Draeger, Inc.: Device Recall

Recall #Z-0593-2026 · 11/10/2025

Class I: Dangerous

Recall Details

Recall Number
Z-0593-2026
Classification
Class I
Product Type
Device
Recalling Firm
Draeger, Inc.
Status
Ongoing
Date Initiated
11/10/2025
Location
Telford, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2050 units

Reason for Recall

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

Product Description

ErgoStar CM 60, Model/Catalog Number: MP01860, 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.

Distribution Pattern

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.

Other Recalls by Draeger, Inc.

View all recalls by Draeger, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.