Philips is recalling 1,088 reworked CPAP and BiPAP machines used for sleep apnea due to the potential for inaccurate or insufficient treatment.
The recalled DreamStations devices have incorrect or duplicate serial numbers, which can cause "therapy to be delivered using the wrong prescription or factory default settings," the FDA said in an April 7 recall notice.
Philips has received 43 complaints over the issue. No deaths or injuries have been reported.
Philips has issued several recalls involving its ventilation devices in recent years. The company recalled about 3.5 million devices in June 2021 after finding their sound-abatement foam could degrade into particles and be ingested by users. In November 2022, the company flagged two additional issues related to reworked devices. Phillips also recalled more than 13,000 Trilogy 100, Trilogy 200, and Garbin Plus ventilators in February due to ongoing issues related to the foam, which the FDA said could cause serious injury or death.