Cardinal Health recalls Genius 2 Tympanic Thermometers (OEM Item 303062) made after Oct 2016 due to calibration drift causing inaccurate readings. Affected units may show temperatures higher than specified.
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
Take action
Contact the company
📍Recalling firmCardinal Health 200, LLC15 Hampshire St Bldg 5 · Mansfield, MA 02048-1113
✎ GovInfoNow plain-language explainer
Cardinal Health is recalling Genius 2 Tympanic Thermometers made after October 2016 because they may drift out of calibration over time, leading to falsely high temperature readings. This could cause unnecessary medical concerns if used for fever checks. Read more at govinfonow.com/recall/66594-genius-2-tympanic-thermometer-recall-calibration-drift-risk.
“Genius 2 Tympanic Thermometer Recall: Calibration Drift Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66594-genius-2-tympanic-thermometer-recall-calibration-drift-risk. Based on FDA recall #Z-0992-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0992-2020%22&limit=1).
Cardinal Health 200, LLC recalled Genius 2 Tympanic Thermometers due to potential calibration drift exceeding accuracy tolerances, the FDA said on Oct. 28, 2019. The agency announced the Class II recall under number Z-0992-2020.
The FDA stated that the calibration frequency in the operating manual may not keep thermometers within the stated accuracy range. Measurement readings drift upwards over time, potentially exceeding the upper tolerance of +0.2°C for Genius 2 models.
Context
GovInfoNow's records show Cardinal Health 200, LLC has 59 other recalls on record since June 27, 2017. Other recent recalls include Presource Packs with Microstream Components (Aug. 19, 2026), Presource Convenience Kits (Aug. 10, 2026), and Presource Packs Containing Stryker tube sets (Aug. 18, 2026). Similar product recalls include the Covidien Mon-a-Therm Temperature Probe (April 23, 2026) and the Boston Scientific LUX-DX II Arrythmia Detector (March 30, 2026).
How to tell if you have this one
Check for the model name 'Genius 2 Tympanic Thermometer' with OEM Item Code 303062. The product was made after October 1, 2016, and has a serial number greater than or equal to 16597907.
Brand
Cardinal Health
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide Distribution - US Nationwide and Foreign in the countries of: Australia Austria Belgium Canada Canary Islands Chile Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana French Polynesia Gabon Germany Gibraltar Greece Guadeloupe Hong Kong Iran, Islamic Republic Of Ireland Israel Italy Kuwait Liechtenstein Luxembourg Martinique Mayotte Mexico Netherlands New Caledonia New Zealand Norway Panama Philippines Poland Portugal Puerto Rico Qatar Reunion Romania San Marino Saudi Arabia Singapore Slovakia Slovenia South Africa South Korea Spain Swaziland Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom
Recall number
Product, codes & lots
Quantity
Z-0990-2020
Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000; All product manufactured after October 1, 2016; Serial Numbers greater than or equal to 16598087
30142 US; OUS 113841
Z-0991-2020
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013; All product manufactured after December 4, 2017; Serial Numbers greater than or equal to N17700101
7425 US; OUS 214278
Z-0992-2020
Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062; All product manufactured after October 1, 2016; Serial Numbers greater than or equal 16597907
3619 OUS
Z-0993-2020
Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063; All product manufactured after December 10, 2017; Serial Numbers greater than or equal to N17606406
in total 37567 units US; 335573 OUS
Z-0994-2020
Genius 2 Tympanic Thermometer Private Label Item Code: 3069; All product manufactured after October 1, 2016; Serial Numbers greater than N16601357
in total 37567 units US; 335573 OUS
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for a serial number starting with 16597907 or higher on the thermometer.
Verify Model
Confirm the product is the Genius 2 Tympanic Thermometer with OEM Item Code 303062.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide and Foreign in the countries of: Australia Austria Belgium Canada Canary Islands Chile Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana French Polynesia…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0992-2020 (October 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0992-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.