Cardinal Health Genius 2 Tympanic Thermometer Recall for Accuracy Drift
Cardinal Health is recalling Genius 2 Tympanic Thermometers because calibration frequency may not ensure readings remain 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling the Genius 2 Tympanic Thermometer (Item Code: 303064). The recall involves 37,567 units distributed in the United States and 335,573 units distributed outside the United States. The affected products were manufactured after December 10, 2017, and have serial numbers greater than or equal to N17606406.
The recall is being issued because the frequency of calibration stated in the operating manual may not ensure that the thermometers always remain within the stated accuracy range. Specifically, measurement readings may drift upwards over time, potentially causing the devices to exceed the upper stated accuracy tolerance of +0.2°C for the Genius 2 model.
The recall is classified as Class II by the U.S. Food and Drug Administration. Consumers and healthcare providers should stop using the affected thermometers and contact Cardinal Health for instructions on replacement or repair.
The recalled product
- Product
- Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
- 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 December 10
- 2017
- Serial Numbers greater than or equal to N17606406
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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