March 10, 2022

The FDA issued a 518(a) notification order to Philips because of the company’s “failure to timely provide effective notice to health professionals who prescribe or use the Recalled Products and other persons (including consignees, distributors, retailers, and device users) who should be notified, of the recall and the health risks presented by the Recalled Products.” Philips was ordered to notify people of the “unreasonable risk of substantial harm to the public health” posed by the foam degradation within the next 45 days. This was the first 518(a) notification order issued by the FDA in the 21st century. Prior to the Philips recall, the agency had not issued a 518(a) notification order since 1995.