ARC InstaTemp Non-Touch Thermometer 000Recalls & reported problems
Arc Devices USA Inc · InstaTemp Digital Non-Touch Infrared Thermometer intended to be used to measure temperature in infants and adults. This device can be used in the home or in a clinical setting. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391525570006), received between Jun 23, 2017 and Jun 23, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Sensing Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Sensing Problem1
Patient problems
- Fever1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2017Device Sensing Problem; Device Sensing Problem
THE CONSUMER/MOTHER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READINGS. THE DEVICE ALLEGEDLY WAS READING 5-6 DEGREES LOWER THAN THE CHILD'S ACTUAL TEMPERATURE. THE CHILD WAS TREATED AT AN EMERGENCY ROOM WHERE A FEVER WAS CONFIRMED. THE CONSUMER ALSO STATED THAT THE CHILD HAD A FEBRILE SEIZURE. ARC DEVICES HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS.
Patient problems: Fever
MAUDE report 6664576 ↗
Other Thermometer, Electronic, Clinical devices
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- Welch Allyn, Inc. 901054Welch Allyn, Inc. · Thermometer, electronic, clinical2 recalls13 reports
- NA B105 VSP3.0 Patient MonitorGE Medical Systems Information Technologies, Inc. · Thermometer, electronic, clinical2 recalls0 reports
- Medline MDSTH1002Medline Industries, Inc. · Thermometer, electronic, clinical65 reports
- Mon-a-Therm 90050Covidien LP · Thermometer, electronic, clinical1 recall3 reports
- Mon-a-Therm 90044Covidien LP · Thermometer, electronic, clinical1 recall2 reports
- CARESCAPE B450 MBA313GE Healthcare Finland Oy · Thermometer, electronic, clinical1 recall1 report
- Temperature Probes Esophageal/Rectal Temperature ProbePhilips Medical Systems Hsg · Thermometer, electronic, clinical1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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