FDA: Class I recall of certain Philips Respironics ventilators

Editor's Note

The Food and Drug Administration (FDA) on February 16 identified the recall by Philips Respironics of certain reworked Trilogy 100, Trilogy 200, and Garbin Plus ventilators as Class I, the most serious.

The recall was initiated because of the potential for silicone foam adhesive failure and residual polyester-based polyurethane (PE-PUR) foam debris.

As of January 4, 2023, there have been 82 Medical Device Reports (63 for foam delamination and 19 for particulate debris contamination) and no deaths.

Distribution dates were March 1, 2022, to September 6, 2022.