Exact FDA event identifier

Event 95759

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 15, 2024
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Draeger Medical, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-0667-2025

Recall number: Z-0667-2025
Initiated: October 15, 2024
Classification: Class I
Status: Ongoing
Recalling firm: Draeger Medical, Inc.
Quantity: 280 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 pattern

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.

device · product 2 of 2

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.

Z-0668-2025

Recall number: Z-0668-2025
Initiated: October 15, 2024
Classification: Class I
Status: Ongoing
Recalling firm: Draeger Medical, Inc.
Quantity: 25 units (OUS Only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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