Product Wiki · Recalls · U.S. FDA — Device Enforcement

HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression… — recall Z-2137-2016

U.S. FDA — Device Enforcement · United States · 2016-01-19 · Class II

As described by U.S. FDA — Device Enforcement: HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2137-2016
Date of alert
2016-01-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ergoactives, Llc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
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.
Barcode (EAN/GTIN)
862821000030
Reported risk: Products are marketed without a cleared 510k.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.