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U.S. Department of Health and Human Services

Class 1 Device Recall ErgoStar

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 Class 1 Device Recall ErgoStarsee related information
Date Initiated by FirmNovember 10, 2025
Date PostedDecember 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0590-2026
Recall Event ID 97923
Product Classification Connector, airway (extension) - Product Code BZA
ProductErgoStar CM 40 Model/Catalog Number: MP01840 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 Model/Catalog Number: MP01840; UDI Number:04048675420736; Lot numbers: All lot numbers
Recalling Firm/
Manufacturer		 Draeger, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactMichael Kelhart
01-267-6641131
Manufacturer Reason
for Recall		Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce14420 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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