2k Innovations Inc.: Medical Device Recall in 2017 - (Recall #: Z-1811-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 15, 2016

Date Posted: April 19, 2017

Recall Number: Z-1811-2017

Event ID: 76787

Reason for Recall:

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

Status: Terminated

Product Quantity: 22,757 items in total

Code Information:

Item #VS-GR

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated