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CLASS I · SeriousFDA

Draeger, Inc. recalls ErgoStar CM 40

📅 Nov 10, 2025 · 📍 CA, FL, IL, NY, OH, OK, PA, SC +2
Recalling company
Draeger, Inc.
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.
Reason
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Classification
Class I – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
Nov 10, 2025
Reported
Dec 17, 2025
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.
Status
Ongoing
Quantity
14420 units
Lot / codes
Model/Catalog Number: MP01840; UDI Number:04048675420736; Lot numbers: All lot numbers
Company location
Telford, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-0590-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0590-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.