FDA (Devices) recall action 90705
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.
Philips Respironics is recalling 930,813 DreamWisp Nasal Masks worldwide due to missing warnings about magnetic components that could interfere with implantable medical devices or cause metallic splinters.
Philips Respironics Amara View Full-Face Mask lacks critical safety warnings about magnetic components for patients with implantable medical devices. The Class I recall affects 5.6 million units worldwide.
Philips Respironics is recalling DreamWear Full Face CPAP masks due to missing warnings about magnetic components that may pose risks to patients with implantable devices or metallic eye splinters.
Philips Respironics is recalling the Therapy Mask 3100 NC/SP because the product lacks warnings about magnetic components that may affect patients with implantable devices or metallic splinters in the eyes.