Compass Health Brands REX recall — FDA Z-1398-2023
Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication
Overview of recall records associated with Compass Health Brands (Corporate Office), including dates, categories and classifications where available.
Classification mix: Class II: 8.
Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication
Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Product design change did not receive proper premarket clearance and lacks a 510 (k)
This page summarizes recall records in which the official source identifies Compass Health Brands (Corporate Office) as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.