Draeger Atlan A300XL Anesthesia Workstation Recall: Risk of Ventilator Failure
Draeger recalls Atlan A300XL anesthesia workstations (model 8621400) due to potential piston ventilator failure before use or mechanical ventilation failure during use. Affected units have specific serial numbers.
Use caution until it’s fixed
The Atlan anesthesia workstation 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 is recalling Atlan A300XL anesthesia workstations that could fail during use, risking patient safety. This recall affects medical facilities using the equipment for anesthesia procedures. Read more at govinfonow.com/recall/53704-draeger-atlan-a300xl-anesthesia-workstation-recall-risk-of-ventilator-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/53704-draeger-atlan-a300xl-anesthesia-workstation-recall-risk-of-ventilator-failure · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0668-2025
Cite this page
“Draeger Atlan A300XL Anesthesia Workstation Recall: Risk of Ventilator Failure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53704-draeger-atlan-a300xl-anesthesia-workstation-recall-risk-of-ventilator-failure. Based on FDA recall #Z-0668-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0668-2025%22&limit=1).
Why it’s dangerous
The anesthesia workstation may indicate a failure of the piston ventilator before use or suffer mechanical ventilation failure during use. This could lead to inadequate breathing support for patients during anesthesia procedures.
Who’s affected
Healthcare facilities using the Atlan A300XL anesthesia workstation for adult, pediatric, or neonatal procedures are most at risk. The recall applies to specific serial numbers shipped from Draegerwerk AG & Co., KGaA.
How to tell if you have this one
Check for the model number 8621400 on the Atlan A300XL anesthesia workstation. Affected units have specific serial numbers listed in the recall notice, including ASTB-0051 through ASTJ-0170.
- Brand
Draeger- 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
No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0667-2025 | 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.; 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; 0178; 0179; 0180; 0181; 0182; 0214; 0215; 0218; 0232; 0233; 0234; 0235; 0236; 0248; 0249; 0250; 0262; 0263; 0264; 0265; 0266; 0276; 0277; 0278; 0279; 0280 ASTC-0008; 0025; 0036; 0037; 0038; 0039; 0040; 0041; 0042; 0046; 0047; 0048; 0049; 0050; 0062; 0063; 0064; 0077; 0078; 0079; 0080; 0081; 0089; 0090; 0091; 0092; 0093; 0102; 0103; 0104; 0123; 0124; 0125; 0126; 0127; 0133; 0139; 0140; 0150; 0151; 0152; 0153; 0154; 0169; 0176; 0177; 0178; 0179; 0182; 0183; 0184; 0185; 0186; 0187; 0192; 0195; 0196; 0200; 0201; 0202; 0203; 0242 ASTD-0028; 0051; 0052; 0080; 0081; 0082; 0083; 0084; 0085; 0086; 0087 ASTE-0012; 0013; 0014; 0015; 0041; 0042; 0043; 0044; 0063; 0064; 0065; 0084; 0176; 0177; 0178; 0179; 0243; 0244; 0282; 0299 ASTF-0005; 0006; 0019; 0027; 0028; 0029; 0048; 0049; 0050; 0072; 0073; 0074; 0075; 0082; 0093; 0110; 0111; 0162; 0166; 0167; 0197; 0198; 0220; 0221; 0222; 0301; 0406; 0434 ASTH-0001; 0002; 0003; 0024; 0025; 0041; 0042; 0043; 0044; 0097; 0098; 0099; 0115; 0116; 0117; 0118; 0149; 0150; 0151; 0152; 0153; 0195; 0196; 0197; 0198; 0220; 0221; 0222; 0227; 0228; 0229; 0230; 0257; 0258; 0259; 0260; 0261; 0274; 0275; 0276; 0277; 0297; 0298; 0299; 0304; 0305; 0328; 0329; 0355; 0356; 0357; 0393; 0394; 0395; 0396; 0407; 0408; 0409; 0410; 0423; 0424; 0425; 0426; 0427; 0428; 0445; 0446; 0447; 0448; 0449; 0465; 0466; 0467; 0468; 0469; 0470; 0484; 0485; 0486; 0487 ASTK-0033; 0034; 0035; 0062 | 280 units (OUS only) |
| Z-0668-2025 | Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.; Model/Catalog Number: 8621400; UDI-DI Number: 04048675556343; Serial Numbers shipped directly from Draegerwerk AG & Co., KGaA to OUS: ASTB-0051; 0053; 0054; 0055; 0063; 0065; 0093; 0162 ASTE-0219; 0220; 0221; 0222; 0377 ASTF-0472; 0473 ASTH-0005; 0006; 0026; 0027; 0047; 0186; 0223; 0224; 0401 ASTJ-0170 | 25 units (OUS Only) |
What to do — step by step
Check for Recalled Serial Numbers
Review the serial numbers listed in the recall notice to determine if your Atlan A300XL is affected.
Where it went and when
Where it was distributed
Distributed in Colorado, and outside the U.S.
FDA distribution: “No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado.
Recall timeline
FDA published this recall 2 months 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.
Questions people ask
What should I do if I have this product?
Check the serial numbers against the list provided in the recall notice to see if your Atlan A300XL is affected. No specific action is required if it is not on the list.
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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-0668-2025 (October 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0668-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.