In a Class I recall, the most serious type, devicemaker Teleflex recalled 60,500 bacterial filters in response to four injuries and 36 complaints of the filter separating from breathing systems.
Teleflex's Iso-Gard Filter S filters connect to respiratory devices used in ICUs and operating rooms to protect patients from airborne contaminants, according to the FDA. If the filters split or detach, the risks include cross-contamination and a patient's oxygen levels falling below safe levels.
As of Nov. 2, the FDA had received zero reports of deaths or long-term injuries related to the recall.