FDA (Devices) recall action 91538
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
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.
Draeger Medical is recalling 893 units of NovaStar TS Standard elbow components due to magnets that could interfere with medical devices and metallic implants.
Draeger Medical recalls NovaStar TS Anti-Asphyxia Valves due to magnets that may interfere with implanted and non-implanted medical devices and metallic implants.