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FLLClass 2

Continuous Measurement Thermometer

FDA adverse event reports and recall history for continuous measurement thermometer (product code FLL), from the public MAUDE corpus and the live FDA recall database.

Total reports
1,636
Deaths
13
Injuries
173
Malfunctions
1,296

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

  • 2026-09-22Open, ClassifiedUnder Investigation by firm

    REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

    Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

  • 2025-10-23Open, ClassifiedProcess control

    Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers

    Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.

  • 2024-07-11Open, ClassifiedProcess control

    Braun Thermoscan PRO 6000 Ear Thermometer

    The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).

  • 2018-02-22TerminatedUse error

    Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)

    Device may provide inaccurate measurements.

  • 2015-12-16TerminatedProcess control

    Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries installed, a Quick Start Guide, and an Instruction Manual booklet. Product Usage: Device is a handheld thermometer that employs a thermistor sensor intended for people to take a human body temperature at the temporal artery location, the area between the outer corner of the eye and the hairline directly over the temporal artery.

    An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user.

  • 2013-08-13TerminatedUse error

    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.

    GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe

  • 2012-01-11TerminatedLabeling design

    Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model WIC551226

    The thermometers have been reported to have inaccurate readings

  • 2006-04-18TerminatedOther

    STS-400 Level1 Skin Temperature Sensor with 400 Series Thermistor

    Product temperature readings may be 2C higher than the actual temperature

  • 2006-04-18TerminatedOther

    TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor

    Product temperature readings may be 2C higher than the actual temperature

  • 2006-02-04TerminatedOther

    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

    Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.

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