FDA Recalls 2k Innovations Heated Lower Back Garment for Unapproved Claims
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Lower Back 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, but the source text explicitly states the issue is unapproved claims without reporting any illnesses or injuries. Per the rubric, this aligns with a score of 2 for minor labeling or regulatory errors without reported harm.
Plain-English summary
2k Innovations Inc. is recalling 22,757 units of the Volt Resistance Heated Lower Back Garment, Item #VH-BACK. The product was 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 source text does not report any illnesses, injuries, or deaths associated with the use of the product.
Consumers who have purchased this product should stop using it and contact 2k Innovations Inc. for instructions on how to return the item or obtain a refund, as directed by the recalling firm.
The recalled product
- Product
- Volt Resistance Heated Lower Back Garment 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 #VH-BACK
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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