ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respira...
FDA Recall #Z-0593-2026 — Class I — November 10, 2025
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.
Recalling Firm
Draeger, Inc. — Telford, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
2050 units
Distribution
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.
Code Information
Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated