FDAClass IIJuly 13, 2016

HeaterBaum Foot & Ankle Heating Pad recall

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

Why was HeaterBaum Foot & Ankle Heating Pad recalled?

Products are marketed without a cleared 510k.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots; UPC: 862821000030.

Product
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Recalling firm
Ergoactives, Llc
Quantity
278 units
Distribution
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.
Recall date
July 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls