Draeger, Inc.: Gas-machine, Anesthesia
Summary Draeger, Inc. is recalling Atlan A350 anesthesia workstations because the ventilator may either fail to alert users before operation or malfunction during actual use. The affected units were distributed across multiple U.S. states and numerous countries worldwide. This is classified as a Class II recall.
- 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 II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-07
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/de212fdc-e79d-477a-bdaa-37eb796dd452