Ergoactives Recalls HeaterBaum Foot and Ankle Heating Pads
Ergoactives is recalling 278 HeaterBaum Foot & Ankle Heating Pads because they were marketed without a cleared 510(k).
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a lack of 510(k) clearance (a regulatory/documentation issue) rather than a physical defect causing injury. Per the rubric, documentation issues and minor labeling/regulatory errors fall under Moderate severity.
Plain-English summary
Ergoactives, Llc is recalling 278 units of the HeaterBaum Foot & Ankle Heating Pad, a heating soft compression therapeutic boot with precise temperature control thermostat. The product operates at 110 V with an AC adapter.
The recall was initiated because the products were marketed without a cleared 510(k). This is a regulatory compliance issue regarding the marketing authorization of the medical device.
The affected units were distributed worldwide, including in the United States (specifically in 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 in the countries of Ecuador and Venezuela. The recall covers all lots with UPC 862821000030. Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
- Manufacturer
- Ergoactives, Llc
- Affected units
- 278
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots
- UPC: 862821000030.
Distribution
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