FDA Medical Device Recalls (openFDA)
Ergoactives, Llc: HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
- Recall number
- Z-2137-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-01-19
- Posted
- not on file
- Terminated
- 2017-10-13
- Reason
- Products are marketed without a cleared 510k.
- 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
- 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.
- Lot, serial or model codes
- All lots; UPC: 862821000030.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IRT
- Firm FEI
- 3007084179
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28