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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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…
- 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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FDA (Devices) · 2026-10-07
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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
Similar recalls
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
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- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
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- SevereAtlan A350 anesthesia workstations may fail during mechanical ventilation
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- SevereAtlan A350XL anesthesia workstations may fail during mechanical ventilation
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- SevereAnesthesia workstation piston ventilator may fail before or during use
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