Device recall: Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
Class II FDA enforcement event 84202. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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…
Class II, in the words of FDA
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
Cardinal Health 200, LLC started this device recall on 28 Oct 2019. The firm address in the FDA record is in Mansfield, MA. FDA put the recall in Class II. FDA event 84202 has 5 product records. The first FDA enforcement report date is 12 Feb 2020. The record gives the status Terminated, with the termination date 17 May 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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…
Recalling firm
Cardinal Health 200, LLC, Mansfield, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0990-2020 | Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000 | 30142 US; OUS 113841 | Class II | Terminated | 12 Feb 2020 |
| Z-0991-2020 | Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013 | 7425 US; OUS 214278 | Class II | Terminated | 12 Feb 2020 |
| Z-0992-2020 | Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062 | 3619 OUS | Class II | Terminated | 12 Feb 2020 |
| Z-0993-2020 | Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063 | in total 37567 units US; 335573 OUS | Class II | Terminated | 12 Feb 2020 |
| Z-0994-2020 | Genius 2 Tympanic Thermometer Private Label Item Code: 3069 | in total 37567 units US; 335573 OUS | Class II | Terminated | 12 Feb 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 5Median of the firm: 3
- Events of the firm on the register
- 59
Other events of the firm
Official channels
- FDA enforcement report Z-0990-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 84202. https://recallregister.com/fda/ii/84202/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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…
- What quantity of product is in FDA event 84202?
- The event has 5 product records. The first record gives this quantity:
30142 US; OUS 113841
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.