Food, drugs, devices › Draeger, Inc.
Device recall: ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing
FDA enforcement event 97923 is a device recall by Draeger, Inc. of Telford, PA, initiated 10 Nov 2025 and classified Class I, with 4 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Draeger, Inc. has 6 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Draeger, Inc., Telford, PA.
Reason for recall
"Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0590-2026 | 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. | 14420 units | Class I | Ongoing | 17 Dec 2025 |
| Z-0591-2026 | 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. | 191470 units | Class I | Ongoing | 17 Dec 2025 |
| Z-0592-2026 | 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. | 118850 units | Class I | Ongoing | 17 Dec 2025 |
| Z-0593-2026 | 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. | 2050 units | Class I | Ongoing | 17 Dec 2025 |
Context
Other enforcement events for Draeger, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 May 2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | Device | Class I | 2 |
| 24 Nov 2025 | Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. | Device | Class I | 2 |
| 9 Sep 2025 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Descri | Device | Class I | 2 |
| 16 Jun 2025 | SafeStar 90 Plus Filter. Bidirectionally breathing system filter. | Device | Class I | 4 |
| 12 Mar 2025 | Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Prod | Device | Class I | 7 |
All 6 events for Draeger, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.