FDA Medical devices recall ·
Atlan Product Name: Atlan A350 Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0304-2025
- 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
- 1,492 units (139 units US, 1,353 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
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: 8211500; UDI-DI Number: 04048675556176; Serial Numbers Distributed in the US: ASTB-0038; 0039; 0146; 0147; 0148; 0281; 0282; 0283; 0300; 0301; 0302; 0303; 0312; 0313; 0314; 0315; 0316 ASTC-0005; 0094; 0095; 0190; 0191 ASTD-0029; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0038; 0039; 0040; 0041; 0042; 0043; 0044; 0045; 0046 0057; 0136; 0137; 0138; 0139; 0140; 0141; 0142; 0143; 0148; 0149; 0150; 0151; 0152; 0153; 0155; 0156; 0157; 0158; 0170; 0171; 0186; 0235; 0236; 0237; 0257; 0258; 0259 ASTE-0002; 0003; 0004; 0005; 0006; 0007; 0008; 0029; 0030; 0031; 0032; 0080; 0134; 0135; 0136; 0152; 0153; 0154; 0155; 0180; 0181; 0209; 0210; 0211; 0212; 0213; 0214; 0215; 0216; 0217; 0218; 0254; 0255; 0318; 0319; 0320; 0321; 0322 ASTF-0007; 0008; 0009; 0010; 0145; 0146; 0147; 0148; 0149; 0150; 0177; 0178; 0379; 0380 ASTH-0083; 0084; 0107; 0160; 0161; 0184; 0185; 0207; 0208; 0233; 0241; 0242; 0254; 0370; 0392; 0432; 0464 Serial Numbers Distributed OUS ASTA-0279; 0293; 0302; 0303; 0304; 0306; 0334; 0335; 0336; 0344; 0347; 0348; 0360; 0369; 0373; 0375; 0376; 0377; 0379; 0380; 0381; 0386; 0389; 0390; 0392; 0393; 0399; 0412; 0422; 0433; 0435; 0437; 0438 ASTB-0009; 0011; 0012; 0015; 0016; 0017; 0019; 0024; 0025; 0026; 0027; 0035; 0036; 0042; 0043; 0044; 0045; 0047; 0050; 0056; 0058; 0059; 0060; 0062; 0067; 0069; 0070; 0072; 0073; 0085; 0086; 0087; 0088; 0089; 0090; 0091; 0092; 0096; 0097; 0098; 0099; 0100; 0101; 0102; 0104; 0105; 0106; 0107; 0108; 0109; 0110; 0111; 0112;
Distribution
US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, 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, Vietnam.
States: Alabama Arizona California Florida Georgia Iowa Illinois Kentucky Massachusetts Maine North Dakota Nebraska New Hampshire New Jersey New York Ohio Pennsylvania Tennessee Texas Wisconsin Wyoming
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-0304-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.