Minncare HD 3029764Recalls & reported problems

Medivators Inc. · Minncare HD (4 x 1 Gallon) · Class 2

Data updated Oct 16, 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 00724995223298), received between Dec 9, 2024 and Aug 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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

Adverse Event Without Identified Device or Use Problem1
Leak/Splash1

Patient problems

Aspiration/Inhalation1
Pain1

Recent adverse event reports

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

MalfunctionAug 29, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT FIVE EMPLOYEES EXPERIENCED INHALATION/IRRITATION EFFECTS WHILE CLEANING UP DISINFECTANT THAT HAD LEAKED FROM TWO BOTTLES OF MINNCARE HD DISINFECTANT INSIDE A CLOSET. THE EMPLOYEES DID NOT SEEK MEDICAL TREATMENT.
Patient problems: Aspiration/Inhalation
MAUDE report 22923458 ↗
MalfunctionDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT AN EMPLOYEE EXPERIENCED AN "ALTERED LEVEL OF CONSCIOUSNESS" DUE TO INHALATION EXPOSURE WHILE HANDLING MINNCARE HIGH-LEVEL DISINFECTANT. THE EMPLOYEE IMMEDIATELY REMOVED HIMSELF FROM THE AREA INTO FRESH AIR AND CONTACTED POISON CONTROL. NO MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Pain
MAUDE report 20878595 ↗

Device details

UDI-DI	`00724995223298`
Brand	Minncare HD
Model	3029764
Company	Medivators Inc.
Product code	NIH · Disinfectant, subsystem, water purification
Class	Class 2
FDA submission	K133724
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 3, 2024

Device type (GMDN): Organic peroxy acid device sterilant, single-use

A substance in liquid or powder (reconstituted with water) form that includes an organic peroxy acid (e.g., peracetic acid, perpyruvic acid) as its primary agent intended to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused.

Other Disinfectant, subsystem, water purification devices

Minncare HD 3029765
Medivators Inc. · Disinfectant, Subsystem, Water Purification
2 reports

All Disinfectant, subsystem, water purification 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 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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