The United States Food and Drug Administration has placed a Class I Recall on several Philips Respironics Recalls BiPAP and CPAP masks. Class I recalls are the most severe type of recall, and the use of the recalled devices, drugs, or food products could cause serious injuries or death. This Philips Respironics BiPAP and CPAP […]
Philips Respironics Mask Lawsuits
The United States Food and Drug Administration has placed a Class I Recall on several Philips Respironics Recalls BiPAP and CPAP masks. Class I recalls are the most severe type of recall, and the use of the recalled devices, drugs, or food products could cause serious injuries or death. This Philips Respironics BiPAP and CPAP mask recall affects more than 18.6 million units.
The recalled Philips Respironics masks include:
The recalled Philips Respironics masks’ serial and model numbers can be found on the FDA’s recall database. The recalled masks were distributed from January 1, 2015, until September 9, 2022. The Amara Full Face, DreamWear Full Face, DreamWisp Nasal, Therapy Mask 3100 NC/SP, and Wisp and Wisp Youth Nasal masks are used by patients who are using continuous positive airway pressure (CPAP) machines or bilevel positive airway pressure (BPAP, Bilevel PAP, or BiPAP) machines to support breathing. The affected masks are single-patient, in-home use or are used in multi-patient clinical environments. The recalled Philips Respironics masks are also used with other manufacturers’ CPAP and BiPAP machines. Users of any CPAP or BiPAP machine should inspect their mask to see determine if their mask is a recalled Philips mask.
Philips Respironics (Philips) has initiated a recall of specific Amara Full Face, DreamWear Full Face, DreamWisp Nasal, Therapy Mask 3100, and Wisp and Wisp Youth Nasal masks due to a dangerous safety concern. According to the FDA’s safety communication, the recalled Philips Respironics masks have magnetic headgear clips that hold the mask in place. The magnets used could cause injury or death if patients who use them, or individuals close to someone using the recalled masks, have metallic, implanted metallic medical devices or other metallic implanted objects.
So far, there have been more than 40 complaints about the recalled masks. Fourteen of these incident reports stated that serious injuries were associated with this problem. The FDA stated that it is not currently aware of any associated deaths.
Phillips Respironics published a media release concerning this issue on September 6, 2022. That press release provided the following recommendations:
The FDA’s safety communication has been issued to patients, healthcare providers, and patient caregivers. Medical professionals and patients may report reactions or problems to MedWatch.
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