Compass Health Brands (Corporate Office) recalls REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle ac…

Recall date

March 7, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1398-2023

FDA classification

Class II

Brand / firm

Compass Health Brands (Corporate Office)

Sold / distributed

Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L