FDA Device recall Z-0590-2026
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the pati…
- FDA Device
- Class I
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class I recall of ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the pati… by Draeger, citing multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0590-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-11-10 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Draeger |
| Distribution | CA, FL, IL, NY, OH, OK, PA, SC, TX, WI |
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.
Identifiers
| code_info | Model/Catalog Number: MP01840; UDI Number:04048675420736; Lot numbers: All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0590-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.