DeRoyal FNICU-37Recalls & reported problems

Deroyal Industries, Inc. · Neo. Temp Probe 12 Pink · Class 2

Data updated Oct 16, 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 00749756885447), received between Aug 9, 2024 and Aug 9, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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

Hyperthermia1

Recent adverse event reports

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

MalfunctionAug 9, 2024Device Sensing Problem; Device Sensing Problem
A USER FACILITY REPORTED, "BABY TEMPERATURE IS READING HYPOTHERMIC AND IT IS GETTING THE BABIES TOO HOT."
Patient problems: Hyperthermia
MAUDE report 19950682 ↗

Device details

UDI-DI	`00749756885447`
Brand	DeRoyal
Model	FNICU-37
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	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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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