Medical device recalls High risk

Draeger, Inc. recalls ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing…

Recall date
November 10, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0590-2026
FDA classification
Class I
Brand / firm
Draeger, Inc.
Sold / distributed
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…

Why it was recalled

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

ErgoStar CM 40 Model/Catalog Number: MP01840 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.

Get recall alerts

Free email alert whenever Draeger, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Draeger, Inc.