Draeger, Inc.
19 federal recalls on file, showing the 8 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Draeger, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-31FDA-DeviceClass ICheck your Draeger Vapor 3000 serial number
Draeger, Inc. is recalling certain Vapor 3000 anesthetic vaporizers (Model M36500) because a component inside was not built to specification and contains impurities. This affects 188 units with specific serial numbers distributed worldwide. No injuries have been reported.
- 2025-12-31FDA-DeviceClass ICheck your Draeger Vapor 2000 vaporizer serial number
Draeger, Inc. is recalling certain Vapor 2000 anesthetic vaporizers because an internal component was manufactured with impurities and did not meet quality specifications. The affected units are identified by specific serial numbers and were distributed worldwide, including across the United States.
- 2025-12-17FDA-DeviceClass IStop using Draeger ErgoStar CM 60 connectors
Draeger airway connectors (model MP01860) used in mechanical ventilation systems have developed cracks in the hose. These connectors deliver breathing gases to patients on ventilators. The cracks could potentially interrupt gas delivery.
- 2025-12-17FDA-DeviceClass IStop using Draeger ErgoStar CM 55 connectors
Draeger's ErgoStar CM 55 airway connectors (Model MP01855) have developed cracks in the hose under use. These connectors deliver oxygen and other gases to mechanically ventilated patients. The defect affects all lot numbers of this device worldwide.
- 2025-12-17FDA-DeviceClass IStop using Draeger ErgoStar CM 45 connectors
Draeger's ErgoStar CM 45 airway connectors (Model MP01845) have developed cracks in the hose in certain units. These connectors are used to deliver breathing gases to patients on mechanical ventilators. The cracks could disrupt proper airflow during critical respiratory support.
- 2025-12-17FDA-DeviceClass IStop using Draeger ErgoStar CM 40 connectors
Draeger's ErgoStar CM 40 airway connectors (model MP01840) have developed cracks in the hose during use. This connector is used in breathing systems for mechanically ventilated patients. Multiple complaints have been reported worldwide, and all lot numbers are affected.
- 2025-10-08FDA-DeviceClass IBrand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use durin
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- 2025-10-08FDA-DeviceClass IBrand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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