Mon-a-Therm 90050 (UDI 10884521828391)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521828391), received between Nov 14, 2024 and Jan 17, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Low Readings” (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-2273-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Low Readings2
- High Readings1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2025High Readings; High Readings
IT WAS REPORTED THAT DURING USE OF A THERMAL PROBE USED IN PEDIATRICS, IT SHOWED MORE THAN ONE DEGREE OF DIFFERENCE WHEN COMPARED TO A THERMOMETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21182739 ↗MalfunctionNov 21, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE SENSOR'S TEMPERATURE WAS TOO LOW DURING USE COMPARED TO AN EAR THERMOMETER. NO PATIENT OUTCOME WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20748539 ↗MalfunctionNov 14, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE TEMPERATURE OF THE SENSOR WAS TOO LOW DURING USE. THE SENSOR SHOWED 33.4 DEGREES CELSIUS, AND AN EAR THERMOMETER CONFIRMED THE CORRECT TEMPERATURE TO BE 36.8 DEGREES CELSIUS. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 20682876 ↗
Other Thermometer, electronic, clinical devices
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- 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 90044Covidien LP · Thermometer, electronic, clinical1 recall2 reports
- Temperature Probes Esophageal/Rectal Temperature ProbePhilips Medical Systems Hsg · Thermometer, electronic, clinical1 recall1 report
- 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.