Volt Resistance Heated Therapy Foot Wrap Recalled for Unapproved Medical Claims
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Therapy Foot Wraps because FDA inspections found unapproved therapy and medical claims on product information and the company website.
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 explicitly states the issue is unapproved claims found during inspection, with no reported injuries or illnesses. This aligns with the 'Moderate' criteria for minor labeling or compliance errors without reported harm.
Plain-English summary
2k Innovations Inc. is recalling 22,757 units of the Volt Resistance Heated Therapy Foot Wrap, Item #VH-FOOT. The product is described as a deep penetrating heat garment and wrap. The items were distributed nationwide.
The recall was initiated after an FDA inspection revealed that the firm makes unapproved therapy and medical claims regarding the product on its product information and website. The source text does not report any specific illnesses, injuries, or deaths associated with the use of this device.
Consumers who purchased this product should stop using it and contact 2k Innovations Inc. for further instructions. The recall is based on regulatory compliance issues regarding marketing claims rather than a reported physical defect or safety hazard.
The recalled product
- Product
- Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
- Manufacturer
- 2k Innovations Inc.
- Hazard
- Affected units
- 22,757
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 (1)
- Item #VH-FOOT
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by 2k Innovations Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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