High risk Medical DevicesClass I

Draeger Atlan A350XL Anesthesia Workstation Recall

Atlan A350XL. Model Number: 8621600. anesthesia workstation

Updated May 7, 2026

Draeger has recalled the Atlan A350XL anesthesia workstation (model 8621600) because the device may signal a piston ventilator failure before use, or the mechanical ventilation may fail during use. A ventilator failure during an anesthesia procedure is a life-threatening risk to patients.

Is the Draeger, Inc. recalled? Yes. This product was recalled by FDA on May 7, 2026. Details below.

What is recalled

Draeger Atlan A350XL anesthesia workstation, model number 8621600.

Am I affected

You are affected if your facility uses a Draeger Atlan A350XL anesthesia workstation with model number 8621600. Check the device label or documentation for the model number to confirm.

What to do right now

Stop using any affected unit and contact Draeger, Inc. directly for guidance on next steps. Because no consumer contact details were included in this recall notice, visit the FDA recall page at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts for the latest information, or reach out to your Draeger sales or service representative.

The hazard

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2208-2026
Classification
Class I
Recalled
May 7, 2026
Read the official notice

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