Draeger, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0591-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product 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.

Product Classification:

Class I

Date Initiated: November 10, 2025

Date Posted: December 17, 2025

Recall Number: Z-0591-2026

Event ID: 97923

Reason for Recall:

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

Status: Ongoing

Product Quantity: 191470 units

Code Information:

Model/Catalog Number: MP01845; UDI Number: 04048675420729; 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.

Voluntary or Mandated:

Voluntary: Firm initiated