Won Industry Co.: Medical Device Recall in 2017 - (Recall #: Z-0205-2018)

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:

Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.

Product Classification:

Class II

Date Initiated: January 13, 2017

Date Posted: December 13, 2017

Recall Number: Z-0205-2018

Event ID: 78182

Reason for Recall:

Distribution of unapproved devices with incorrect air compression level setup

Status: Terminated

Product Quantity: 3

Code Information:

none

Distribution Pattern:

Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico

Voluntary or Mandated:

Voluntary: Firm initiated