Braun BNT400BUSRecalls & reported problems
Kaz USA, Inc. · Braun No Touch Forehead Thermometer · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00328785001648), received between Jul 23, 2021 and Nov 17, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (2 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
Device problems
- False Negative Result2
- Patient Device Interaction Problem2
- Use of Device Problem2
Patient problems
- Fever2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2021False 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 A THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER MOTHER, WHO WAS RECOVERING FROM COVID-19 AT THE TIME. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 4-5°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 12832556 ↗MalfunctionJul 23, 2021False 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 THEIR THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER DAUGHTER. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE APPROXIMATELY 6.3°F LOWER THAN WHAT WAS LATER MEASURED AT A HOSPITAL, WHERE A FEVER WAS CONFIRMED. THE CONSUMER STATED THAT THE LOW READINGS MAY HAVE CAUSED A DELAY IN MEDICAL ATTENTION. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW.
Patient problems: Fever
MAUDE report 12217368 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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