Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1809-2017·Announced 2017-04-19

2k Innovations Recalls Volt Heated Socks for Unapproved Medical Claims

2k Innovations is recalling Volt Resistance Heated Socks 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, but the source text explicitly states the issue is unapproved claims found during inspection, with no reported injuries or illnesses. This aligns with the rubric for moderate severity involving labeling or regulatory issues without immediate physical harm.

Plain-English summary

2k Innovations Inc. is recalling Volt Resistance Heated Socks (Item #3V-SK) in all sizes. The recall involves 22,757 items that were distributed nationwide.

The recall was initiated after an FDA inspection revealed that the firm claims unapproved therapy and medical claims on the product information and website. The product is described as a deep penetrating heat garment and wraps.

Consumers who purchased these socks should stop using them for the unapproved medical purposes claimed by the manufacturer. The source text does not specify a specific consumer action such as returning the product or seeking a refund, but the recall is due to regulatory non-compliance regarding labeling and claims.

The recalled product

Product: Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
Manufacturer: 2k Innovations Inc.
Category: Medical Device — Thermal Therapy
Hazard: mis-labeling
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 #3V-SK

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 →

Same manufacturer · 2k Innovations Inc.

See all →

Moderate
Volt Resistance Heated Therapy Foot Wrap Recalled for Unapproved Medical Claims
FDA (Devices) · 2017-04-19
Moderate
2k Innovations Recalls Heated Neck Garments for Unapproved Medical Claims
FDA (Devices) · 2017-04-19
Moderate
FDA Recalls Volt Heated Slippers for Unapproved Medical Claims
FDA (Devices) · 2017-04-19
Moderate
2k Innovations Recalls Volt Resistance Heated Therapy Shoulder Wrap
FDA (Devices) · 2017-04-19
Moderate
FDA Recalls 2k Innovations Heated Lower Back Garment for Unapproved Claims
FDA (Devices) · 2017-04-19

Same hazard · mis labeling