Atlan A350XL anesthesia workstations recalled after piston ventilator failures during use
Draeger is recalling 223 Atlan A350XL 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 A350XL anesthesia workstations, model/catalog number 8621600, are being recalled. The Atlan is an anesthesia workstation intended for use in anesthetizing adults, paediatric patients and neonates, and supports mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing and spontaneous breathing during surgical or diagnostic interventions.
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 223 units carrying UDI-DI 04048675556183. The devices were imported from Draegerwerk AG and Co. KGaA and distributed to Alabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia and Wisconsin, with additional direct shipments to other countries. 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 A350XL Model/Catalog Number: 8621600 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
- 223
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)
- ASTA-0309
- ASTA-0311
- ASTA-0349
- ASTA-0350
- ASTA-0409 ASTB-0048 ASTC-0244
- ASTC-0245 ASTD-0008
- ASTD-0009
- ASTD-0010
- ASTD-0011
- ASTD-0013
- ASTD-0014
- ASTD-0212
- ASTD-0239 ASTH-0307
- ASTH-0308
- ASTH-0309
- ASTH-0310
- ASTH-0311
- ASTH-0332
- ASTH-0333
- ASTH-0334
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.
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- 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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- CriticalVapor 3000 anesthetic vaporizers recalled over an out of specification component
FDA (Devices) · 2025-12-31
- CriticalVapor 2000 anesthetic vaporizers recalled over an out of specification component
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Same hazard · ventilator failure
See all →- CriticalAtlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported
FDA (Devices) · 2025-10-08
- SevereDraeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall
FDA (Devices) · 2024-12-25
- SevereFDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure
FDA (Devices) · 2024-12-25
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
FDA (Devices) · 2024-11-20
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
Similar recalls
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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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- SevereAtlan A350 anesthesia workstations may fail during mechanical ventilation
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