Draeger, Inc. recalls ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathi…

Recall date

November 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0592-2026

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 55, Model/Catalog Number: MP01855, 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.