PlainRecalls
FDA Devices Critical Class I Ongoing

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.

Reported: December 17, 2025 Initiated: November 10, 2025 #Z-0593-2026

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.

Reason for Recall

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

Details

Recalling Firm
Draeger, Inc.
Units Affected
2050 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.
Location
Telford, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Draeger, Inc.. Units affected: 2050 units.
Why was this product recalled?
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 17, 2025. Severity: Critical. Recall number: Z-0593-2026.