DeRoyal 81-1010HPRecalls & reported problems

Deroyal Industries, Inc. · Cable · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756140249), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Sensing Problem” (1 report).

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

Device Sensing Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 16, 2025Device Sensing Problem; Device Sensing Problem
A USER FACILITY REPORTED, "SIGNIFICANT FLUCTUATIONS IN TEMPERATURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815359 ↗

Device details

UDI-DI	`00749756140249`
Brand	DeRoyal
Model	81-1010HP
Company	Deroyal Industries, Inc.
Product code	FLL · Thermometer, electronic, clinical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 20, 2021

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.