HIGH

Draeger Recalls Atlan A350 Anesthesia Workstation Over Ventilation Failures

Draeger recalled 530 Atlan A350 anesthesia workstations due to potential ventilation failures. The recall occurred on September 9, 2025, after reports of critical device malfunctions during use. Patients and healthcare providers must stop using the device immediately.

Quick Facts at a Glance

Recall Date
September 9, 2025
Hazard Level
HIGH
Brand
Draeger
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
Nationwide (50 states)
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

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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Product Details

The recalled model is the Atlan A350 with catalog number 8211500. The devices were imported from Draegerwerk Ag and Co. KGaA and distributed in states across the U.S. and internationally.

The Hazard

The Atlan A350 may indicate a failure of the piston ventilator before use or experience a mechanical failure during operation. These issues pose a high risk of inadequate patient ventilation.

Reported Incidents

No specific injury or incident numbers were reported. The potential failure of ventilation could lead to serious health consequences for patients.

What to Do

Stop using the Atlan A350 immediately. Follow the recall instructions provided by Draeger, Inc. Contact your healthcare provider or Draeger for further instructions.

Contact Information

Consumers can reach Draeger, Inc. for further details. Visit the official FDA website for more information on the recall.

Key Facts

  • 530 units recalled
  • Intended for adult, pediatric, and neonatal use
  • Potential ventilation malfunctions
  • Devices distributed in multiple U.S. states and countries

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
Lot Code: UDI-DI Number: 04048675556176 Serial Numbers Distributed in the US: ASTB-0181 ASTC-0005
ASTC-0006
ASTC-0007 ASTD-0244
ASTD-0259 ASTE-0180
ASTE-0254
+15 more
Affected States
Nationwide
Report Date
October 8, 2025
Recall Status
ACTIVE

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