Continuous Measurement Thermometer
General Hospital · 21 CFR 880.2910
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
Recent MDR events
1,303 adverse event reports on file
- BraunJul 30, 2026MalfunctionKaz Usa, Inc., A Helen Of Troy Company1314800-2026-00017
- General Purpose Probe, 400 Series 12FR (+/-0.2C)Jul 30, 2026MalfunctionDeroyal Cientifica De Latinoamerica S.r.l9613793-2026-00011
- MedlineJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07879
- BRAUNJul 27, 2026MalfunctionKaz Usa, Inc., A Helen Of Troy Company1314800-2026-00016
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07091
- MEDLINEJul 3, 2026MalfunctionMedline Industries, Lp1417592-2026-04083
- MEDLINEJul 3, 2026MalfunctionMedline Industries, Lp1417592-2026-04082
- BRAUNJul 3, 2026MalfunctionKaz Usa, Inc., A Helen Of Troy Company1314800-2026-00013
- BRAUNJul 2, 2026MalfunctionKaz Usa, Inc., A Helen Of Troy Company1314800-2026-00012
- BRAUNJun 28, 2026MalfunctionKaz Usa, Inc., A Helen Of Troy Company1314800-2026-00011
Event type breakdown
Recalls
18 recall events for this product code
- Baxter Healthcare CorporationOpen, ClassifiedOct 23, 2025
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 Sure
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.
Z-0233-2026 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedJul 11, 2024
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The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
Z-2339-2024 · View FDA record ↗ - Philips Consumer LifestyleTerminatedFeb 22, 2018
Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
Device may provide inaccurate measurements.
Z-0689-2018 · View FDA record ↗ - Bestmed, LLCTerminatedDec 16, 2015
Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top
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.
Z-0412-2016 · View FDA record ↗ - Vital Signs Devices, a GE Healthcare CompanyTerminatedAug 13, 2013
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
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
Z-1959-2013 · View FDA record ↗ - Walgreen CompanyTerminatedJan 11, 2012
Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model WIC551226
The thermometers have been reported to have inaccurate readings
Z-0506-2012 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedApr 18, 2006
STS-400 Level1 Skin Temperature Sensor with 400 Series Thermistor
Product temperature readings may be 2C higher than the actual temperature
Z-0767-06 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedApr 18, 2006
TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor
Product temperature readings may be 2C higher than the actual temperature
Z-0768-06 · View FDA record ↗ - Omron Healthcare, Inc.TerminatedFeb 4, 2006
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 measuremen
Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.
Z-0466-06 · View FDA record ↗ - Welch Allyn IncTerminatedJan 16, 2004
Sure Temp Plus Model 690/692 Oral Temperature Probes
Mechanical setting errors that result in calibration errors.
Z-0354-04 · View FDA record ↗
Registered firms
1,330 firms currently registered for this product code
Supercomal Medical Products, Sdn Bhd
SUNGAI PETANI Kedah, MY
Sevenground Trading B.v.
Dordrecht Zuid-Holland, NL
Healthtex Distributors, Inc.
Miami, FL, US
Brain Tunnelgenix Technologies Corporation
Aventura, FL, US
Kunshan Radiant Innovation Co., Ltd.
JIANGSU PROVINCE, CN
Wenzhou Caretek Medical Device Co., Ltd
Wenzhou Zhejiang, CN
Becton, Dickinson And Company
Irvine, CA, US
Empatica S.r.l.
Milano, IT
Pac-dent Inc.
Brea, CA, US
Philips North America Llc
ANDOVER, MA, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Asia Connection Co., Ltd.
New Taipei City, TW
Coopersurgical, Inc.
Trumbull, CT, US
Joytech Healthcare Co.,ltd.
Hangzhou Zhejiang, CN
Hubdic Usa Inc
Carson, CA, US
Shenzhen Bsx Technology Electronics Co.,ltd
Shen Zhen Guangdong, CN
Radiant Innovation Inc.
HSINCHU, TW
Med-linket Corp
Alhambra, CA, US
Easy Healthcare Corporation
Darien, IL, US
Amplim, Llc
San Francisco, CA, US
Midwest Sterilization Corp.
JACKSON, MO, US
Flash Global
Lockbourne, OH, US
Km Medical
North York Ontario, CA
510(k) clearances
798 clearances for this product code
- Unimed Medical Supplies, Inc.Jun 5, 2026
K253162 · Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
- Shenzhen Med-Link Electronics Tech Co., Ltd.Jan 8, 2026
K251160 · Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- Shenzhen AOJ Medical Technology Co., Ltd.Jun 23, 2025
K250470 · Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
- Shenzhen Medke Technology Co., Ltd.Jun 20, 2025
K243000 · Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.May 22, 2025
K250878 · YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
- Guangzhou Daxin Health Technology Co., Ltd.Apr 25, 2025
K243082 · Infrared Thermometer
- Aion Biosystems, Inc.Mar 14, 2025
K250401 · AION TempShield
- Shenzhen Finicare Co., Ltd.Feb 14, 2025
K243136 · Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)