Mon-a-Therm 90050 (UDI 20884521031606)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884521031606), received between May 6, 2019 and Jul 7, 2025 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “High Readings” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 2, 2024Device Damaged Prior to Use; High Readings; Incomplete or Inadequate Connection; Device Damaged Prior to Use; High Readings; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD TEMPERATURE RESULTS ISSUE AND A DAMAGE CONNECTOR. THE THERMAL PROBE FI RST RECORDED A TEMPERATURE OF 34.1 DEGREES IN THE PATIENT AND THEN THE TEMPERATURE ROSE SHARPLY (IN LESS THAN 2 MINUTES) TO 40.5 DEGREES SUSPECTING A POTENTIAL MALIGNANT HYPERTHERMIA IN THE PATIENT. AFTER CONTROL BY TYMPANIC THERMOMETER, THE TEMPERATURE WAS 35.1 DEGREES IN EACH EAR. THE THERMAL PROBE WAS THEN REMOVED. UNFORTUNATELY, THIS IS NOT THE FIRST TIME THAT THIS TYPE OF THERMAL PROBE HAS FOUND ERRONEOUS DATA.  IN ADDITION, WHEN REMOVING THE THERMAL PROBE, THE CONNECTOR SEPARATED FROM THE REST OF THE THERMAL PROBE AND GOT STUCK ON THE CABLE CONNECTING TO THE SCOPE (AS WITH EACH REMOVAL) COMPLICATING THE CHANGE OF THERMAL PROBE. IT WAS THEN NOT POSSIBLE TO PUT BACK A THERMAL PROBE, THE THERMAL MONITORING WAS INTERRUPTED FOR THIS PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18636022 ↗
• MalfunctionJan 19, 2024Erratic or Intermittent Display; Incorrect Measurement; Erratic or Intermittent Display; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, AN ANOMALOUS TEMPERATURE MEASUREMENTS WHEN USING RECTAL SENSOR FOR PATIENT ON THERAPEUTIC HYPOTHERMIA PROTOCOL IN NEONATAL INTENSIVE CARE. THE PATIENT HAD A SERIOUS ILLNESS INJURY.

  Patient problems: Hypothermia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544643 ↗
• InjuryJan 19, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, AN ANOMALOUS TEMPERATURE MEASUREMENTS WHEN USING RECTAL SENSOR FOR PATIENT ON THERAPEUTIC HYP OTHERMIA PROTOCOL IN NEONATAL INTENSIVE CARE.

  Patient problems: Hypothermia

  MAUDE report 18544614 ↗
• MalfunctionJun 16, 2022Fitting Problem; Device Damaged Prior to Use; High Readings; Fitting Problem; Device Damaged Prior to Use; High Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD A BROKEN HOSE AND CLIP. IT WAS UNABLE TO FIT IN THE HOLE AND THE TEMPERATURE WAS DIFFERENT FROM ANOTHER DEVICE (TYMPANIC THERMOMETER). THE THERMAL PROBE FIRST RECORDED A TEMPERATURE OF 34.1 DEGREES IN THE PATIENT THEN THE TEMPERATURE ROSE SUDDENLY (IN LESS THAN 2 MIN) TO 40.5 DEGREES. AFTER CONTROL BY TYMPANIC THERMOMETER, THE TEMPERATURE WAS 35.1 DEGREES IN EACH EAR. THE CABLE WAS REPLACED TO RESOLVE THE FAILURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713039 ↗
• InjuryOct 31, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE'S NASAL TEMPERATURE PROBE HAD AN ISSUES THAT CAUSED TRAUMA TO PATIENT'S NOSE, IT WAS SLIGHTLY LARGER AND STIFFER AT THE END OF THE PROBE, CONSEQUENCES HAD BEEN SEVERE BLEEDING.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 10767270 ↗
• InjuryOct 31, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE'S NASAL TEMPERATURE PROBE HAD AN ISSUES THAT CAUSED TRAUMA TO PATIENT'S NOSE. IT WAS SLIGHTLY LARGER AND STIFFER AT THE END OF THE PROBE. CONSEQUENCES HAD BEEN SEVERE BLEEDING WHICH RESULTED TO PATIENT HAD TO UNDERGO PLASTIC SURGERY.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 10767214 ↗
• InjuryOct 31, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE'S NASAL TEMPERATURE PROBE HAD AN ISSUES THAT CAUSED TRAUMA TO PATIENT'S NOSE WHICH WAS NASAL BLEEDING AFTER NASAL TEMPERATURE PROBE INSERTION.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 10767196 ↗
• InjurySep 9, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, DURING CYTOSTATICA TREATMENT IN THE ABDOMEN, THE PROBE WAS PLACED. AFTER THE PROCEDURE, THE DISTAL PART WAS MISSING AND WAS FOUND AFTER THE ABDOMEN WAS OPENED AGAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 10512178 ↗
• MalfunctionMay 6, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE TEMPERATURE HAD A LOW DISPLAY. IT WAS REPORTED THAT THE DEVICE WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583150 ↗