The FDA has posted 21 enforcement recalls from Draeger, Inc. since 2025, including 21 Class I (most serious) recalls. Most recent report: Jun 10, 2026.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
A certain component of affected devices was not delivered within specification and contained impurities.
A certain component of affected devices was not delivered within specification and contained impurities.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Firm name as filed with the FDA: “Draeger, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.