Philips Slow in Replacing Recalled Sleep Devices, Regulator Says

American consumers may be waiting longer than expected for Royal Philips NV to replace sleep apnea devices that were recalled, the US drugs regulator has warned.

The number of replacement and remediated devices sent to consumers in the US is “considerably less” than the 2.46 million new replacement devices listed on Philips’s website, the US Food & Drug Administration said Thursday.

The Dutch company is swapping out thousands of potentially faulty sleep apnea products, one of the biggest such actions in the medical technology industry after deteriorating foam inside the equipment was found to potentially cause cancer.

“We are concerned this may impact the estimated wait time for consumers,” said the FDA in its update. The regulator encouraged consumers to contact the firm for an update on the status of their replacement device.

Shares of Philips are down (April 14) more than 60% since it started recalling its faulty sleep therapy devices in June 2021, leading the company to swap out its chief executive officer and shed about 5% of its workforce to save costs.

The company has made cumulative financial provisions of nearly $1.1 billion for the recall, warning it might need to increase funds set aside as lawsuits progress.

Around 2.2 million products have been shipped, though not all of the replacement devices and repair kits have yet been delivered to patients in the US, according to a Philips spokesman.

Last week a court in Milan upheld a claim against Philips for taking too long to replace faulty sleep apnea devices. The Italian court ordered the company to complete the recall by the end of April or face a daily penalty of €20,000. Philips said it is considering next steps, which may include an appeal.