DeRoyal HNICU-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756312929), received between Aug 7, 2024 and Dec 16, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Explosion” (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.

Most reported problems

Recent adverse event reports

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

• InjuryDec 16, 2025Explosion; Explosion

  A USER FACILITY REPORTED, "THE PRODUCT "EXPLODED" DURING USE OF THE PRODUCT. THE PROVIDER HAD AN EXPOSURE TO THEIR EYE."

  Patient problems: Eye Irritation; Local Reaction; Rash

  MAUDE report 23815363 ↗
• InjuryAug 7, 2024Explosion; Explosion

  PHLEBOTOMIST IS ACTIVATING THE HEEL WARMER TO USE TO WARM PATIENT HAND. WHEN SHE WAS SQUEEZING IT, IT BURST AND EXPLODED TO HER RIGHT EYE. PHLEBOTOMIST SENT TO ER FOR TREATMENT. NO AFTER EFFECTS NOTED PER THEIR EMAIL.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19928696 ↗