Draeger, Inc. recalled 431 units of the Vapor 2000 anesthetic vaporizer on November 24, 2025. A component of the devices contained impurities and did not meet specifications, posing a high hazard risk. Healthcare providers and patients should cease use immediately and follow recall instructions.
A certain component of affected devices was not delivered within specification and contained impurities.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Draeger, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Draeger Vapor 2000 anesthetic vaporizer, Model No. M35054. Units were distributed worldwide, including multiple U.S. states such as California and Texas. The recall affects 431 units.
The recall stems from a component of the vaporizer that failed to meet specifications and contained impurities. This defect poses a significant health risk to patients undergoing anesthesia.
No specific injuries or incidents have been reported in connection with this recall. The FDA classified this recall as Class I, indicating a high risk to health.
Patients and healthcare providers should stop using the Draeger Vapor 2000 immediately. Contact Draeger, Inc. or your healthcare provider for further instructions and follow the recall process outlined in the notification letter.
For more information, contact Draeger, Inc. at their official website or refer to the recall notification letter. Additional details can be found on the FDA website.
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