BEUDAMED
    FDA Enforcement Class I Ongoing

    ErgoStar CM 45, Model/Catalog Number: MP01845, 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.

    Recall: Z-0591-2026 · Reported December 17, 2025

    Enforcement

    Recall Number
    Z-0591-2026
    Event ID
    97923
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2025
    Initiation Date
    November 10, 2025
    Classification Date
    December 8, 2025
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    ErgoStar CM 45, Model/Catalog Number: MP01845, 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.

    Code Info

    Model/Catalog Number: MP01845; UDI Number: 04048675420729; Lot numbers: All lot numbers;

    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.

    Quantity

    191470 units