CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

Volt Resistance Heated Slipper Gray recalled by 2k Innovations

2k Innovations is recalling Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps, distributed nationwide in the US. The recall was initiated on 15 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem #VS-GR

Quantity recalled22,757 items in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1811-2017
FDA event ID: 76787
Recalling firm: 2k Innovations, Saint Augustine, FL
Classification: Class II
Status: Terminated
Recall initiated: 15 Apr 2016
FDA classified: 12 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Masks, Gloves & PPE

Timeline

15 Apr 2016	Recall initiated by company
12 Apr 2017	Classified by FDA	+362 days
19 Apr 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Stores named: Online Retailers

Questions about this recall

Is Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps recalled?

Yes. 2k Innovations recalled Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps on 15 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1811-2017.

Why was it recalled?

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

Which lots are affected?

Item #VS-GR

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from 2k Innovations

All 12

Reported	Class	Recall	Company	Reason	Where
19 Apr 2017Device	CLASS II	Volt Resistance Heated Lower Back Garment Deep penetrating recalled	2k Innovations	Processing Deviation	Nationwide
19 Apr 2017Device	CLASS II	Volt Resistance Heated Therapy Foot Wrap Deep penetrating recalled	2k Innovations	Processing Deviation	Nationwide
19 Apr 2017Device	CLASS II	Volt Resistance Heated Neck Garment Deep penetrating heat recalled	2k Innovations	Processing Deviation	Nationwide
19 Apr 2017Device	CLASS II	Volt Resistance Unisex Rechargeable Heated Slipper recalled	2k Innovations	Processing Deviation	Nationwide
19 Apr 2017Device	CLASS II	Volt Resistance Heated Elbow Garment Deep penetrating heat recalled	2k Innovations	Processing Deviation	Nationwide

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