Braun IRT6500USRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00328785000054), received between Jun 3, 2020 and Apr 16, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (10 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2025False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT HIS THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HIS SON. THE DEVICE ALLEGEDLY GAVE CONSISTENT READINGS OF 96.7°F, AND A FEVER OF 101.0°F WAS LATER CONFIRMED BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

  Patient problems: Fever

  MAUDE report 21852780 ↗
• MalfunctionMar 29, 2024False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HIMSELF. THE DEVICE ALLEGEDLY GAVE A READING OF 95.0°F, AND A FEVER OF 100.9°F WAS LATER MEASURED AT A DOCTOR'S OFFICE. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW.

  Patient problems: Fever

  MAUDE report 19002877 ↗
• MalfunctionMar 16, 2023False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER DAUGHTER. THE DEVICE ALLEGEDLY GAVE A READING OF 97.6°F, AND A FEVER OF 101.0°F WAS LATER CONFIRMED BY A DOCTOR. 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 16552802 ↗
• MalfunctionOct 20, 2022False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER FRIENDS' FATHER. THE DEVICE ALLEGEDLY GAVE READINGS AROUND 101°F, AND THE PATIENT WAS LATER TAKEN BY AMBULANCE WHERE A FEVER OF 107°F WAS CONFIRMED BY PARAMEDICS. THE PATIENT WAS TREATED AT A HOSPITAL FOR A FEW DAYS, AND WAS LATER RELEASED. 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 15639239 ↗
• MalfunctionOct 13, 2022False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT HIS THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HIS SON. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 6-7°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 15597516 ↗
• MalfunctionMar 8, 2022False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT HIS THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER SON. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 3-4°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 13693217 ↗
• MalfunctionDec 19, 2021False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT A THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER INFANT. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 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 13041129 ↗
• MalfunctionNov 4, 2021False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT THEIR THERMOMETER HAD GIVEN FALSE NEGATIVE READINGS ON HERSELF. THE DEVICE ALLEGEDLY WAS READING 5.2°F LOWER THAN WHAT WAS MEASURED BY A DOCTOR, WHERE A READING OF 102.8°F WAS OBTAINED. THE PATIENT WAS TRANSPORTED TO A HOSPITAL, AND TREATED FOR A FEVER AND PNEUMONIA. 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: Fever; Pneumonia

  MAUDE report 12750652 ↗
• MalfunctionJun 10, 2020False Negative Result; Insufficient Device Problem Information; False Negative Result; Insufficient Device Problem Information

  A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HERSELF. THE DEVICE ALLEGEDLY GAVE A READING THAT WAS 3.2°F LOWER THAN WHAT WAS LATER MEASURED AT THE HOSPITAL, WHERE A FEVER WAS RECORDED. THE CONSUMER TESTED POSITIVE FOR COVID-19 AND WAS ADMITTED FOR TREATMENT FOR NINE DAYS. 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 10137595 ↗
• MalfunctionJun 3, 2020False Negative Result; Insufficient Device Problem Information; False Negative Result; Insufficient Device Problem Information

  A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER DAUGHTER. THE DEVICE ALLEGEDLY GAVE A READING THAT WAS 5.8 - 6.8°F LOWER THAN WHAT WAS LATER MEASURED AT THE HOSPITAL, WHERE A HIGH FEVER WAS RECORDED. 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, BUT THE CONSUMER STATED THAT THEY HAD ALREADY DISCARDED THE DEVICE.

  Patient problems: Fever

  MAUDE report 10114324 ↗