Ergoactives, Llc: Medical Device Recall in 2016 - (Recall #: Z-2137-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 19, 2016

Date Posted: July 13, 2016

Recall Number: Z-2137-2016

Event ID: 74078

Reason for Recall:

Products are marketed without a cleared 510k.

Status: Terminated

Product Quantity: 278 units

Code Information:

All lots; UPC: 862821000030.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated