Reported Oct 8, 2025 · Ongoing
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product…
Draeger, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draeger, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Brand NameAtlan
- Product NameAtlan
- A350XL Model/Catalog Number8621600
- Software VersionNot
- Applicable Product DescriptionThe Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical
- or diagnostic interventions ComponentNot applicable
- Lot codes and dates
- Lot CodeUDI-DI
- Number04048675556183
- Serial Numbers Distributed in the USASTA-0307,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, ASTH-0335,ASTH-0336,ASTH-0383,ASTH-0384 ASTJ-0014 ASUA-0469,ASUA-0483,ASUA-0484,ASUA-0486,ASUA-0488 ASUB-0093,ASUB-0169,ASUB-0170,ASUB-0171,ASUB-0172,ASUB-0173,ASUB-0174,ASUB-0175, ASUB-0176,ASUB-0183,ASUB-0184,ASUB-0185,ASUB-0186,ASUB-0187,ASUB-0215,ASUB-0216, ASUB-0217,ASUB-0218,ASUB-0219,ASUB-0221,ASUB-0222,ASUB-0250,ASUB-0251,ASUB-0266, ASUB-0267, ASUB-0268,ASUB-0269,ASUB-0270 ASUC-0067,ASUC-0068,ASUC-0069,ASUC-0072,ASUC-0114,ASUC-0115,ASUC-0146,ASUC-0148, ASUC-0149,ASUC-0150,ASUC-0151,ASUC-0153,ASUC-0155,ASUC-0156,ASUC-0157,ASUC-0158, ASUC-0174,ASUC-0175,ASUC-0176,ASUC-0178,ASUC-0179,ASUC-0180,ASUC-0181,ASUC-0182, ASUC-0183,ASUC-0184,ASUC-0185,ASUC-0186,ASUC-0187,ASUC-0188,,ASUC-0189,ASUC-0190, ASUC-0191,ASUC-0192,ASUC-0193,ASUC-0194,ASUC-0196,ASUC-0197,ASUC-0198,ASUC-0199, ASUC-0200,ASUC-0201,ASUC-0202,ASUC-0211,ASUC-0212,ASUC-0213,ASUC-0214,ASUC-0215, ASUC-0216,ASUC-0217,ASUC-0238,ASUC-0239,ASUC-0285,ASUC-0368,ASUC-0369,ASUC-0370, ASUC-0371,ASUC-0372,ASUC-0373 ASUD-0142,ASUD-0142,ASUD-0143,ASUD-0143,ASUD-0144,ASUD-0145,ASUD-0146,ASUD-0147, ASUD-0164,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0187,ASUD-0188,ASUD-0189, ASUD-0190,ASUD-0191,ASUD-0192,ASUD-0193,ASUD-0207,ASUD-0208,ASUD-0209,ASUD-0210, ASUD-0211,ASUD-0212,ASUD-0212,ASUD-0275,ASUD-0276,ASUD-0277,ASUD-0294 Serial Numbers Distributed OUS (Direct shipped from Draegerwerk AG & Co
- KGaA)
70 of 70 codes
ASUB-0094ASUB-0279ASUB-0280ASUB-0281ASUB-0282ASUB-0284ASUB-0285ASUB-0286ASUC-0005ASUC-0006ASUC-0007ASUC-0008ASUC-0010ASUC-0011ASUC-0012ASUC-0013ASUC-0014ASU-0042ASUC-0043ASUC-0044ASUC-0045ASUC-0046ASUC-0047ASUC-0048ASUC-0049ASUC-0050ASUC-0051ASUC-0052ASUC-0053ASUC-0054ASUC-0057ASUC-0060ASUC-0073ASUC-0074ASUC-0075ASUC-0076ASUC-0077ASUC-0078ASUC-0079ASUC-0080SUC-0081ASUC-0082ASUC-0331ASUC-0377ASUC-0378ASUC-0379ASUD-0067ASUD-0068ASUD-0088ASUD-0089ASUD-0091ASUD-0092ASUD-0093ASUD-0094ASUD-0095ASUD-0096ASUD-0097ASUD-0112ASUD-0113ASUD-0114
- Amount recalled
- 223
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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