DeRoyal HNICU-26Recalls & reported problems
Deroyal Industries, Inc. · HYDRO-TEMP® Neonatal Temperature Skin Sensor · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00749756032384), received between Jul 23, 2021 and Dec 16, 2025 — classified as 2 malfunctions.
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
Most reported problems
Device problems
- Device Sensing Problem1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Output Problem1
- Unable to Obtain Readings1
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.
MalfunctionDec 16, 2025Device Sensing Problem; Device Sensing Problem
A USER FACILITY REPORTED, "WE HAD OUR BIOMED CHECK OUT THE PROBES COMPARED TO THE OHMEDA PROBES WE ARE CURRENTLY USING AND WE FOUND TWO ALARMING ISSUES WITH IT. THE FIRST IS THAT THE DEROYAL PROBE HAD A VERY LARGE LAG TIME, MINUTES, BEFORE IT SENSES THE NEW TEMPERATURE. THE SECOND ISSUE IS THAT WHEN IT DID CHANGE TEMPERATURES, IT WAS ABOUT 3 CELCIOUS OFF FROM THE OHMEDA PROBE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815386 ↗MalfunctionJul 23, 2021Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
TEMPERATURE READINGS WAS COMING UP TO 36°C WHEN THE ACTUAL READINGS SHOWED 37.5°C.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12220788 ↗
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- DeRoyal HNICU-37Deroyal Industries, Inc. · WARMER, INFANT RADIANT25 reports
- F&P Neopuff RD900AFUFisher & Paykel Healthcare Limited · Warmer, Infant Radiant18 reports
- DeRoyal HNICU-03Deroyal Industries, Inc. · WARMER, INFANT RADIANT5 reports
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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