Atlan A350XL anesthesia workstations may fail during mechanical ventilation
Atlan A350XL anesthesia workstations are being recalled because units 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 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 recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Atlan A350XL anesthesia workstation, model number 8621600, UDI-DI 04048675556183, is being recalled. The action covers 394 units, identified by the serial numbers in the recall notice.
The stated reason is that the Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. The FDA classified the action as Class I, its most serious classification.
Distribution was within the United States, in Wisconsin, Arkansas, Minnesota, Colorado, Massachusetts, Pennsylvania, Arizona, Florida, New York, South Dakota and North Dakota, and internationally. The workstations are installed in hospital operating rooms rather than sold to consumers.
Facilities should identify affected units using the model number, UDI-DI and serial numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Atlan A350XL. Model Number: 8621600. anesthesia workstation
- Manufacturer
- Draeger, Inc.
- Affected units
- 394
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 Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354
- ASSL-0357
- ASSL-0360
- ASSH-0240
- ASSH-0242
- ASSH-0243
- ASSH-0245
- ASSH-0246
- ASSH-0247
- ASSH-0248
- ASSH-0249
- ASSH-0250
- ASSL-0355
- ASSL-0356
- ASSL-0358
- ASSL-0359
- ASSL-0361
- ASSH-0239
- ASSH-0241
- ASSH-0244
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 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
- 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
Similar recalls
- CriticalAtlan A350XL anesthesia workstations recalled after piston ventilator failures during use
FDA (Devices) · 2025-10-08
- SevereAnesthesia workstation piston ventilator may fail before or during use
FDA (Devices) · 2024-11-20
- CriticalDraeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
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- CriticalAtlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported
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- 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
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