Draeger recalled 2,050 units of the ErgoStar CM 60 airway connector on November 10, 2025. The recall follows multiple reports of cracks in the device, posing a risk to mechanically ventilated patients. Healthcare providers and patients should stop using the connector immediately.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Draeger, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the ErgoStar CM 60, Model/Catalog Number MP01860. It connects respiratory gases between the breathing system and patient interface, such as an endotracheal tube. The product was distributed worldwide, including several U.S. states.
The airway connector can develop cracks in the hose, potentially compromising patient safety. This defect poses a high risk to patients relying on mechanical ventilation.
The recall is due to multiple complaints about the product cracking. No specific injury or death counts have been reported.
Stop using the device immediately. Contact Draeger, Inc. or your healthcare provider for further instructions and follow the recall process detailed in the notification letter.
For more information, contact Draeger, Inc. at their official website or the provided recall documentation. Additional details can be found on the FDA's enforcement report.
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