FDA-Device2025-12-17Class IPROCESSING DEFECT
Draeger ErgoStar CM 55 airway connector recalled for cracking hose defect
What this means
Draeger's ErgoStar CM 55 airway connectors (Model MP01855) have developed cracks in the hose under use. These connectors deliver oxygen and other gases to mechanically ventilated patients. The defect affects all lot numbers of this device worldwide.
- Stop using the ErgoStar CM 55 (Model MP01855) immediately
- Contact Draeger or your medical supplier for instructions on replacement or repair
- Report any patient injuries or safety concerns to the FDA
The agency's original wording
Hazard
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
118850 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0592-2026Want us to check the next one for you?
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