The Recall Desk

FDA (Devices) recall action 97525

Draeger, Inc. recalled 2 products on 2025-10-08

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
2025-10-08
Critical
2
Units
753

Why these products were recalled

The device 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.

States named across these recalls

1–2 of 2

  • CriticalFDA (Devices)··2025-10-08

    Atlan A350XL anesthesia workstations recalled after piston ventilator failures during use

    Draeger is recalling 223 Atlan A350XL anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.

    Product
    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ve
    Category
    Distribution
    25 states
  • CriticalFDA (Devices)··2025-10-08

    Atlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported

    Draeger is recalling 530 Atlan A350 anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical vent
    Category
    Distribution
    25 states