Recall Z-0593-2026— Draeger, Inc.
Class I · Ongoing
Class I FDA medical device recall by Draeger, Inc., initiated 2025-11-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts..
- Recalling firm
- Draeger, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-11-10
- Firm location
- Telford, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.