The FDA has identified a recall for certain reworked Philips Trilogy and Garbin ventilators as Class I, the most serious type of recall, as use of these devices can cause serious injuries or death.

The affected ventilators — Trilogy 100, Trilogy 200 and Garbin Plus — were recalled in June 2021. BiPAP and CPAP machines reworked or replaced because of the June 2021 recall are not affected.

This recall is for two potential issues. The adhesive used to attach the silicone sound abatement foam installed to replace PE-PUR foam may fail and potentially block the airpath. Philips also found some residual PE-PUR sound abatement foam in some reworked ventilators, which poses potential health risks.