2k Innovations Recalls Volt Heated Elbow Garments for Unapproved Claims
2k Innovations is recalling 22,757 Volt Resistance Heated Elbow Garments because FDA inspections found the firm made unapproved therapy and medical claims.
What this means for you
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 cites unapproved labeling claims rather than physical defects or reported injuries, aligning with the rubric for minor labeling errors.
Plain-English summary
2k Innovations Inc. is recalling 22,757 units of the Volt Resistance Heated Elbow Garment, a deep penetrating heat garment and wrap. The product is identified by Item #VH-ELBOW and was distributed nationwide.
The recall was initiated after an FDA inspection revealed that the firm claimed unapproved therapy and medical benefits on product information and its website. These claims were not authorized by the FDA.
Consumers who purchased this product should stop using it and contact 2k Innovations Inc. for further instructions or a refund.
The recalled product
- Product
- Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
- Manufacturer
- 2k Innovations Inc.
- 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-ELBOW
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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