BMC Medical Selling Adulterated, Misbranded CPAPs: FDA

A 12/1-10/10/2025 FDA inspection at 3B Medical, doing business as Reach Health, in Dublin, OH, established that BMC Medical in Beijing, China, is the specification developer and 510(k) owner of various ventilator devices that are imported into the U.S. A just-released 5/20 Warning Letter says the inspection revealed that the BMC devices are adulterated because the company does not have an approved PMA for them, and are misbranded because BMC introduced the devices into interstate commerce with significant changes or modifications without submitting a new PMA to FDA.

The letter also says BMC failed to submit a required report to FDA within 10 days of initiating a correction or removal of a device.

BMC was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.