Braun IRT6520BUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00328785001914), received between Mar 17, 2022 and Jan 20, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026False Negative Result

  A HOSPITAL REPORTED THAT THE EAR THERMOMETER ALLEGEDLY PROVIDED A LOW TEMPERATURE READING FOR A PEDIATRIC PATIENT. THE CHILD'S TEMPERATURE WAS REPORTEDLY MEASURED AT 37.2°C. A SUBSEQUENT MEASUREMENT USING A MERCURY THERMOMETER ALLEGEDLY SHOWED A TEMPERATURE OF 39.7°C, INDICATING THE PRESENCE OF A FEVER. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT'S DIAGNOSIS OR CLINICAL OUTCOME. THE ONLY INFORMATION AVAILABLE IS THAT A TEMPERATURE DISCREPANCY OCCURRED, AND THE DEVICE WAS REPORTED TO HAVE GIVEN A LOW READING. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

  Patient problems: Fever

  MAUDE report 24126613 ↗
• MalfunctionDec 31, 2025False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT THE THERMOMETER ALLEGEDLY PROVIDED FALSE NEGATIVE READINGS ON THEIR 7 YEAR OLD DAUGHTER. THE DEVICE ALLEGEDLY DISPLAYED A MEASUREMENT OF 37°C, WHILE A FEVER OF 40°C WAS LATER CONFIRMED BY A DOCTOR WHO ADMINISTERED MEDICATION. THERE WERE NO COMPLICATIONS FROM THE INCIDENT, AND THE CHILD IS DOING WELL NOW. KAZ USA, INC. HAD REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

  Patient problems: Fever

  MAUDE report 23938613 ↗
• MalfunctionMay 11, 2025False Negative Result; False Negative Result

  A HOSPITAL REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING ON A PATIENT WHO HAD ALREADY BEEN ADMITTED WITH A LUNG INFECTION. THE DEVICE ALLEGEDLY GAVE A READING OF 36.9°C, AND A FEVER OF 38.9°C WAS CONFIRMED BY A MEDICAL PROFESSIONAL USING A DIFFERENT EAR THERMOMETER. NO INFORMATION WAS PROVIDED ON THE DIAGNOSIS OR CURRENT STATUS OF THE PATIENT. THE ONLY KNOWN INFORMATION PROVIDED WAS THAT A FEVER WAS CONFIRMED BY A MEDICAL PROFESSIONAL, AND OUR DEVICE WAS GIVING FALSE NEGATIVE READINGS. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

  Patient problems: Fever

  MAUDE report 21999806 ↗
• InjuryJan 10, 2025False Negative Result; False Negative Result

  A CONSUMER REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON THEIR INFANT SON. THE DEVICE ALLEGEDLY GAVE READINGS RANGING FROM 36.5 TO 38.9°C. THE CHILD LATER HAD A FEBRILE SEIZURE AND WAS TAKEN TO THE HOSPITAL WHERE A FEVER OF 38.0°C WAS CONFIRMED. THE CHILD WAS ADMITTED TO THE HOSPITAL FOR THREE DAYS. 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: Convulsion/Seizure; Fever

  MAUDE report 21129508 ↗
• MalfunctionNov 30, 2024False Negative Result; False Negative Result

  A HOSPITAL REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING ON A PATIENT WHO WAS FEBRILE DUE TO HIGH LEUKOCYTES CAUSED BY AN INFECTION. THE DEVICE ALLEGEDLY GAVE A READING OF 34°C, AND A FEVER OF 39°C WAS CONFIRMED BY A MEDICAL PROFESSIONAL USING A MERCURY THERMOMETER. NO INFORMATION WAS PROVIDED ON THE DIAGNOSIS OR CURRENT STATUS OF THE PATIENT. THE ONLY KNOWN INFORMATION PROVIDED WAS THAT A FEVER WAS CONFIRMED BY A MEDICAL PROFESSIONAL, AND OUR DEVICE WAS GIVING FALSE NEGATIVE READINGS. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

  Patient problems: Fever

  MAUDE report 20814091 ↗
• MalfunctionMar 17, 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 5-6°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 13798576 ↗