Skip to content

Vicks VUL565V3Recalls & reported problems

Kaz USA, Inc. · 1.2 GALLON ULTRASONIC · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00328785014464), received between Jan 1, 2026 and Jan 1, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

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: 0 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: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 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

  • Insufficient Device Problem Information1

Patient problems

  • Cough1
  • Discomfort1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 1, 2026Insufficient Device Problem Information

    A CONSUMER REPORTED THAT SHE AND HER 3 YEAR OLD DAUGHTER HAD BEEN USING VICKS VAPOPADS (VSP30FP) WITH THE VUL565 DEVICE APPROXIMATELY 3-4 MONTHS AGO. SHE STATED THAT BOTH EXPERIENCED SIGNIFICANT RESPIRATORY HARM, INCLUDING PERSISTENT COUGHING, THROAT IRRITATION, AND NIGHTTIME BREATHING DIFFICULTY, WHICH REQUIRED REPEATED MEDICAL VISITS, PRESCRIPTION MEDICATIONS, AND INHALATION THERAPY. THE CONSUMER ALLEGES THAT THE USE OF VAPOPADS CONTRIBUTED TO THEIR RESPIRATORY ISSUES AND PROVIDED INFORMATION THAT THEY WERE PRESCRIBED ALBUTEROL INHALER, ALBUTEROL NEBULIZER TREATMENTS, FLUTICASONE (INHALED CORTICOSTEROID), OPTICHAMBER PEDIATRIC MASK, AND BENZONATATE FOR PERSISTENT COUGH. THE CONSUMER DID NOT PROVIDE AN EXACT INCIDENT DATE OF ILLNESS OR DOCTOR'S VISITS. THE CONSUMER FURTHER REPORTED THAT SYMPTOMS IMPROVED ONLY AFTER DISCONTINUATION OF BOTH THE HUMIDIFIER AND THE VAPOPADS. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Patient problems: Cough; Discomfort

    MAUDE report 23939718 ↗

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.