Bair Hugger™ 36000Recalls & reported problems
3m Company · 3M™ Bair Hugger™ Temperature Monitoring Sensor, 25 per case, 36000 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50707387775808), received between Nov 2, 2017 and Nov 2, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software Problem” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Computer Software Problem1
- Device Issue1
- Device Operational Issue1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2017Computer Software Problem; Device Issue; Device Operational Issue; Computer Software Problem; Device Issue; Device Operational Issue
A CUSTOMER REPORTED THAT THE SENSOR ON THE PRODUCT USED WAS CONSISTENTLY READING 3 DEGREES LOWER ON THE FOREHEAD (RIGHT SIDE AND LEFT SIDE) COMPARED WITH ORAL TEMPERATURE TAKEN. THE CUSTOMER OBTAINED ANOTHER SENSOR FROM A DIFFERENT LOT AND PLACED IT ON THE RIGHT FOREHEAD AND ITS READING WAS CONSISTENT WITH THE ORAL TEMPERATURE TAKEN. THIS ISSUE HAD BEEN EXPERIENCED FROM VARIOUS CLINICIANS FROM WITHIN THE SAME FACILITY. THE LOT NUMBER WAS PROVIDED APPLICABLE TO THE PRODUCT OF CONCERN. A RECALL HAS BEEN INITIATED WHICH INCLUDES THE SAME LOT NUMBER REGARDING THIS REPORTED EVENT AND NOT PROVIDING A CORRECT TEMPERATURE. THE ROOT CAUSE HAS BEEN DETERMINED AND CORRECTION ACTION HAS BEEN IMPLEMENTED.
Patient problems: No Information
MAUDE report 6997558 ↗
Other Thermometer, electronic, clinical devices
- Welch Allyn, Inc. 901054Welch Allyn, Inc. · Thermometer, electronic, clinical1 recall221 reports
- Welch Allyn, Inc. 901054Welch Allyn, Inc. · Thermometer, electronic, clinical2 recalls13 reports
- NA B105 VSP3.0 Patient MonitorGE Medical Systems Information Technologies, Inc. · Thermometer, electronic, clinical2 recalls0 reports
- Medline MDSTH1002Medline Industries, Inc. · Thermometer, electronic, clinical65 reports
- Mon-a-Therm 90050Covidien LP · Thermometer, electronic, clinical1 recall3 reports
- Mon-a-Therm 90044Covidien LP · Thermometer, electronic, clinical1 recall2 reports
- CARESCAPE B450 MBA313GE Healthcare Finland Oy · Thermometer, electronic, clinical1 recall1 report
- Temperature Probes Esophageal/Rectal Temperature ProbePhilips Medical Systems Hsg · Thermometer, electronic, clinical1 recall1 report
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page