Class II — Ergoactives, Llc
| Recalling firm | Ergoactives, LLC |
|---|---|
| Registered facility | ERGOACTIVES, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Products are marketed without a cleared 510k. |
| Product | HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter. |
| 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. |
| Initiated | 2016-01-19 |
| Classified | 2016-07-06 |
| Terminated | 2017-10-13 |
| Recall number | Z-2137-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ergoactives, Llc (Z-2137-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74078/
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