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Vicks VIH200V4Recalls & reported problems

Kaz USA, Inc. · VICKS STEAM INHALER FAST STEAM · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00328785012835), received between Jan 2, 2025 and Oct 8, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Human-Device Interface Problem2
  • Patient Device Interaction Problem2
  • Use of Device Problem2
  • Device Handling Problem1

Patient problems

  • Burn(s)1
  • Partial thickness (Second Degree) Burn1

Recent adverse event reports

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

  • InjuryOct 8, 2025Use of Device Problem; Human-Device Interface Problem; Device Handling Problem; Patient Device Interaction Problem; Use of Device Problem; Human-Device Interface Problem; Device Handling Problem; Patient Device Interaction Problem

    A CONSUMER REPORTED THAT WHILE USING A VICKS STEAM INHALER (MODEL VIH200C), THE DEVICE ALLEGEDLY OPENED UNEXPECTEDLY DESPITE BEING PROPERLY LOCKED, CAUSING HOT WATER TO SPILL ONTO THEIR SISTER'S CHEST AND STOMACH AND ONTO THE CONSUMER'S RIGHT HAND. THE SISTER ALLEGEDLY SUSTAINED BURNS AND BLISTERING, WHILE THE CONSUMER REPORTED BURNS TO ALL FINGERS, WHICH BECAME BLACK AND SWOLLEN. BOTH INDIVIDUALS REPORTEDLY SOUGHT EMERGENCY MEDICAL TREATMENT AND RECEIVED BURN CARE, MEDICATION, AND FOLLOW-UP. THE INCIDENT ALLEGEDLY AGGRAVATED THE SISTER'S PRE-EXISTING BREATHING CONDITION AND CAUSED EMOTIONAL DISTRESS FOR BOTH PARTIES. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "CAUTION: NEVER MOVE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN OR TIPPED OVER CAUSING INJURY OR BURNS", "DO NOT MOVE, LIFT, SHAKE, TILT OR DISASSEMBLE WHILE IN OPERATION OR IF IT STILL CONTAINS HOT WATER", AS WELL AS "ALLOW THE APPLIANCE TO COOL FOR AT LEAST 20 MINUTES BEFORE MOVING OR REFILLING IT".

    Patient problems: Burn(s)

    MAUDE report 23244180 ↗
  • InjuryJan 2, 2025Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem; Use of Device Problem; Human-Device Interface Problem; Patient Device Interaction Problem

    A CONSUMER REPORTED THAT SHE RECEIVED SECOND DEGREE BURNS ON HER LAP FROM HOT WATER THAT SPILLED FROM THE PERSONAL STEAM INHALER. SHE STATED THAT THE TOP OF THE UNIT WAS NOT LOCKED SECURELY WHILE SHE WAS USING THE PRODUCT, AND SHE PICKED IT UP CAUSING HOT WATER TO SPILL OUT OF THE UNIT, RESULTING IN HER INJURIES. MEDICAL INTERVENTION WAS SOUGHT. THE INJURY RESULTED IN AN INFECTION DESPITE HER BEST EFFORTS TO CARE FOR IT. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS THAT STATE "THE APPLIANCE SHOULD ALWAYS BE PLACED ON A FIRM, FLAT, WATERPROOF AND HEAT RESISTANT SURFACE. BE SURE THE APPLIANCE IS IN A STABLE POSITION AND THE POWER CORD IS OUT OF THE WAY TO PREVENT THE APPLIANCE FROM BEING OVERTURNED.", AS WELL AS, "CAUTION: NEVER MOVE OR DISASSEMBLE THE APPLIANCE WHILE IN USE. IT CAN SPILL HOT WATER IF TILTED, SHAKEN, OR OVERTURNED WHICH MAY LEAD TO INJURY OR BURNS." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Patient problems: Partial thickness (Second Degree) Burn

    MAUDE report 21056781 ↗

Other Humidifier, Non-Direct Patient Interface (Home-Use) devices

All Humidifier, Non-Direct Patient Interface (Home-Use) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.