Draeger recalled 223 Atlan A350XL anesthesia workstations on September 9, 2025. The devices may fail during mechanical ventilation, posing serious health risks. The recall affects states across the U.S. and several countries worldwide.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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
The recalled Atlan A350XL anesthesia workstation has model number 8621600. It was distributed in the U.S. states of AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI.
The anesthesia workstation may experience a failure of the piston ventilator before use or during mechanical ventilation. This defect could endanger patients relying on the device for anesthesia and ventilation.
There are no specific incident counts or injury reports mentioned. However, the nature of the malfunction poses a high risk of serious health consequences.
Stop using the Atlan A350XL anesthesia workstation immediately. Follow the recall instructions provided by Draeger and contact your healthcare provider for further guidance.
For more information, contact Draeger, Inc. or visit their website. Details about the recall can be found at the FDA's official page.
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