FDA Medical devices recall ·
Atlan Product Name: Atlan A300 Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0667-2025
- Date
- (initiated October 15, 2024)
- Company / brand
- Draeger Medical, Inc.
3135 Quarry Rd, Telford, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 280 units (OUS only)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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;
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.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0667-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.