Philips Faces Production Restrictions in U.S. After Sleep Apnea Device Recall

A federal court mandates safety overhauls and compensation for affected customers, limiting domestic sales but allowing international distribution.

A U.S. federal court has issued a decree to restrict Philips' production and sale of new sleep apnea devices until safety requirements are met.
The decree follows a recall of over 5 million devices due to concerns that noise-reducing foam could degrade and become toxic.
Philips is required to overhaul its manufacturing and quality control systems and hire independent experts to verify changes.
The company must also provide refunds, repairs, or replacements for U.S. customers and pay part of its revenue to the federal government.
Philips will continue to supply sleep and respiratory care devices outside the U.S. but faces restrictions on domestic sales.