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ErgoStar CM 45 recallZ-0591-2026 · Draeger, Inc. · initiated Nov 10, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Draeger, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

On November 10, 2025, Urgent Medical Device Recall letters were sent to customers. Necessary Action: Identify if you have any affected product. Do not use any unused ErgoStar CM 40/CM 45/CM 55/CM 60 in your stock. Unused stock should be removed and returned to Draeger. Draeger recommends the alternative product MP01850 ErgoStar CM 50 as a suitable replacement. Please ensure that all potential users in your facility are made aware of this Urgent Medical Device Recall Notice and the information contained herein. If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall notification.

Recall details

Recall number
Z-0591-2026
Status
Open, Classified
Initiated by the company
Nov 10, 2025
Posted by the FDA
Dec 8, 2025
Recalling firm
Draeger, Inc.
Quantity
191470 units
Product code
BZA
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.

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97923).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page