Draeger, Inc.: Atlan A350. Model Number: 8211500. Anesthesia Workstation
Draeger, Inc. is recalling Atlan A350 anesthesia workstations (Model Number: 8211500) because the ventilator may either fail to indicate a problem before use or fail during mechanical ventilation. The recall affects units distributed across multiple U.S. states and numerous countries worldwide. This is classified as a Class I recall, the most serious category.
- Recalling firm
- Draeger, Inc.
- Product
- Atlan A350. Model Number: 8211500. 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/3f2435e7-c01f-44fa-9743-dfa7a1a4072f