Draeger, Inc. medical device recall: ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97923
- Recall initiated
- Nov 10, 2025
- Classified by FDA
- Dec 8, 2025
- Posted in Enforcement Report
- Dec 17, 2025
- Recalling firm
- Draeger, Inc.
- Firm location
- Telford, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 4
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Nov 10, 2025. FDA classified it 28 days later, on Dec 8, 2025. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: 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,… Draeger, Inc. has 7 recalls in our records.
Recalled products (4)
Z-0590-2026 Class I Ongoing
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
Quantity: 14420 units
Z-0591-2026 Class I Ongoing
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.
Codes / lots: Model/Catalog Number: MP01845; UDI Number: 04048675420729; Lot numbers: All lot numbers;
Quantity: 191470 units
Z-0592-2026 Class I Ongoing
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.
Codes / lots: Model/Catalog Number: MP01855; UDI Number: 04048675420705; Lot numbers: All lot numbers;
Quantity: 118850 units
Z-0593-2026 Class I Ongoing
ErgoStar CM 60, Model/Catalog Number: MP01860, 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: MP01860; UDI Number: 04048675420699; Lot numbers: All lot numbers;
Quantity: 2050 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97923
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.