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2k Innovations Inc.

Complete recall history across all FDA and CPSC categories — 12 total recalls

2k Innovations Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (12)

FDA medical device enforcement actions by 2k Innovations Inc.

Date Product Reason Class
Apr 15, 2016 Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and ... During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetra... During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment a... During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garme... During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment an... During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garmen... During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garm... During an FDA inspection it was found that the firm claims unapproved therapy... Class II
Apr 15, 2016 Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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