FDA Device Recall Z-0668-2025

Draeger Medical, Inc. · Telford, PA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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.

Lot / serial / GTIN: 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

Quantity: 25 units (OUS Only)

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.

Recall record

Recall number: Z-0668-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
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 initiated: 2024-10-15
Classified by FDA Center: 2024-12-18
FDA published: 2024-12-25
Recalling firm: Draeger Medical, Inc.
Firm location: Telford, PA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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