Z-1260-2009

Remstar Pro M-Series Heated Humidifier System

Name: Z-1260-2009 Remstar Pro M-Series Heated Humidifier System
Creator: Respironics
Published: 2009-02-05
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2009-02-05 / Terminated / root cause: manufacturing process

FDA source

Respironics began a recall of Remstar Pro M-Series Heated Humidifier System on 2009-02-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1260-2009
Status: Terminated
Initiated: 2009-02-05
Posted: 2009-06-17
Terminated: 2012-07-05
Recalling firm: Respironics, Inc.
Product: Remstar Pro M-Series Heated Humidifier System.
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected] or [email protected].
Quantity in commerce: 449,585 units
Distribution: Worldwide Distribution -- US including states of OR, OH, KY, TX, MO, AZ, IN and NV and countries of United Arab Emirates, Bosnia, Belgium, Bulgaria, Bahrain, Canada, Czech Republic, Denmark, Egypt, Spain, Finland, Greece, Croatia, Hungary, Ireland, Israel, Jordan, Kuwait, Lebanon, Latvia, Macedonia, Netherlands, Norway, Oman, Poland, Portugal, Romania, Qatar, Russia, Slovenia, Turkey, Serbia and South Africa.
Product codes and lots: Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109.

Product code BZD

K072996Class IIRemstar Pro M-Series CPAP & Heated Humidifier SystemRespironics, Inc. / cleared 2007-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)