Philips Respironics recalled 13,811 ventilators the company reworked or replaced after it pulled millions of them off the market in summer 2021.
The devices — Trilogy 100, Trilogy 200, and Garbin Plus ventilators — were recalled because foam could break away from the plastic backing and block the airpath. Patients can also ingest the foam. Both issues can cause serious injury or death, the FDA said Feb. 16.
As of Jan. 4, 82 medical device reporting complaints were filed. There have been no deaths reported.
Philips has temporarily paused reworking the Trilogy 100 and Trilogy 200 ventilators, according to the FDA.