CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Genius 2 Tympanic Thermometer OEM Tympanic recalled

Cardinal Health 200 is recalling Genius 2 Tympanic Thermometer OEM Tympanic, distributed nationwide in the US. The recall was initiated on 28 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll product manufactured after December 10, 2017; Serial Numbers greater than or equal to N17606406

Quantity recalledin total 37567 units US; 335573 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0993-2020
FDA event ID: 84202
Recalling firm: Cardinal Health 200, Mansfield, MA
Classification: Class II
Status: Terminated
Recall initiated: 28 Oct 2019
FDA classified: 4 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

28 Oct 2019	Recall initiated by company
4 Feb 2020	Classified by FDA	+99 days
12 Feb 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

All product manufactured after December 10, 2017; Serial Numbers greater than or equal to N17606406

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 84202

This product is part of a recall event; the main page for the event is Genius 2 Tympanic Thermometer OEM Tympanic recalled.

Reported	Class	Recall	Company	Reason	Where
12 Feb 2020	CLASS II	Genius 2 Tympanic Thermometer OEM Tympanic recalled	Cardinal Health 200	Device Malfunction	Nationwide
12 Feb 2020	CLASS II	Genius 2 Tympanic Thermometer Private Label recalled	Cardinal Health 200	Device Malfunction	Nationwide
12 Feb 2020	CLASS II	Genius 2 Tympanic Thermometer (discontinued) recalled	Cardinal Health 200	Device Malfunction	Nationwide
12 Feb 2020	CLASS II	Genius 3 Tympanic Thermometer- electric thermometer recalled	Cardinal Health 200	Device Malfunction	Nationwide

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