Z-2137-2016Class II

HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature...

Name: Z-2137-2016 HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature...
Creator: Ergoactives, Llc
Published: 2016-01-19
License: https://open.fda.gov/license/

Ergoactives, LLC / initiated 2016-01-19 / Terminated

FDA source

Ergoactives, Llc began a recall of HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter on 2016-01-19. FDA classified it as Class II and gives the reason as "Products are marketed without a cleared 510k". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2137-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-19
Posted: 2016-07-07
Terminated: 2017-10-13
Recalling firm: Ergoactives, LLC
Product: HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Product code: IRT Pad, Heating, Powered
Reason for recall: Products are marketed without a cleared 510k.
FDA root cause: No Marketing Application
Action: Customers were notified by phone on 01/19/2016. Two follow-up notifications were sent to customers via e-mail. Customers were asked to immediately examine their inventory for the affected product; and, to notify and identify any customers they may have further distributed to. Ergoactives LLC requests that all Heaterbaum products be sent back to their headquarters: 20725 NE 16th Avenue, Suite A-26, Miami, FL 33179, along with the order number and note of where the product was purchased. The enclosed response form should be completed and returned as well. If customers have any questions, they can call Ergoactives LLC at (305)359-5031. Customers will receive a full refund for the return of their Heaterbaum products.
Quantity in commerce: 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.
Product codes and lots: All lots; UPC: 862821000030.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2137-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2137-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

Product code IRT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)