CLASS II Device recall · Reported 13 Dec 2017 · FDA Enforcement Report
Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves recalled
Won Industry is recalling Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection, distributed nationwide in the US. The recall was initiated on 13 Jan 2017 and the FDA has classified it as Class II.
Check your package
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-0205-2018
- FDA event ID
- 78182
- Recalling firm
- Won Industry, Siheung-si, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2017
- FDA classified
- 6 Dec 2017
- Reported
- 13 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Temperature Abuse
- Device type
- Heart & Vascular Devices
Timeline
| 13 Jan 2017 | Recall initiated by company | |
| 6 Dec 2017 | Classified by FDA | +327 days |
| 13 Dec 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
Distribution of unapproved devices with incorrect air compression level setup
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
Questions about this recall
Is Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection recalled?
Yes. Won Industry recalled Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection on 13 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-0205-2018.
Why was it recalled?
Distribution of unapproved devices with incorrect air compression level setup
Which lots are affected?
none
Where was it sold?
Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
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.
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Other Heart & Vascular Devices recalls
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |