DeRoyal 81-02S412EURecalls & reported problems

Deroyal Industries, Inc. · General Purpose Temperature Probe, Soft · Class 2

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756820929), received between Jan 2, 2026 and Jan 2, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (2 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Incorrect Interpretation of Signal2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 2, 2026Incorrect Interpretation of Signal
A USER FACILITY REPORTED, "EXPERIENCED DURING AN ANESTHESIA WHEN USED IN ESOPHAGUS THAT IT JUMP FROM 36,4 TO 7 DEGREES CELSIUS. THEY CHANGED PROBE AND THE SAME HAPPENS, THEY CHANGED MONITOR CABLE AND DIFFERENT SOURCE IN THE MONITOR AND IT STILL HAPPENED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943940 ↗
MalfunctionJan 2, 2026Incorrect Interpretation of Signal
A USER FACILITY REPORTED, "EXPERIENCED DURING AN ANESTHESIA WHEN USED IN ESOPHAGUS THAT IT JUMP FROM 36,4 TO 7 DEGREES CELSIUS. THEY CHANGED PROBE AND THE SAME HAPPENS, THEY CHANGED MONITOR CABLE AND DIFFERENT SOURCE IN THE MONITOR AND IT STILL HAPPENED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943871 ↗

Device details

UDI-DI	`00749756820929`
Brand	DeRoyal
Model	81-02S412EU
Company	Deroyal Industries, Inc.
Product code	FLL · Thermometer, electronic, clinical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): General-purpose patient temperature probe, single-use

A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.