FDA Criticizes Insufficient Recall of Philips Sleep Device, Impacting Philips Shares

Shares of Dutch health tech company Philips plummeted to the bottom of the European benchmark on Friday due to the U.S. drug regulator’s criticism of its handling of a significant product recall.

The Amsterdam-listed stock was trading more than 8% lower at 1:15 p.m. London time. It had initially dropped by as much as 10% before partially recovering.

This development presents another setback for Philips following the recall of millions of ventilators used to treat sleep apnea, which CEO Roy Jakobs had previously acknowledged as the company’s “highest priority.”

The U.S. Food and Drug Administration (FDA) expressed its dissatisfaction with Philips’ testing and analysis of the recalled devices, stating that it is insufficient to fully evaluate the risks posed to users. The FDA emphasized the need for additional testing, to which Philips has agreed.

Responding to the FDA, Philips reiterated its commitment to patient health and well-being. The company stated that it is focused on providing replacement devices and undergoing further testing to ensure the safety of the sleep and respiratory care devices involved in the recall.

Philips also highlighted its shared objective with the FDA and other regulators to maintain the highest standards of patient safety and quality in healthcare delivery.