Humidifier, Non-direct Patient Interface (home-use)
Anesthesiology · 21 CFR 868.5460
Recent MDR events
801 adverse event reports on file
- HoneywellJul 27, 2026InjuryKaz Usa, Inc., A Helen Of Troy Company1314800-2026-00015
- VICKSJun 19, 2026InjuryKaz Usa, Inc., A Helen Of Troy Company1314800-2026-00010
- Mabis Steam InhalerApr 30, 2026MalfunctionVega Technologies Inc.3003188183-2026-00000
- SUNBEAMMar 12, 2026MalfunctionSunbeam Products, Inc.3010341502-2026-00004
- VICKSFeb 14, 2026InjuryKaz Usa, Inc., A Helen Of Troy Company1314800-2026-00004
- MABIS STEAM INHALERJan 20, 2026Malfunction3003188183-2026-00001
- VICKSJan 1, 2026InjuryKaz Usa, Inc., A Helen Of Troy Company1314800-2026-00001
- MABIS STEAM INHALERDec 22, 2025InjuryVega Technologies1000143485-2025-28077
- VICKSOct 31, 2025InjuryKaz Usa, Inc., A Helen Of Troy Company1314800-2025-00028
- VICKSOct 8, 2025InjuryKaz Usa, Inc., A Helen Of Troy Company1314800-2025-00026
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- KAZ Inc.TerminatedMay 8, 2003
Vicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief of Cold and Flu Symptoms'' sold over the counter. Firm on the label:
Humidifiers may overheat.
Z-0790-03 · View FDA record ↗ - Bigwall EnterprisesTerminatedUnknown
WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks"
"The public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investigated and remain unconfirmed. No causal connection between the complaints and the producta"s proper use as instructed have been determined."
Z-0698-2016 · View FDA record ↗ - Cardinal Health Inc.Open, ClassifiedUnknown
VAPORIZER VICKS 1.5GAL
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Z-1935-2021 · View FDA record ↗
Registered firms
122 firms currently registered for this product code
Tri-tech Medical, Inc.
AVON, OH, US
Evereast Medical Products Group Co., Ltd
Changyuan City Henan, CN
A Power Inst., Inc.
Taichung City, TW
Xiamen Bri Environmental Industry Co.,ltd
Xiamen Fujian, CN
Kaz Usa, Inc., A Helen Of Troy Company
MARLBOROUGH, MA, US
Shenzhen Xiazhifeng Electronic Co., Ltd
Shenzhen Guangdong, CN
Foshan Gaunying Electronics Co., Ltd
Foshan Guangdong, CN
Helen Of Troy Macao Limited
Macau Guangdong, CN
Kuo Tong Electricaltechnology (hui Zhou) Co., Ltd.
HUIZHOU CITY Guangdong, CN
Smart Technology Co., Ltd.
Foshan Guangdong, CN
Bestway Plastic And Metal Products Ltd.
Dongguan Guangdong, CN
Allied Medical Llc
Earth City, MO, US
Shenzhen Youmay Electronics Co., Ltd
Shenzhen Guangdong, CN
Dms Holdings, Inc.,
Waukegan, IL, US
Medease Life Co.,ltd
DANYANG Jiangsu, CN
Ohio Medical Llc
Gurnee, IL, US
Vapore, Llc
Concord, CA, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Hsiner Co., Ltd.
Taichung City, TW
Bear Down Brands, Llc
Fullerton, CA, US
Kaz Usa, Inc., A Helen Of Troy Company
Olive Branch, MS, US
Westmed, Inc.
TUCSON, AZ, US
Dechang Vietnam Company Limited
Trang Bom Dong Nai, VN
510(k) clearances
20 clearances for this product code
- Kaz, Inc.Feb 10, 1995
K950116 · THERASTEAM PERSONAL STEAM INHALER
- Virotherm LaboratoryOct 22, 1992
K915603 · VIROTHERM HUMIDIFIER
- Twinmed Products, Inc.Feb 16, 1990
K894734 · RHINOTHERM ULTRA 2
- Associated Mills, Inc.Jun 15, 1987
K871661 · WH150 ROOM HUMIDIFIER
- Sunbeam Appliance Service Co.May 8, 1987
K871189 · SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380
- Transpirator Technologics, Inc.Nov 7, 1986
K862919 · TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER
- The Timeter GroupJul 14, 1986
K862171 · MP-500 ELECTRONIC NEBULIZER
- Associated Mills, Inc.Jun 5, 1986
K862042 · SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER