FDA Recalls Heated Slippers for Unapproved Medical Claims
2k Innovations Inc. is recalling Volt Resistance Unisex Rechargeable Heated Slippers because FDA inspections found the company made 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, which typically corresponds to a moderate severity level. The hazard involves regulatory non-compliance regarding unapproved claims rather than a direct physical safety defect or reported injury.
Plain-English summary
2k Innovations Inc. is recalling the Volt Resistance Unisex Rechargeable Heated Slipper (Item #VS-PU) 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 product information and its website. The product is described as a deep penetrating heat garment and wraps.
Consumers who purchased these slippers should stop using them and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Volt Resistance Unisex Rechargeable Heated Slipper (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 #VS-PU
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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