Draeger, Inc.: Atlan A350xl. Model Number: 8621600. Anesthesia Workstation
Recall Summary Draeger, Inc. is recalling Atlan A350XL anesthesia workstations (Model Number 8621600) because the ventilator may fail to operate properly—either showing a failure warning before use or stopping during actual use. This is a Class I recall affecting units distributed across multiple U.S. states and numerous countries worldwide.
- Recalling firm
- Draeger, Inc.
- Product
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-07
- Status
- Ongoing
- Areas affected
- AZ, AR, CO, FL, MA, MN, NY, ND, PA, SD, WI
- 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,...
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/b2dae62e-396e-4cca-a437-6d92c0d22d4f