Draeger, Inc. — 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 t
⚠️ Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Is this relevant to me?
- Geography
- US, CA, FL, IL, NY, OH, OK, PA, SC, TX, WI
- Source agency
- FDA
- Category
- Health
- Published
- November 10, 2025
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.
What's affected?
- Product
- 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.
- Brand
- Draeger, Inc.
- Lot code
- All
Additional details
Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 2050 units.
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