Class I — Draeger, Inc.
| Recalling firm | Draeger, Inc. |
|---|---|
| Registered facility | DRAEGER, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. |
| 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. |
| 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, T… |
| Initiated | 2025-11-10 |
| Classified | 2025-12-08 |
| Recall number | Z-0590-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Draeger, Inc. (Z-0590-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97923/
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