Z-0991-2020Class II

Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013

Name: Z-0991-2020 Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
Creator: Cardinal Health 200, LLC
Published: 2019-10-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-10-28 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013 on 2019-10-28. FDA classified it as Class II and gives the reason as "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 ( 0.2C for Genius 2 and 0.3C for Genius...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0991-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-28
Posted: 2020-02-04
Terminated: 2022-05-17
Recalling firm: Medtronic, Inc.
Product: Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
Product code: FLL Continuous Measurement Thermometer
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 ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Cardinal Health issued Correction Notice and Acknowledgement Form via overnight on October 28, 2019 to the direct consignees. The Medical Device Correction Notice provides instructions to our direct consignees to notify any customers who they may have further distributed affected product as to the market action. Letter states reason for recall, health risk and action to take: Customers are instructed that if they have access to a Genius Checker/Calibrator to calibrate all affected Genius thermometers. Following calibration, customers are to contact Cardinal Health Service & Repair to schedule and arrange for the software update on their Genius Checker/Calibrator. Once the updated Genius Checker/Calibrator has been returned to your facility, recalibrate all thermometers. If a customer does not have access to a Genius Checker/Calibrator, they are instructed to contact Cardinal Health Service & Repair to schedule and arrange for their thermometer(s) to be sent to a service center. Contact Cardinal Health Service & Repair to schedule and arrange for your thermometer(s) to be sent to one of our service centers. Monday Friday between 8:00am - 8:00pm EST Service and Repair Line 877-227-3462, Option 1
Quantity in commerce: 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
Product codes and lots: All product manufactured after December 4, 2017; Serial Numbers greater than or equal to N17700101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0991-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0990-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0991-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0992-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0993-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0994-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04

Product code FLL

K060649Class IIGenius 2 Infrared Tympanic Electronic Thermometer, Model 303000Tyco Healthcare Group LP / cleared 2006-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)