FDA-Device2025-12-17Class IPROCESSING DEFECT
Draeger ErgoStar CM 40 airway connector recalled for cracking hose defect
Stop using Draeger ErgoStar CM 40 connectors
Draeger's ErgoStar CM 40 airway connectors (model MP01840) have developed cracks in the hose during use. This connector is used in breathing systems for mechanically ventilated patients. Multiple complaints have been reported worldwide, and all lot numbers are affected.
- Stop using the Draeger ErgoStar CM 40 (model MP01840) immediately if you have one
- Check your facility's inventory for affected units using lot number information
- Contact Draeger for replacement or guidance on safe alternatives
- Report any patient incidents or equipment failures to your biomedical team and the FDA
Hazard
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
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
14420 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
ErgoStar CM 40 Model/Catalog Number: MP01840 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-0590-2026Don't want to check this manually?
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