Minncare HD 3029765Recalls & reported problems
Medivators Inc. · 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 00677964066870), received between May 13, 2024 and May 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- Burn(s)1
- Chemical Exposure1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR MINNCARE HD WAS DROPPED DURING TRANSFER CAUSING THE BOTTLE TO SPLIT AND AN EMPLOYEE WAS SENT TO EMPLOYEE HEALTH FOR INHALATION/IRRITATION. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Chemical Exposure
MAUDE report 19298981 ↗MalfunctionMay 13, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR HAND REQUIRING MEDICAL TREATMENT WHILE HANDLING A LEAKING BOX OF MINNCARE HD. TWO OTHER EMPLOYEES WERE REPORTED TO HAVE A MINOR INJURY DURING CLEAN UP FROM THE LEAK; THE DETAILS OF THE INJURY ARE UNKNOWN.
Patient problems: Burn(s)
MAUDE report 19298980 ↗
Other Disinfectant, Subsystem, Water Purification devices
- Minncare HD 3029764Medivators Inc. · Disinfectant, subsystem, water purification2 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.
How reports and recalls are matched · Editorial policy · Report an error on this page