Mon-a-Therm 90044 (UDI 10884521828384)Recalls & reported problems
Covidien LP · General Purpose Temperature Probe 400TM · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521828384), received between Apr 26, 2024 and Nov 3, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Apr 23, 2026Open, Classified
Temperature probe devices lack FDA clearance.
Z-2272-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Incorrect Measurement2
- Low Readings1
Patient problems
- Hypothermia1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE SENSOR DISPLAYED AN ABNORMAL BODY TEMPERATURE READING OF 33 DEGREES AT THE BEGINNING OF THE OPERATION. THERE WAS AN INABILITY TO MONITOR THE PATIENT¿S TEMPERATURE DURING THE OPERATION, AND POOR MANAGEMENT OF HYPOTHERMIA OCCURRED DUE TO THE LACK OF TEMPERATURE MONITORING. THE ISSUE WAS DESCRIBED AS RECURRING, WITH PREVIOUS MEASURED TEMPERATURES OF 0 OR 17 DEGREES. IT WAS NOT POSSIBLE TO CHANGE THE TEMPERATURE PROBE DURING THE OPERATION IF A MALFUNCTION WAS DETECTED.
Patient problems: Hypothermia
MAUDE report 23460369 ↗MalfunctionApr 26, 2024Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings
ACCORDING TO THE REPORTER, DURING USE, THE READING FROM THE TEMPERATURE PROBE WAS LOW COMPARED TO OTHER DEVICES' READINGS. THE UNIT GAVE 35.2 READING WHILE THE ORAL TEMPERATURE WAS 36.3. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19193856 ↗
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- CARESCAPE B450 MBA313GE Healthcare Finland Oy · Thermometer, electronic, clinical1 recall1 report
- DeRoyal 81-030415Deroyal Industries, Inc. · Thermometer, electronic, clinical1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.