FDA (Devices) recall action 82629
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
The agency’s own wording, quoted from the enforcement report.
Compass Health Brands is recalling MediPress pneumatic compression systems because a product design change lacked proper FDA premarket clearance.
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Compass Health Brands is recalling the MediPress pneumatic compression system because a design change lacked proper FDA premarket clearance.
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.