FDA says it was unsatisfied with Philips’ handling of recall

There’s yet another wrinkle in the massive recall of Philips’ sleep apnea and respiratory care devices. On Thursday, FDA sharply criticized the Amsterdam, Netherlands-based company’s handling of the recall. This caused shares of Philips to drop by 9.6% last week.

In its update, the agency said it “remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.”

The recalls, which began in 2021, stem from the polyester-based polyurethane (PE-PUR) foam used in the company’s breathing devices to reduce sound and vibration, breaking down.

If this happens, then black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. The alert was based on problems reportedly associated with the PE-PUR foam breakdown that could potentially result in severe injury and may require medical intervention to prevent permanent injury.

FDA said in its update that “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. 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’ FDA believes additional testing is necessary.

The company said in an email, “Following ongoing communications with FDA, Philips Respironics has agreed with FDA’s recommendations to implement additional testing on certain sleep and respiratory care devices to supplement current test data … Philips Respironics is still in discussions with FDA on the details of further testing.” MD+DI