Recall Z-0590-2026
Draeger, Inc. · initiated November 10, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
ErgoStar 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.
Codes / lots: Model/Catalog Number: MP01840; UDI Number:04048675420736; Lot numbers: All lot numbers
Reason for recall
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0590-2026
- Initiated
- November 10, 2025
- Posted by FDA
- December 8, 2025
- Product code
- BZA – Connector, Airway (Extension)
- Quantity
- 14420 units
- 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…
- Recalling firm
- Draeger, Inc., Telford, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0591-2026 Class I | ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | 11/10/2025Open, Classified |
| Z-0592-2026 Class I | ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | 11/10/2025Open, Classified |
| Z-0593-2026 Class I | ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | 11/10/2025Open, Classified |