FDA (Devices) recall action 76787
The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Therapy Foot Wraps because FDA inspections found unapproved therapy and medical claims on product information and the company website.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Neck Garments because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.
2k Innovations Inc. is recalling Volt Resistance Heated Slippers because the firm made unapproved therapy and medical claims on product information and its website.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Therapy Shoulder Wraps because the firm made unapproved therapy and medical claims on product information and its website.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Lower Back Garments because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.
2k Innovations Inc. is recalling Volt Resistance Heated Slippers because FDA inspections found the product makes unapproved therapy and medical 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.
2k Innovations Inc. is recalling Volt Resistance Heated Therapy Knee Wraps because FDA inspections found the product makes unapproved therapy and medical claims.
2k Innovations is recalling Volt Resistance Heated Slippers because FDA inspections found the company made unapproved therapy and medical claims on product information and its website.
2k Innovations Inc. is recalling Volt Resistance Unisex Rechargeable Heated Slippers because FDA inspections found the company made unapproved therapy and medical claims.
2k Innovations is recalling Volt Resistance Heated Socks because FDA inspections found the product makes unapproved therapy and medical claims.
2k Innovations is recalling 22,757 Volt Resistance Heated Elbow Garments because FDA inspections found the firm made unapproved therapy and medical claims.