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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Draeger Medical, Inc.
Reason for Recall:
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

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; 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

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0667-2025

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