This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. The affected products and recommendations for what to do with the devices below have not changed.

Affected Product

The FDA is aware that Draeger, Inc. has issued a letter to affected customers recommending certain anesthesia machines be corrected prior to continued use. Affected devices:

What to Do

Until Draeger, Inc. can replace the ventilator motor assembly use these devices with close, constant supervision.

On May 7, Draeger, Inc. sent all affected customers a letter recommending the following actions:

  • Customers may continue using devices under permanent supervision until the ventilator motor assembly can be replaced
  • If the mechanical ventilation fails:
    • Use Manual/Spontaneous ventilation mode to ventilate the patient manually as needed.
    • Monitor the patient’s condition – specifically their oxygenation status as a brief cessation of ventilation can potentially lead to injury.
  • If preferred, downgrade the alarm priority of the “Ventilator error!!!” to “ALARM RESET” after switching to Manual/Spontaneous ventilation mode.
  • Make sure all users of the Draeger Atlan and others in the organization with concern for this device know about the notice.
  • Forward the notice to any third parties who may have received these products.

Reason for Correction

Draeger, Inc., is expanding their October 2024 correction to include additional Atlan A350 and A350 XL anesthesia workstations. This correction is due to a manufacturing error that may cause the piston ventilator to fail before use or mechanical ventilation to fail during use.

If the error occurs before use, such as in standby or system test mode, mechanical ventilation cannot be started. If the error occurs during a procedure, the mechanical ventilation may fail, and the device alerts the user by displaying the “Ventilator error!!!” message. Manual ventilation or spontaneous breathing remains possible in both cases. It may be necessary to manually ventilate the patient to prevent injury. With the ongoing alarm of the ventilation failure, the Atlan continues to provide the Manual/Spontaneous ventilation mode, fresh-gas and agent delivery as well as all monitoring functions without restriction.

Draeger will replace the ventilator motor assembly on affected devices. Customers will be contacted by their local Draeger Service Representative to arrange a date for the ventilator motor assembly replacement.

The use of affected product may cause serious adverse health consequences, including lack of oxygen (hypoxia), loss of the ability to expand the lungs (lung recruitment), slow heart rate (bradycardia), sudden heart stop (cardiac arrest), and death.
As of May 6, 2026, there have been no reported injuries and no reports of death.  

Device Use

The Atlan A350 and A350 XL anesthesia workstations are intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. It is used for inhaled anesthesia during surgical or diagnostic procedures.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Draeger Service Technical Support at 1-800-437-2437.

Additional FDA Resources

  1. Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure | FDA [11/19/2024]  
  2. FDA Enforcement Report – 11/2024 recall
  3. CDRH Medical Device Recalls Database – 11/2024 recall
  4. FDA Enforcement Report
  5. CDRH Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Timeline of Communication Updates

Date Actions
06/15/2026 The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.
05/15/2026 The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.