Atlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported
Draeger is recalling 530 Atlan A350 anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
Atlan A350 anesthesia workstations, model/catalog number 8211500, are being recalled. The Atlan is an anesthesia workstation intended for use in anesthetizing adults, paediatric patients and neonates.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
The recall covers 530 units carrying UDI-DI 04048675556176. The devices were imported from Draegerwerk AG and Co. KGaA and distributed across a list of US states including Alabama, Arizona, California and Connecticut. The FDA has classified the recall as Class I.
Hospitals operating affected serial numbers should follow Draeger's instructions and ensure a means of manual ventilation is immediately available wherever these workstations are in use.
The recalled product
- Product
- Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical vent
- Manufacturer
- Draeger, Inc.
- Affected units
- 530
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- ASTC-0006
- ASTC-0007 ASTD-0244
- ASTD-0259 ASTE-0180
- ASTE-0254
- ASTE-0255 ASTH-0083
- ASTH-0464 ASUA-0479
- ASUA-0482 ASUB-0012
- ASUB-0013
- ASUB-0015
- ASUB-0017
- ASUB-0018
- ASUB-0292 ASUC-0065
- ASUC-0084
- ASUC-0085
- ASUC-0086
- ASUC-0087
- ASUC-0088
- ASUC-0090
- ASUC-0091
- ASUC-0092
Distribution
Part of a larger recall action
This product is one of 2 recalled by Draeger, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Draeger, Inc.
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Same hazard · ventilator failure
See all →- CriticalAtlan A350XL anesthesia workstations recalled after piston ventilator failures during use
FDA (Devices) · 2025-10-08
- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
- SevereDraeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
FDA (Devices) · 2024-12-25
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
FDA (Devices) · 2024-11-20