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Braun BFH175USRecalls & reported problems

Kaz USA, Inc. · Braun Forehead Thermometer · Class 2

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00328785001679), received between Feb 26, 2020 and Mar 29, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (9 reports).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • False Negative Result9
  • Insufficient Device Problem Information2
  • Defective Device1
  • Patient Device Interaction Problem1
  • Use of Device Problem1

Patient problems

  • Fever8
  • Insufficient Information1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 29, 2024False Negative Result; False Negative Result

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN MULTIPLE FALSE NEGATIVE READINGS ON HER INFANT. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE CONSISTANTLY 4.6-4.8°F LOW, AND A FEVER OF 100.8°F WAS LATER CONFIRMED BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE INFANT IS DOING WELL NOW.

    Patient problems: Fever

    MAUDE report 19002876 ↗
  • MalfunctionJan 11, 2024False Negative Result; Use of Device Problem; Patient Device Interaction Problem; False Negative Result; Use of Device Problem; Patient Device Interaction Problem

    A CONSUMER REPORTED THAT HIS THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HIS CHILD. THE DEVICE ALLEGEDLY GAVE A READING OF 96.1°F, AND A FEVER OF 99.2°F WAS LATER CONFIRMED BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW.

    Patient problems: Fever

    MAUDE report 18496386 ↗
  • MalfunctionJan 25, 2023False Negative Result; False Negative Result

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HERSELF. THE DEVICE ALLEGEDLY GAVE A READING OF 97.1°F, AND A FEVER OF 103°F WAS LATER CONFIRMED AT AN URGENT CARE CLINIC. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Patient problems: Fever

    MAUDE report 16243725 ↗
  • MalfunctionJan 28, 2022False Negative Result; False Negative Result

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HERSELF. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 3.2°F LOWER THAN WAS LATER MEASURED AT A DOCTOR'S OFFICE. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAD REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Patient problems: Fever

    MAUDE report 13388764 ↗
  • MalfunctionNov 12, 2021False Negative Result; False Negative Result

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER SON. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 3.5-4°F LOWER THAN WAS LATER MEASURED AT A DOCTOR'S OFFICE. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAD REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Patient problems: Fever

    MAUDE report 12802666 ↗
  • MalfunctionOct 15, 2021False Negative Result; False Negative Result

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER DAUGHTER. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 3-4°F LOWER THAN WAS LATER MEASURED BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAD REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Patient problems: Fever

    MAUDE report 12638535 ↗
  • MalfunctionJul 23, 2021False Negative Result; Defective Device; False Negative Result; Defective Device

    A CONSUMER REPORTED THAT THEIR THERMOMETER HAD GIVEN FALSE NEGATIVE READINGS ON HERSELF. THE DEVICE ALLEGEDLY ALWAYS GAVE READINGS AROUND 95°F, SHE STATED THAT THE UNIT WAS READING 3.1°F LOWER THAN WHAT WAS LATER MEASURED BY A DOCTOR, WHERE A READING OF 98.1°F WAS OBTAINED. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE DEVICE BE RETURNED TO OUR COMPANY FOR TESTING.

    Patient problems: Insufficient Information

    MAUDE report 12217370 ↗
  • MalfunctionJul 15, 2020False Negative Result; Insufficient Device Problem Information; False Negative Result; Insufficient Device Problem Information

    A CONSUMER REPORTED THAT HIS THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER MOTHER. THE DEVICE ALLEGEDLY GAVE A READINGS THAT WERE 4.5°F LOWER THAN WHAT WAS LATER MEASURED AT AN EMERGENCY ROOM. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Patient problems: Fever

    MAUDE report 10279722 ↗
  • MalfunctionFeb 26, 2020False Negative Result; Insufficient Device Problem Information; False Negative Result; Insufficient Device Problem Information

    A CONSUMER REPORTED THAT HIS THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER SON. THE DEVICE ALLEGEDLY GAVE A READINGS THAT WERE 7.5°F LOWER THAN WHAT WAS LATER MEASURED BY THEIR PEDIATRICIAN. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Patient problems: Fever

    MAUDE report 9756689 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.