Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-0591-2026

U.S. FDA — Device Enforcement · United States · 2025-11-10 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0591-2026
Date of alert
2025-11-10
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Draeger, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04048675420729
Reported risk: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.