2k Innovations Recalls Volt Heated Slippers for Unapproved Medical Claims
2k Innovations is recalling Volt Resistance Heated Slippers because FDA inspections found the company made unapproved therapy and medical claims on product information and its 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 rather than a physical defect or contamination, and no injuries are reported. This aligns with the 'Moderate' criteria for labeling errors and voluntary precautionary recalls.
Plain-English summary
2k Innovations Inc. is voluntarily recalling 22,757 units of Volt Resistance Heated Slipper Gray (Item #VS-GR) in all sizes. The product is described as a deep penetrating heat garment and wrap. The recall was initiated after an FDA inspection determined that the firm claimed unapproved therapy and medical benefits on product information and its website.
The recalled slippers were distributed nationwide. The hazard associated with this recall is regulatory, involving the promotion of unapproved medical claims rather than a physical defect or contamination in the product itself. No injuries or illnesses have been reported in connection with this recall.
Consumers who purchased these slippers should stop using them for the unapproved medical purposes claimed by the manufacturer. They should contact 2k Innovations Inc. for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Volt Resistance Heated Slipper Gray (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-GR
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
Same manufacturer · 2k Innovations Inc.
See all →- ModerateVolt Resistance Heated Therapy Foot Wrap Recalled for Unapproved Medical Claims
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- ModerateFDA Recalls 2k Innovations Heated Lower Back Garment for Unapproved Claims
FDA (Devices) · 2017-04-19
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