The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1806-2017·Announced 2017-04-19

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.

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 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.
Category
Medical Device — Therapeutic Wear
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

Same manufacturer · 2k Innovations Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls