recalling Genius 2 Tympanic Thermometers because calibration frequency may not ensure readings stay within 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. The hazard involves potential measurement inaccuracy (drift) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a medical device with a theoretical risk of harm.
Plain-English summary
Cardinal Health 200, LLC is recalling the Genius 2 Tympanic Thermometer (Item Code: 303000). The recall affects units manufactured after October 1, 2016, with serial numbers greater than or equal to 16598087. The product was distributed worldwide, including in the United States and numerous foreign countries.
The recall was initiated because the frequency of calibration 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 may drift upwards over time, potentially causing the thermometers to exceed the upper stated accuracy tolerance of +0.2°C.
No specific instructions for consumers are provided in the source text regarding how to dispose of or return the devices.
The recalled product
- Product
- Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
- 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 or equal to 16598087
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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