Z-0591-2026Class I

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between...

Name: Z-0591-2026 ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between...
Creator: Draeger, Inc.
Published: 2025-11-10
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2025-11-10 / Open, Classified

FDA source

Draeger, Inc. began a recall of ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface... on 2025-11-10. FDA classified it as Class I and gives the reason as "Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0591-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-11-10
Posted: 2025-12-08
Recalling firm: Draeger, Inc.
Product: ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Product code: BZA Connector, Airway (Extension)
Reason for recall: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
FDA root cause: Under Investigation by firm
Action: On November 10, 2025, Urgent Medical Device Recall letters were sent to customers. Necessary Action: Identify if you have any affected product. Do not use any unused ErgoStar CM 40/CM 45/CM 55/CM 60 in your stock. Unused stock should be removed and returned to Draeger. Draeger recommends the alternative product MP01850 ErgoStar CM 50 as a suitable replacement. Please ensure that all potential users in your facility are made aware of this Urgent Medical Device Recall Notice and the information contained herein. If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall notification.
Quantity in commerce: 191470 units
Distribution: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.
Product codes and lots: Model/Catalog Number: MP01845; UDI Number: 04048675420729; Lot numbers: All lot numbers;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0591-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0590-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-08
Z-0591-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-08
Z-0592-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-08
Z-0593-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-08

Product code BZA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)