Draeger, Inc. recalls ErgoStar CM 55

Recalling company

Draeger, Inc.

Product

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.

Reason

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

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Nov 10, 2025

Reported

Dec 17, 2025

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.

Status

Ongoing

Quantity

118850 units

Lot / codes

Model/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers;

Company location

Telford, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-0592-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0592-2026 in the FDA Enforcement Report. Also see FDA recall press releases.