Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. While no deaths or reported injuries are documented in this notice, the hazard involves critical life-support equipment where ventilator failure creates serious risk of patient harm.
Plain-English summary
Draeger Medical, Inc. is recalling the Atlan A300 anesthesia workstation (Model 8211300, 280 units affected). The device's piston ventilator can either be detected as failed during pre-use checks, or can suffer mechanical ventilation failure during the anesthesia procedure itself.
Ventilator failures prevent proper patient ventilation during anesthesia, creating a critical patient safety risk. Anesthesia workstations are essential life-support equipment, and ventilator failure can result in inadequate oxygen delivery and serious anesthesia complications.
The affected devices were distributed to multiple countries outside the United States, including Argentina, Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, the United Kingdom, and Vietnam. Specific serial numbers with prefixes ASTA, ASTB, ASTC, ASTD, ASTE, ASTF, ASTH, and ASTK are affected.
Healthcare facilities using the Atlan A300 should immediately verify their device serial numbers against the recall list. Affected devices should not be used until corrective action is completed. Contact Draeger Medical, Inc. for further instructions.
The recalled product
- Product
- Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 280
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)
- Model/Catalog Number: 8211300
- UDI-DI Number: 04048675556343
- Serial Numbers shipped directly from Draegerwerk AG & Co.
- KGaA to OUS: ASTA-0314
- 0315
- 0325
- 0338
- 0340
- 0384
- 0411
- 0425 ASTB-0002
- 0010
- 0018
- 0151
- 0160
- 0161
- 0165
- 0175
- 0176
- 0177
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Draeger Medical, 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 Medical, Inc.
See all →- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
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- SevereAnesthesia workstation piston ventilator may fail before or during use
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Same hazard · ventilator failure
See all →- SevereAtlan A350XL anesthesia workstations may fail during mechanical ventilation
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- SevereAtlan A350 anesthesia workstations may fail during mechanical ventilation
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- CriticalAtlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported
FDA (Devices) · 2025-10-08
- CriticalAtlan A350XL anesthesia workstations recalled after piston ventilator failures during use
FDA (Devices) · 2025-10-08
Similar recalls
- CriticalAtlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported
FDA (Devices) · 2025-10-08
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
FDA (Devices) · 2024-11-20
- CriticalAtlan A350XL anesthesia workstations recalled after piston ventilator failures during use
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- SevereAnesthesia workstation piston ventilator may fail before or during use
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- SevereAtlan A350 anesthesia workstations may fail during mechanical ventilation
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