Philips' Ventilator Device Recall Faces FDA's Continued Discontent Pressure

In its latest update on Koninklijke Philips NV's PHG Respironics' June 2021 recall of certain CPAP, BiPAP, and ventilator devices, the FDA highlights ongoing concerns about the potential health risks from the devices' foam degradation.

Philips has been handling a Class I recall of certain respiratory devices since mid-2021 when its subsidiary Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP), and continuous positive airway pressure (CPAP) machines.

The update from Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, says the FDA "remains unsatisfied" with the recall status and that Philips' testing to date is inadequate. 

"We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices," reads the update. 

"Although Philips concluded that the exposure to foam particles and VOCs from these devices is 'unlikely to result in an appreciable harm to health in patients,' the FDA believes additional testing is necessary. 

Philips agreed to conduct the additional testing requested by the FDA. The agency maintains its recommendations regarding the health risks associated with the PE-PUR foam breakdown at the center of the recall.

In 2021-2022, Philips witnessed a market valuation decline exceeding 66% due to the recall. However, the company has begun to experience a gradual resurgence in 2023.

Price Action: PHG shares are down 10.30% at $17.68 during the premarket session on the last check Friday.