HeaterBaum Foot & Ankle Heating Pad — Class II medical device recall Z-2137-2016
Terminated recall by Ergoactives, Llc, reported 2016-07-13, distributed in AL, AR, CA, FL, GA, KS, MA, MD…. Products are marketed without a cleared 510k.
| Recall number | Z-2137-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ergoactives, Llc, Miami, FL, United States |
| Recall initiated | 2016-01-19 |
| Classified | 2016-07-06 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-10-13 |
| Distributed | 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, WA |
| Countries outside the US | EC, VE |
| Quantity | 278 units |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00862821000030 |
Product
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Reason for recall
Products are marketed without a cleared 510k.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2137-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.