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Recall Observatory FDA recall evidence

Device 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.

Z-0593-2026

November 10, 2025

Class I

Product summary

Firm
Draeger, Inc.
Event
Event 97923
Status
Ongoing
Classification
Class I
Quantity
2050 units
Official record key
device-enforcement:Z-0593-2026

Official wording

Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Code information: Model/Catalog Number: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.