FDA recall, , High risk
Draeger Atlan A350 and A350XL Anesthesia Workstations
The Atlan A350 anesthesia workstation indicated a failure of the piston ventilator before use or suffered a failure of mechanical ventilation during use.
Summary by Recall Canary from the FDA notice
What happened
Draeger, Inc., of Telford, Pennsylvania, recalled its Atlan A350 and Atlan A350XL anesthesia workstations because 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 recall began May 7, 2026, and was added to the FDA's Enforcement Report on June 4, 2026. The products were distributed in the United States and internationally.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Atlan A350XL.
- Model
- 8621600
- UDI-DI
- 04048675556183
Atlan A350.
- Model
- 8211500
- UDI-DI
- 04048675556176
Recall details
- Company began the recall
- Sold in
US distribution in Wisconsin, Arkansas, Minnesota, Wisconsin, Colorado, Massachusetts, Pennsylvania, Arizona, Florida, New York, South Dakota, North Dakota. 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
- Company
- Draeger, Inc.Telford, Pennsylvania
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98914
- Recall numbers
- Z-2207-2026 to Z-2208-2026
All recalls from Draeger, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
