FDA announces Class I recall on anesthesia vaporizers due to risk of chemical exposure
The U.S. Food and Drug Administration (FDA) confirmed that medtech company Draegar has issued a recall on two models of its medical gas vaporizers after it was confirmed they were not manufactured up to necessary safety specifications.
According to the company, a supplier failed to ensure a certain component on its Vapor 2000 and Vapor 3000 devices were free of impurities. In this case, metal residues from solder were ineffectively cleaned off, which could cause a chemical reaction with volatile fluorinated gases. If inhaled or ingested by a patient, there could be serious risks to health, including severe irritation, lung tissue damage or pulmonary edema.
The devices are used for the enrichment of dry, fresh medical gas for patients undergoing anesthesia. Any contamination of the mixture could complicate surgeries and recovery.
No injuries have been reported. However, because the devices pose a threat to patients, the FDA has designed this recall a Class I—its most serious type.
What’s being recalled?
All devices with the following material numbers and unique device identifiers (UDIs) are impacted by this recall.
Next steps
All affected vaporizers must not be used. Per the terms of Draegar’s urgent medical device recall notice, impacted devices must be quarantined immediately. The company reached out to known customers on November 24, 2025, alerting them to the dangers associated with the Vapor 2000 and 3000s.
The company has asked that all defective devices be returned for a refund. Those seeking more information can contact Draeger at 1-800-437-2437.
To spread awareness of the recall, the FDA asks that its alert be shared. It can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.