HIGHFDA DEVICE

Atlan A350XL. Model Number: 8621600. anesthesia workstation

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

DraegerHealth & Personal CareMedical DevicesModel Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354ASSL-0357ASSL-0360

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
May 7, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 7, 2026
Hazard Level
HIGH
Brand
Draeger
Geographic Scope
Nationwide (50 states)

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Draeger
Model numbers
Model Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354, ASSL-0357, ASSL-0360, ASSH-0240, ASSH-0242, ASSH-0243, ASSH-0245, ASSH-0246 +12 more
Where affected
Nationwide

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 7, 2026

  2. Reported by FDA DEVICE

    June 10, 2026

  3. RecallRadar source check

    June 16, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Draeger, Inc. or your healthcare provider for instructions. Notification method: E-Mail

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Full Description

Atlan A350XL. Model Number: 8621600. anesthesia workstation. Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.. Classification: Class I. Quantity: 394 units. Distribution: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Brand
Model Numbers
Model Number: 8621600. UDI-DI Number: 04048675556183. Serial Numbers: ASSL-0354
ASSL-0357
ASSL-0360
ASSH-0240
ASSH-0242
+15 more
Affected States
Nationwide
Report Date
June 10, 2026
Recall Status
ACTIVE

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