Cardinal Health Genius 3 Tympanic Thermometer Recalled for Accuracy Drift
Cardinal Health is recalling Genius 3 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 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 involves a medical device where the hazard is a risk of harm (inaccurate temperature readings) without reported illness or injury, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling the Genius 3 Tympanic Thermometer (Item Code: 303013). The recall involves 7,425 units in the United States and 214,278 units distributed worldwide. The affected products were manufactured after December 4, 2017, and have serial numbers greater than or equal to N17700101.
The recall was initiated because the frequency of calibration stated in the operating manual may not ensure that the thermometers remain within the stated accuracy range of ±0.3°C. The measurement readings may drift upwards over time, which means the thermometers could exceed the upper stated accuracy tolerance of +0.3°C.
Consumers and healthcare providers should stop using the affected thermometers and contact Cardinal Health for instructions on how to return or replace the devices.
The recalled product
- Product
- Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
- 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 4
- 2017
- Serial Numbers greater than or equal to N17700101
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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