The Recall Desk

FDA (Devices) recall action 78182

Won Industry Co. recalled 2 products on 2017-12-13

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2017-12-13
Critical
0
Units
5

Why these products were recalled

Distribution of unapproved devices with incorrect air compression level setup

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2017-12-13

    FDA Recalls Two Unapproved Morning Life Air Compression Devices

    Won Industry Co. is recalling two Morning Life air compression devices because they were distributed without FDA approval and have incorrect air compression settings.

    Product
    Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 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
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2017-12-13

    FDA Recalls Unapproved Compressible Limb Therapy Systems Due to Incorrect Air Compression

    Won Industry Co. is recalling three unapproved Compressible Limb Therapy Systems because they have incorrect air compression level setups. The devices were distributed in Maryland, Texas, and Mexico.

    Product
    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 pro
    Category
    Distribution
    2 states