Ergoactives, Llc recalls HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermos…

Recall date

January 19, 2016

Source

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

Recall number

Z-2137-2016

FDA classification

Class II

Brand / firm

Ergoactives, Llc

Sold / distributed

Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WA; and, the countries of Ecuador & Venezuela.

Why it was recalled

Products are marketed without a cleared 510k.

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

What was recalled

HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.