FDA: Class I recall of Teleflex Iso-Gard Filter S

Editor's Note

The Food and Drug Administration (FDA) on November 1 identified the recall of Teleflex’s Iso-Gard Filter S as Class I, the most serious.

Iso-Gard filters are breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in operating rooms and ICUs.

The recall was initiated because of reports that the filters may split or detach from the breathing systems, which may cause a patient to receive insufficient air supply, have a drop in oxygen level, and experience cross-contamination.

There have been 36 complaints, 4 injuries, and no deaths or long-term injuries associated with this issue.

Distribution dates were September 1, 2020, to July 5, 2022.