Z-1813-2017Class II

Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps

Name: Z-1813-2017 Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
Creator: 2k Innovations Inc.
Published: 2016-04-15
License: https://open.fda.gov/license/

2k Innovations Inc. / initiated 2016-04-15 / Terminated / root cause: labeling and UDI

FDA source

2k Innovations Inc. began a recall of Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps on 2016-04-15. FDA classified it as Class II and gives the reason as "During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1813-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Posted: 2017-04-12
Terminated: 2019-08-07
Recalling firm: 2k Innovations Inc.
Product: Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
Product code: IRT Pad, Heating, Powered
Reason for recall: During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 2k Innovations sent e-mail communication from 04/15/2016 thru 09/09/2016 informing their consignees that the firm is no longer linking their products to any medical and therapeutic claims and that new labels and boxes will be corrected and the claims will be taken out of the website. For questions customers should call 888-518-6871, ext 700.
Quantity in commerce: 22,757 items in total
Distribution: Nationwide Distribution
Product codes and lots: Item #VS-PU

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1813-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1802-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1803-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1804-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1805-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1806-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1807-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1808-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1809-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1810-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1811-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1812-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12
Z-1813-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12

Product code IRT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)