Atlan A350XL. Model Number: 8621600. anesthesia workstation recall (Draeger, Inc.)
Medical deviceClass IOngoing
Summary: Draeger, Inc. is recalling 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.
What is being recalled
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Why
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
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 (states named: Arkansas, Arizona, Colorado, Florida, Massachusetts, Minnesota, North Dakota, New York, Pennsylvania, South Dakota, Wisconsin)
How to tell if yours is affected
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, ASSH-0247, ASSH-0248, ASSH-0249, ASSH-0250, ASSL-0355, ASSL-0356, ASSL-0358, ASSL-0359, ASSL-0361, ASSH-0239, ASSH-0241, ASSH-0244, ASSH-0251, ASSH-0252, ASSH-0253, ASSH-0254, ASTA-0308, ASTA-0310, ASTA-0312, ASTA-0271, ASTA-0272, ASTA-0273, ASTA-0274, ASTA-0275, ASTA-0276, ASTA-0352, ASTA-0354, ASTA-0364, ASTA-0395, ASTA-0396, ASTA-0397, ASTA-0407, ASSM-0464, ASSM-0465, ASSM-0466, ASSM-0467, ASSM-0468, ASSM-0469, ASSM-0491, ASSM-0492, ASSM-0493, ASSM-0494, ASSM-0495.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2208-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | May 7, 2026 |
| Reported | June 10, 2026 |
| Company | Draeger, Inc. |
| Company location | Telford, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 394 units |
More recalls from Draeger, Inc. · all medical device recalls · recalls from May 2026