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
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
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- VICKS V1200-6-VV1Kaz USA, Inc. · Humidifier, Non-Direct Patient Interface (Home-Use)13 reports
- Vicks VIH200V4Kaz USA, Inc. · Humidifier, Non-Direct Patient Interface (Home-Use)2 reports
- Mabis 40-741-000D-M-S Holdings, Inc. · Humidifier, Non-Direct Patient Interface (Home-Use)2 reports
- Vicks VWM845Kaz USA, Inc. · Humidifier, Non-Direct Patient Interface (Home-Use)1 death2 reports
- Walgreens 2100-WGNWalgreen CO. · Humidifier, Non-Direct Patient Interface (Home-Use)2 reports
- CVS GVP110Woonsocket Prescription Center, Incorporated · Humidifier, Non-Direct Patient Interface (Home-Use)1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.