The Recall Desk

FDA (Devices) recall action 95759

Draeger Medical, Inc. recalled 2 products on 2024-12-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-12-25
Critical
0
Units
305

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2024-12-25

    Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall

    Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2024-12-25

    FDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure

    Draeger Medical recalls the Atlan A300XL anesthesia workstation for potential piston ventilator failure that could occur before use or during anesthesia delivery. Twenty-five units were distributed outside the United States.

    Product
    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.
    Category
    Distribution
    0 states