Z-0592-2026 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2025
- Initiation Date
- November 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118850 units
Product Description
ErgoStar CM 55, Model/Catalog Number: MP01855, 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.
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.
Code Information
Model/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers;