Three Class I Medical Device Recalls Hit Ventilators, Anesthesia Equipment

The FDA classified Draeger Atlan A350 anesthesia workstations as a Class I recall—the most serious designation—due to potential piston ventilator failure that could occur before or during surgery. The agency is instructing healthcare providers to inspect and replace the ventilator motor assembly if necessary.

Days later, the agency issued a Class I recall for Philips Trilogy Evo Platform ventilators affecting four model numbers due to risks from non-pneumatic nebulizer use causing tidal volume discrepancies and potential therapy under-delivery. A third recall covers Phasitron 5 In-Line Valves used in respiratory therapy, where design limitations can cause leaks through the pressure relief valve.

Hospitals and surgical centers relying on these devices face immediate pressure to inspect, update software, or replace equipment. Patients in critical care or undergoing surgery depend on these machines delivering consistent therapeutic output—a failure can be fatal within minutes.