Hudson Respiratory Care Inc Concha IV Plus Heated Humidifier Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Concha IV Plus Heated Humidifier
Brand
Hudson Respiratory Care Inc
Lot Codes / Batch Numbers
All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field.
Products Sold
All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field.
Hudson Respiratory Care Inc is recalling Concha IV Plus Heated Humidifier due to Software malfunction. The humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software malfunction. The humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed in the "pause" mode.
Recommended Action
Per FDA guidance
Firm will call hospitals to arrange for a visit to update the software.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026