2k Innovations Recalls Volt Heated Socks for Unapproved Medical Claims
2k Innovations is recalling Volt Resistance Heated Socks because FDA inspections found the product makes unapproved therapy and medical claims.
What this means for you
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 rubric for moderate severity involving labeling or regulatory issues without immediate physical harm.
Plain-English summary
2k Innovations Inc. is recalling Volt Resistance Heated Socks (Item #3V-SK) in all sizes. The recall involves 22,757 items that were distributed nationwide.
The recall was initiated after an FDA inspection revealed that the firm claims unapproved therapy and medical claims on the product information and website. The product is described as a deep penetrating heat garment and wraps.
Consumers who purchased these socks should stop using them for the unapproved medical purposes claimed by the manufacturer. The source text does not specify a specific consumer action such as returning the product or seeking a refund, but the recall is due to regulatory non-compliance regarding labeling and claims.
The recalled product
- Product
- Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
- Manufacturer
- 2k Innovations Inc.
- Category
- Medical Device — Thermal Therapy
- 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 #3V-SK
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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