Mon-a-ThermRecalls & reported problems across all models
Covidien LP · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Mon-a-Therm model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 3
We found 12 models of Mon-a-Therm by Covidien LP in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2018 and Mar 11, 2026 — classified as 7 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Low Readings” (12 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Mon-a-Therm recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 23, 2026Open, Classified
Temperature probe devices lack FDA clearance.
Z-2273-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 23, 2026Open, Classified
Temperature probe devices lack FDA clearance.
Z-2272-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 23, 2026Open, Classified
Temperature probe devices lack FDA clearance.
Z-2271-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Mon-a-Therm problems
Device problems
- Low Readings12
- High Readings9
- Incorrect Measurement4
- Appropriate Device Problem Term/Code Not Available3
- Device Damaged Prior to Use3
- Use of Device Problem2
- Air Leak1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient6
- Hypothermia4
- Insufficient Information4
- Blood Loss3
- Hemorrhage/Blood Loss/Bleeding3
- Injury3
- No Information2
Mon-a-Therm models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Mon-a-Therm 90050Thermometer, electronic, clinical1 recall3 reports
- Mon-a-Therm 90044Thermometer, electronic, clinical1 recall2 reports
- Mon-a-Therm 90042STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS1 recall0 reports
- Mon-a-Therm 90050Thermometer, electronic, clinical14 reports
- Mon-a-Therm 90056CATHETER, UROLOGICAL4 reports
- Mon-a-Therm 90051CATHETER, UROLOGICAL4 reports
- Mon-a-Therm 90045Thermometer, electronic, clinical3 reports
- Mon-a-Therm 90044Thermometer, electronic, clinical3 reports
- Mon-a-Therm 502-0401AThermometer, electronic, clinical1 report
- Mon-a-Therm 90041STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS1 report
- Mon-a-Therm 90049STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS1 report
- Mon-a-Therm 90045Thermometer, electronic, clinical1 report
Recent Mon-a-Therm adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Low Readings
IT WAS REPORTED THAT THE SKIN SENSOR DISPLAYED TEMPERATURE READINGS BELOW THE ACTUAL TEMPERATURE WHICH IS 33-34 DEGREES CELSIUS. THE HOSPITAL TESTED THE SKIN SENSORS ON DIFFERENT STAFF MEMBERS, ON DRY SKIN AND VARIOUS PLACEMENTS, TO CONFIRM THE ISSUE. THE CABLE USED WAS THE SAME AS THAT USED FOR ESOPHAGUS SENSORS AND WAS BELIEVED TO BE FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571726 ↗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 ↗MalfunctionJul 7, 2025Low Readings; Low Readings
IT WAS REPORTED THAT AFTER CONNECTING THE CABLE, A 5°C WAS DISPLAYED, WHICH WAS AN IMPOSSIBLE VALUE, SO THE SENSOR WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22418596 ↗MalfunctionJun 25, 2025High Readings; High Readings
IT WAS REPORTED THE DEVICE HAD HIGHER TEMPERATURE DISPLAY AFTER PATIENT INSTALLATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22333035 ↗MalfunctionJun 25, 2025High Readings; High Readings
IT WAS REPORTED THAT THE DEVICE HAD HIGHER TEMPERATURE DISPLAY AFTER PATIENT INSTALLATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332983 ↗MalfunctionJun 25, 2025High Readings; High Readings
IT WAS REPORTED THAT THE DEVICE HAD HIGHER TEMPERATURE DISPLAY AFTER PATIENT INSTALLATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332874 ↗MalfunctionJun 19, 2025High Readings; High Readings
IT WAS REPORTED THAT THE DEVICE HAD HIGHER TEMPERATURE DISPLAY AFTER PATIENT INSTALLATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22291903 ↗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 25, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE SKIN TEMPERATURE SENSORS WERE EVALUATED ALONG WITH URINARY CATHETERS WITH TEMPERATURE SENSORS. IT SHOWED TEMPERATURES THAT WERE TOO LOW, IT WAS 2°C LOWER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773435 ↗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 ↗MalfunctionNov 13, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE SKIN TEMPERATURE SENSORS WERE EVALUATED ALONG WITH FOLEY CATHETERS WITH TEMPERATURE SENSORS. ALL FAULTY SENSORS SHOWED TEMPERATURES THAT WERE TOO LOW, WITH MOST READINGS BEING 1-1.5°C LOWER, AND SOME EVEN 2°C LOWER, INCLUDING ONE SPECIFIC SENSOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20678102 ↗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 ↗MalfunctionApr 18, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE TEMPERATURE PROBE WAS IN PLACE FOR 48 HOURS. AFTER REMOVAL FOR INTIMATE WASHING, REINSTALLATION OF THE DEVICE. MALFUNCTION WITH TEMPERATURE DIFFERENCE OF UP TO 2 DEGREES LESS THAN THE SOCKET TYMPANIC. CHANGING THE PROBE, USING THE SAME REFERENCE, THE SAME BATCH AND IT HAD SIMILAR PROBLEM. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19136809 ↗MalfunctionApr 17, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE TEMPERATURE PROBE WAS IN PLACE FOR 48 HOURS. AFTER REMOVAL FOR INTIMATE WASHING, REINSTALLATION OF THE DEVICE. MALFUNCTION WITH TEMPERATURE DIFFERENCE OF UP TO 2 DEGREES LESS THAN THE SOCKET TYMPANIC. CHANGING THE PROBE, USING THE SAME REFERENCE, THE SAME BATCH AND IT HAD SIMILAR PROBLEM. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19126918 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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