DeRoyal 81-02S409Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00749756805353), received between Sep 30, 2025 and Feb 19, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Incorrect Interpretation of Signal

  A DISTRIBUTING FACILITY REPORTED, "DURING INTRAOPERATIVE TEMPERATURE MONITORING, THE PATIENT'S TEMPERATURE READINGS ON THE MONITOR WERE UNSTABLE. ALTHOUGH THE PATIENT'S ACTUAL TEMPERATURE WAS 36.2°C, THE MONITOR DISPLAYED VALUES OF 34°C TO 35°C EVERY FEW MINUTES DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388037 ↗
• MalfunctionFeb 11, 2026Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "THE NURSES ON TODAY CONFIRMED THAT THEY HAVE BEEN HAVING EXCESSIVE PROBLEMS WITH THE TEMP PROBES. THE PROBES WORK OK FOR HOURS AT A TEMP OF 37, THEN SUDDENLY DROP TO REALLY LOW TEMPS (LIKE 6), AND BOUNCE AROUND SOMETIMES RETURNING TO THE BASELINE TEMP FOR A PERIOD, SOMETIMES NO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314338 ↗
• MalfunctionJan 15, 2026Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "THE TEMPERATURE VALUES SHOWN ARE INACCURATE. FOR EXAMPLE, THE TEMPERATURE VALUE CHANGES FROM 25°C TO 30°C AND FROM 30°C TO 25°C SUDDENLY AND THE CONNECTIONS ARE UNSTABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085008 ↗
• MalfunctionJan 2, 2026Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "BEFORE THE OPERATION, THE PATIENT'S BODY TEMPERATURE MEASURED IN THE HOSPITAL ROOM WITH A THERMOMETER WAS IN THE 35°C RANGE. AFTER MOVING TO THE OPERATING ROOM, THE TEMPERATURE MEASURED AT THE NASOPHARYNX USING THIS PRODUCT INDICATED A VALUE IN THE 39°C RANGE. WHEN ANOTHER UNIT OF 81-02S409 WAS USED TO MEASURE THE NASOPHARYNGEAL TEMPERATURE, THE RESULT WAS 35°C. THE PRODUCT WAS USED IN THE USUAL MANNER, AND DURING THE PRIOR-TO-USE CHECK, THE APPEARANCE WAS INSPECTED AND NO EXTERNAL DAMAGE OR ABNORMALITIES WERE FOUND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943872 ↗
• MalfunctionDec 23, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  A USER FACILITY REPORTED THROUGH A MEDWATCH, "WHEN PLACING ESOPHAGEAL TEMP PROBES, THEY WILL WORK FOR A FEW MINUTES AND THEN THEY BOUNCE AROUND WITH EXCESSIVELY HIGH AND LOW TEMPS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876854 ↗
• MalfunctionOct 29, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "GETTING NUMEROUS COMPLAINTS THAT THEY ARE "GLITCHY" AND NOT READING THE CORRECT TEMPERATURE AND OFTEN READING REALLY LOW, ONE I KEPT WAS READING A TEMP OF 18".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416849 ↗
• MalfunctionSep 30, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  A USER FACILITY REPORTED, "THE HEAD OF ANESTHESIOLOGY, SAID THEY HAVE HAD ON GOING ISSUES WITH THE TEMP DISPLAYED BEING WAY OFF. HE SENT A VIDEO OF THE TEMP JUMPING ALL OVER THE PLACE. HE ALSO SAID THAT THEY HAVE TO GO THROUGH ABOUT 3 PROBES TO FIND ONE THAT WORKS. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23180102 ↗