Z-0466-06

Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used...

Name: Z-0466-06 Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used...
Creator: Omron Healthcare, Inc.
Published: 2005-10-25
License: https://open.fda.gov/license/

Omron Healthcare Co., Ltd. / initiated 2005-10-25 / Terminated

FDA source

Omron Healthcare, Inc. began a recall of Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature... on 2005-10-25. The reason FDA records is "Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0466-06
Status: Terminated
Initiated: 2005-10-25
Posted: 2006-02-04
Terminated: 2007-11-28
Recalling firm: Omron Healthcare Co., Ltd.
Product: Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral, rectal or under arm modes when the ambient temperature is between 50 degrees F and 93.2 degrees F; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061, Made in Philippines; UPC 73796-43600
Product code: FLL Continuous Measurement Thermometer
Reason for recall: Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.
FDA root cause: Other
Action: Omron sent recall letters dated 10/21/05 to all of their direct accounts, informing them that the probe tip could overheat and possibly burn the person whose temperature is being taken. The accounts were instructed to check the lot number on their thermometers immediately to see if they fall within the range of affected thermometers (lots beginning with 01-32, 01-36, 01-37 and 01-38). The accounts were instructed to call Omron at 1-800-634-4350 if their unit is affected to get instructions on how to return the unit to Omron for a refund. Omron issued a press release on 10/24/05 to alert consumers who may have purchased the thermometer at a retail pharmacy, and has posted both the press release and the recall letter on their website at www.omronhealthcare.com.
Quantity in commerce: Approximately 48,000 units
Distribution: Nationwide and internationally to Canada, Chile, Venezuela and Singapore
Product codes and lots: Model Numbers MC-600 (USA) and MC-600CAN (Canada) Lot numbers beginning with 1-32, 1-36, 1-37, 1-38.

Product code FLL

K983887Class IIUp-Grade and Up-Grade ProMedisim, Ltd. / cleared 1999-02-12

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)