2k Innovations Recalls Volt Resistance Frostie Heated Gloves for Unapproved Claims
2k Innovations Inc. is recalling Volt Resistance Frostie Heated Gloves 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 and involves unapproved medical claims (mis-labeling) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
2k Innovations Inc. is recalling Volt Resistance Frostie Heated Gloves (Item #GL-7V-FR) 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 product information and its website. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these gloves.
Consumers who have purchased these gloves should stop using them and contact 2k Innovations Inc. for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
- Manufacturer
- 2k Innovations Inc.
- Category
- Medical Device — Heated Gloves
- 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 #GL-7V-FR
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 →- ModerateVolt Resistance Heated Therapy Foot Wrap Recalled for Unapproved Medical Claims
FDA (Devices) · 2017-04-19
- Moderate2k Innovations Recalls Heated Neck Garments for Unapproved Medical Claims
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- ModerateFDA Recalls Volt Heated Slippers for Unapproved Medical Claims
FDA (Devices) · 2017-04-19
- Moderate2k Innovations Recalls Volt Resistance Heated Therapy Shoulder Wrap
FDA (Devices) · 2017-04-19
- ModerateFDA Recalls 2k Innovations Heated Lower Back Garment for Unapproved Claims
FDA (Devices) · 2017-04-19
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