2k Innovations Recalls Heated Neck Garments for Unapproved Medical Claims
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Neck Garments because FDA inspections found the firm 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. The hazard involves unapproved medical claims (mis-labeling/marketing) rather than a physical defect causing injury, and no illnesses or injuries are reported, fitting the 'Moderate' criteria for labeling errors and voluntary precautionary actions.
Plain-English summary
2k Innovations Inc. is voluntarily recalling 22,757 units of the Volt Resistance Heated Neck Garment (Item #VH-NECK). The product is described as a deep penetrating heat garment and wrap. The recall was initiated after an FDA inspection identified that the firm was making unapproved therapy and medical claims regarding the product on its product information and website.
The recalled items were distributed nationwide. The source text does not specify specific states, retailers, or distribution dates. No illnesses, injuries, or deaths are reported in the source text.
Consumers who possess this product should stop using it and contact 2k Innovations Inc. for instructions on how to return the item or obtain a refund. The recall is driven by regulatory non-compliance regarding marketing claims rather than a reported physical defect or safety hazard in the device itself.
The recalled product
- Product
- Volt Resistance Heated Neck Garment 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 #VH-NECK
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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- ModerateFDA Recalls 2k Innovations Heated Lower Back Garment for Unapproved Claims
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FDA (Devices) · 2017-04-19
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