FDA Device recall Z-2137-2016
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC A…
- FDA Device
- Class II
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class II recall of HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC A… by Ergoactives, citing products are marketed without a cleared 510k.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2137-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-19 |
| Published | 2016-07-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ergoactives |
| Distribution | 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 |
Product
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Reason
Products are marketed without a cleared 510k.
Identifiers
| upc | 862821000030 |
|---|---|
| code_info | All lots; UPC: 862821000030. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2137-2016%22
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