# FDA recall Z-0993-2020

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2019-10-28.

## Product

Genius 2 Tympanic Thermometer   OEM Tympanic  Item Code: 303063

## 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.

## 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

## Key facts

- **Recall number:** Z-0993-2020
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-28
- **Report date:** 2020-02-12
- **Termination date:** 2022-05-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0993-2020

## Citation

> AI Analytics. FDA recall Z-0993-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0993-2020. Source: US FDA. Licensed CC0.

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