DeRoyal HNICU-05Recalls & reported problems

Deroyal Industries, Inc. · HYDRO-TEMP® Cover with Foam and Acrylic · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 00749756166331), received between Sep 25, 2020 and Sep 25, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Device problems

Detachment of Device or Device Component1
Mechanical 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.

MalfunctionSep 25, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
THE TEMPERATURE PROBE COVER DOES NOT FIT WELL ON INFANT'S SKIN. IT EASILY FALLS OFF, AND DOES NOT REGULATE TEMPERATURE APPROPRIATELY, WHICH CAUSES INFANTS TO RUN HOT OR COLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10585710 ↗

Device details

UDI-DI	`00749756166331`
Brand	DeRoyal
Model	HNICU-05
Company	Deroyal Industries, Inc.
Product code	FMT · WARMER, INFANT RADIANT
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 11, 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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All WARMER, INFANT RADIANT devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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