The FDA posted an alert April 13 over Philips Respironics' website's claim of shipping 2.46 million "new replacement devices and repair kits" after a summer 2021 recall involving millions of respirators, CPAP and BiPAP machines.
Philips Respironics' site says "90 percent of the production of replacement devices and repair kits globally has been completed" and "2,460,000 new replacement devices and repair kits shipped in the US" as of Jan. 25. The FDA said the number of replacement and remediated devices is "considerably less" because the 2.4 million figure "includes manufactured repair kits that Philips shipped internally to their repair facilities," not just customers.
The agency said it is "concerned this may impact the estimated wait time for consumers still awaiting a replacement device" and recommended customers waiting on a replacement device to contact Philips.