FDA MedWatch- Early Alert: Anesthesia Machine Issue from Draeger, Inc.
Published: 05/18/2026
Sources:
- Food and Drug Administration
Relevant To:
- Ambulatory Surgical Centers,
- Rural Emergency Hospitals,
- Critical Access Hospitals,
- Hospitals,
- Long Term Care
The FDA updated its medical device recall listing on 2026-05-18 for Draeger, Inc.’s Atlan A350 and Atlan A350 XL anesthesia workstations, which are associated with a manufacturing error that may cause the piston ventilator to fail before use or mechanical ventilation to fail during use.
Affected Devices:
- Product Names: Atlan A350 and Atlan 350XL anesthesia workstations
- Unique Device Identifier (UDI)/Model:
- Atlan A350: 04048675556176/8621500
- Atlan A350 XL: 04048675556183/86216…