Severity
Moderate
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
Reported: February 12, 2020 Initiated: October 28, 2019 #Z-0991-2020 7425 US; OUS 214278 units
Cardinal Health 200, LLC issued this FDA Devices recall on February 12, 2020. Classified as Moderate severity (Class II). Approximately 7425 US; OUS 214278 units are affected. The recall was issued because: The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0991-2020) was formally reported on February 12, 2020, with the manufacturer initiating the action on October 28, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Mansfield, MA. Federal records indicate 7425 US; OUS 214278 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: 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 Ge… Distribution data in the federal record shows the product reached: 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 …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
7425 US; OUS 214278
Related Recalls
6
6 from same agency
Product Description
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
Reason for Recall
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.
Details
- Recalling Firm
- Cardinal Health 200, LLC
- Units Affected
- 7425 US; OUS 214278
- 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
- Location
- Mansfield, MA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0991-2020 |
| Date reported | February 12, 2020 |
| Date initiated | October 28, 2019 |
| Recalling firm | Cardinal Health 200, LLC |
| Units affected | 7425 US; OUS 214278 |
| 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 Fren… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013. Recalled by Cardinal Health 200, LLC. Units affected: 7425 US; OUS 214278.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-0991-2020.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0991-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).