FDA Recalls Volt Heated Knee Wrap for Unapproved Medical Claims
2k Innovations Inc. is recalling Volt Resistance Heated Therapy Knee Wraps because FDA inspections found the product makes 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 and involves unapproved medical claims (labeling issues) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
2k Innovations Inc. is recalling the Volt Resistance Heated Therapy Knee Wrap, a deep penetrating heat garment. The recall involves 22,757 items distributed nationwide under item number VH-KNEE.
The recall was initiated after an FDA inspection revealed that the firm makes unapproved therapy and medical claims on the product information and its website. The agency has classified this as a Class II recall.
Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the item or obtain a refund.
The recalled product
- Product
- Volt Resistance Heated Therapy Knee Wrap 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-KNEE
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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