FDA Device Intelligence
HomeDevice types › KFZ

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

FDA product code KFZ · Class 1 · Anesthesiology

358
Registered devices
801
Adverse events
3
Recalls
20
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2021-03-16Cardinal Health Inc.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 in
2015-11-20Bigwall Enterprises"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 i
2003-04-15KAZ Inc.Humidifiers may overheat.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.