FDA Recalls Volt Heated Slippers for Unapproved Medical Claims
2k Innovations Inc. is recalling Volt Resistance Heated Slippers because FDA inspections found the product makes unapproved therapy and medical claims.
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. The hazard involves unapproved medical claims rather than a physical defect or reported injury, fitting the criteria for moderate severity involving labeling or regulatory non-compliance without reported harm.
Plain-English summary
2k Innovations Inc. is recalling 22,757 units of the Volt Resistance Heated Slipper Black (Item #VS-BK) in all sizes. The product is described as a deep penetrating heat garment and wrap. The recall covers items 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 its website. These claims were not approved by the FDA.
Consumers who purchased these slippers 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, nor does it report any illnesses or injuries associated with the use of the device.
The recalled product
- Product
- Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
- Manufacturer
- 2k Innovations Inc.
- 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 #VS-BK
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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See all →- ModerateVolt Resistance Heated Therapy Foot Wrap Recalled for Unapproved Medical Claims
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