Atlan A350 Anesthesia Workstation Recall: Risk of Ventilation Failure
Draeger Inc. recalls Atlan A350 anesthesia workstations with model 8211500 due to potential piston ventilator failure before use or mechanical ventilation failure during use.
Use caution until it’s fixed
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Contact the company
What happened, in plain English
Draeger Inc. is recalling Atlan A350 anesthesia workstations with model number 8211500 because they may fail to properly ventilate patients during use or before use. This could lead to inadequate anesthesia or breathing support for patients. Read more at govinfonow.com/recall/51367-atlan-a350-anesthesia-workstation-recall-risk-of-ventilation-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/51367-atlan-a350-anesthesia-workstation-recall-risk-of-ventilation-failure · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2616-2025
Cite this page
“Atlan A350 Anesthesia Workstation Recall: Risk of Ventilation Failure.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51367-atlan-a350-anesthesia-workstation-recall-risk-of-ventilation-failure. Based on FDA recall #Z-2616-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2616-2025%22&limit=1).
Why it’s dangerous
The device may indicate a failure of the piston ventilator before use or suffer a mechanical ventilation failure during use. This could result in inadequate anesthesia delivery or improper patient ventilation, potentially causing harm to patients.
Who’s affected
Healthcare professionals using the Atlan A350 anesthesia workstation for patient ventilation in hospitals or clinics. Patients receiving anesthesia during surgery or procedures are at risk if the device fails.
How to tell if you have this one
Check for model number 8211500 on the Atlan A350 anesthesia workstation. Serial numbers distributed in the US include a list of specific codes starting with ASTB, ASTC, ASTD, ASTE, ASTH, ASUA, ASUB, ASUC, ASUD.
- Brand
Atlan- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Belgium, Brazil, Chili, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2616-2025 | 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 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 Component: Not applicable; Lot Code: UDI-DI Number: 04048675556176 Serial Numbers Distributed in the US: ASTB-0181 ASTC-0005,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,ASUC-0096,ASUC-0097,ASUC-0099,ASUC-0100,ASUC-0101,ASUC-0102,ASUC-0103, ASUC-0104,ASUC-0105,ASUC-0107,ASUC-0108,ASUC-0109,ASUC-0110,ASUC-0111,ASUC-0112, ASUC-0113,ASUC-0116,ASUC-0117,ASUC-0118,ASUC-0119,ASUC-0120,ASUC-0121,ASUC-0122, ASUC-0123,ASUC-0125,ASUC-0126,ASUC-0127,ASUC-0128,ASUC-0129,ASUC-0130,ASUC-0131, ASUC-0132,ASUC-0133,ASUC-0134,ASUC-0135,ASUC-0136,ASUC-0137,ASUC-0138,ASUC-0139, ASUC-0140,ASUC-0141,ASUC-0142,ASUC-0143,ASUC-0143,ASUC-0144,ASUC-0145,ASUC-0162, ASUC-0163,ASUC-0164,ASUC-0165,ASUC-0166,ASUC-0167,ASUC-0168,ASUC-0169,ASUC-0170, ASUC-0171,ASUC-0172,ASUC-0173,ASUC-0203,ASUC-0204,ASUC-0205,ASUC-0206,ASUC-0207, ASUC-0208,ASUC-0209,ASUC-0210,ASUC-0218,ASUC-0219,ASUC-0220,ASUC-0221,ASUC-0222, ASUC-0223,ASUC-0224,ASUC-0225,ASUC-0235,ASUC-0236,ASUC-0237,ASUC-0340,ASUC-0341 ASUD-0244,ASUD-0261,ASUD-0262,ASUD-0263,ASUD-0267,ASUD-0281,ASUD-0282,ASUD-0283 Serial Numbers Distributed OUS ASUA-0353,ASUA-0441,ASUA-0447,ASUA-0472,ASUA-0478,ASUA-0496,,SUA-0497,ASUA-0500, ASUB-0004,ASUB-0024,ASUB-0025,ASUB-0030,ASUB-0033,ASUB-0034,ASUB-0035,ASUB-0038, ASUB-0039,ASUB-0040,ASUB-0041,ASUB-0043,ASUB-0044,ASUB-0046,ASUB-0048,ASUB-0063, ASUB-0064,ASUB-0066,ASUB-0067,ASUB-0069,ASUB-0073,ASUB-0074,ASUB-0075,ASUB-0076, ASUB-0077,ASUB-0095,ASUB-0096,ASUB-0097,ASUB-0098,ASUB-0099,ASUB-0100,ASUB-0101, ASUB-0102,ASUB-0104,ASUB-0105,ASUB-0107,ASUB-0108,ASUB-0109,ASUB-0112,ASUB-0113, ASUB-0114,ASUB-0115,ASUB-0116,ASUB-0118,ASUB-0120,ASUB-0121,ASUB-0122,ASUB-0123, ASUB-0124,ASUB-0128,ASUB-0129,ASUB-0130,ASUB-0136,ASUB-0137,ASUB-0139,ASUB-0140, ASUB-0141,ASUB-0143,ASUB-0144,ASUB-0145,ASUB-0146,ASUB-0147,ASUB-0148,ASUB-0149, ASUB-0150,ASUB-0151,ASUB-0152,ASUB-0153,ASUB-0154,ASUB-0155,ASUB-0156,ASUB-0157, ASUB-0158,ASUB-0159,ASUB-0160,ASUB-0161,ASUB-0162,ASUB-0163,ASUB-0177,ASUB-0178, ASUB-0188,ASUB-0189,ASUB-0190,ASUB-0191,ASUB-0192,ASUB-0193,ASUB-0194,ASUB-0195, ASUB-0196,ASUB-0197,ASUB-0198,ASUB-0199,ASUB-0201,ASUB-0202,ASUB-0203,ASUB-0204, ASUB-0205,ASUB-0206,ASUB-0207,ASUB-0208,ASUB-0209,ASUB-0210,ASUB-0211,ASUB-0223, ASUB-0224,ASUB-0225,ASUB-0226,ASUB-0227,ASUB-0229,ASUB-0230,ASUB-0231,ASUB-0232, ASUB-0233,ASUB-0234,ASUB-0235,ASUB-0236,ASUB-0237,ASUB-0238,ASUB-0240,ASUB-0243, ASUB-0245,ASUB-0252,ASUB-0253,ASUB-0254,ASUB-0255,ASUB-0256,ASUB-0257,ASUB-0258, ASUB-0260,ASUB-0261,ASUB-0262,ASUB-0263,ASUB-0264,ASUB-0265,ASUB-0271,ASUB-0272, ASUB-0273,ASUB-0276,ASUB-0278,ASUC-0001ASUC-0004,ASUC-0016,ASUC-0017,ASUC-0018, ASUC-0019,ASUC-0020,ASUC-0022,ASUC-0024,ASUC-0026,,ASUC-0028,,ASUC-0030,ASUC-0031, ASUC-0032,ASUC-0033,ASUC-0034,ASUC-0035,ASUC-0036,ASUC-0039,ASUC-0061,ASUC-0062, ASUC-0063,ASUC-0226,ASUC-0227,ASUC-0228,ASUC-0229,ASUC-0230,ASUC-0232,ASUC-0233, ASUC-0234,ASUC-0247,ASUC-0248,ASUC-0249,ASUC-0250,ASUC-0251,ASUC-0252,ASUC-0253, ASUC-0254,ASUC-0255,ASUC-0256,ASUC-0257,ASUC-0262,ASUC-0263,ASUC-0264,ASUC-0265, ASUC-0266,ASUC-0267,ASUC-0269,ASUC-0272,ASUC-0273,ASUC-0274,ASUC-0275,ASUC-0276, ASUC-0277,ASUC-0278,ASUC-0279,ASUC-0284,ASUC-0286,ASUC-0287,ASUC-0288,ASUC-0289, ASUC-0290,ASUC-0291,ASUC-0292,ASUC-0293,ASUC-0294,ASUC-0295,ASUC-0296,ASUC-0300, ASUC-0301,ASUC-0302,ASUC-0303,ASUC-0304,ASUC-0305,ASUC-0306ASUC-0307,ASUC-0308, ASUC-0309,ASUC-0310,ASUC-0311,ASUC-0314,ASUC-0315,ASUC-0316,ASUC-0319,ASUC-0320, ASUC-0321,ASUC-0322,ASUC-0323,ASUC-0339,ASUC-0342,ASUC-0343,ASUC-0344,ASUC-0345, ASUC-0346,ASUC-0348,ASUC-0349,ASUC-0350,ASUC-0351,ASUC-0352,ASUC-0353,ASUC-0354, ASUC-0355,ASUC-0356,ASUC-0357,ASUC-0358,ASUC-0359,ASUC-0360,ASUC-0361,ASUC-0362, ASUC-0363,ASUC-0364,ASUC-0365,ASUC-0366,ASUC-0367,ASUC-0380,ASUC-0381,ASUC-0382, ASUC-0383,ASUC-0384,ASUC-0385,ASUC-0386,ASUC-0387,ASUC-0391,ASUC-0392,ASUC-0393, ASUC-0394,ASUC-0395,ASUC-0396,ASUC-0397,ASUC-0398,ASUC-0399,ASUC-0400,ASUC-0401, ASUC-0402,ASUC-0403,ASUC-0404,ASUC-0405,ASUC-0406,ASUC-0407,ASUC-0408,ASUC-0409, ASUC-0410,ASUC-0416,ASUD-0001,ASUD-0002,ASUD-0004,ASUD-0005,ASUD-0006,ASUD-0007, ASUD-0008,ASUD-0009,ASUD-0010,ASUD-0011,ASUD-0012,ASUD-0013,ASUD-0014,ASUD-0015, ASUD-0016,ASUD-0018,ASUD-0019,ASUD-0020,ASUD-0022,ASUD-0023,ASUD-0041,ASUD-0042, ASUD-0043,ASUD-0044,ASUD-0046,ASUD-0047,ASUD-0048,ASUD-0049,ASUD-0050,ASUD-0051, ASUD-0057,ASUD-0059,ASUD-0060,ASUD-0061,ASUD-0062,ASUD-0063,ASUD-0064,ASUD-0065, ASUD-0066,ASUD-0074,ASUD-0075,ASUD-0077,ASUD-0078,ASUD-0079,ASUD-0080,ASUD-0081, ASUD-0098,ASUD-0099,ASUD-0100,ASUD-0101,ASUD-0102,ASUD-0103,ASUD-0104,ASUD-0105, ASUD-0106,ASUD-0107,ASUD-0108,ASUD-0109,ASUD-0126,ASUD-0127,ASUD-0128,ASUD-0129, ASUD-0130,ASUD-0131,ASUD-0133,ASUD-0135,ASUD-0136,ASUD-0140,ASUD-0141,ASUD-0150, ASUD-0168,ASUD-0173,ASUD-0174,ASUD-0175,ASUD-0181,ASUD-0182,ASUD-0183,ASUD-0184, ASUD-0185,ASUD-0186,ASUD-0196,ASUD-0198,ASUD-0199,ASUD-0200,ASUD-0201,ASUD-0202, ASUD-0203,ASUD-0204,ASUD-0205,ASUD-0206,ASUD-0219,ASUD-0220,ASUD-0221,ASUD-0222, ASUD-0223,ASUD-0224,ASUD-0225,ASUD-0226,ASUD-0227,ASUD-0228,ASUD-0238,ASUD-0239, ASUD-0245,ASUD-0246,ASUD-0247,ASUD-0248,ASUD-0249,ASUD-0250,ASUD-0251,ASUD-0252, ASUD-0253,ASUD-0258,ASUD-0259,ASUD-0260,ASUD-0273,ASUD-0274 | 530 |
| Z-2617-2025 | 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 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 Component: Not applicable; Lot Code: UDI-DI Number: 04048675556183 Serial Numbers Distributed in the US: ASTA-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): ASUB-0094,ASUB-0279,ASUB-0280,ASUB-0281,ASUB-0282,ASUB-0284,ASUB-0285,ASUB-0286, ASUC-0005,ASUC-0006,ASUC-0007,ASUC-0008,ASUC-0010,ASUC-0011,ASUC-0012,ASUC-0013, ASUC-0014,ASU-0042,ASUC-0043,ASUC-0044,ASUC-0045,ASUC-0046,ASUC-0047,ASUC-0048, ASUC-0049,ASUC-0050,ASUC-0051,ASUC-0052,ASUC-0053,ASUC-0054,ASUC-0057,ASUC-0060, ASUC-0073,ASUC-0074,ASUC-0075,ASUC-0076,ASUC-0077,ASUC-0078,ASUC-0079,ASUC-0080, SUC-0081,ASUC-0082,ASUC-0331,ASUC-0377,ASUC-0378,ASUC-0379,ASUD-0067,ASUD-0068, ASUD-0088,ASUD-0089,ASUD-0091,ASUD-0092,ASUD-0093,ASUD-0094,ASUD-0095,ASUD-0096, ASUD-0097,ASUD-0112,ASUD-0113,ASUD-0114,ASUD-0115,ASUD-0116,ASUD-0117,ASUD-0118, ASUD-0119,ASUD-0120,ASUD-0121,ASUD-0122,ASUD-0160,ASUD-0166 | 223 |
What to do — step by step
Check Device Status
Verify if your Atlan A350 has model number 8211500 by checking the serial number on the device.
Where it went and when
Where it was distributed
Distributed in 26 states, and outside the U.S.
FDA distribution: “Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Devices were direct shipped from…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, Nebraska, Nevada, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Texas, Utah, Virginia, Wisconsin.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2616-2025 (September 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2616-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.