Respironics Remstar Pro M-Series Heated Humidifier System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Remstar Pro M-Series Heated Humidifier System.
Brand
Respironics
Lot Codes / Batch Numbers
Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109.
Products Sold
Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109.
Respironics is recalling Remstar Pro M-Series Heated Humidifier System. due to Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA.
Recommended Action
Per FDA guidance
A Service Communication dated February 5, 2009 was provided to all Respironics customers that are approved to service Respironics devices. The communication described the affected device and actions required. Further questions may be addressed by phone at 1-800-345-6443, and by email at service@respironics.com or clinical@respironics.com.
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 noticeDistribution
As reported by FDA
AZ, IN, KY, MO, NV, OH, OR, TX
Page updated: Jan 10, 2026