Reported Dec 25, 2024 · Ongoing

Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation…

Draeger Medical, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042

Is this the product you have?

  • Brand NameAtlan
  • Product NameAtlan
  • A300XL Model/Catalog Number8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates
Lot codes and dates
  • Model/Catalog Number8621400
  • UDI-DI Number04048675556343; 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
Amount recalled
25 units (OUS Only)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.