Compressible Limb Therapy System — Class II medical device recall Z-0205-2018
Terminated recall by Won Industry Co., reported 2017-12-13, distributed nationwide. Distribution of unapproved devices with incorrect air compression level setup
| Recall number | Z-0205-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Won Industry Co., Siheung-si, N/A, Korea (the Republic of) |
| Recall initiated | 2017-01-13 |
| Classified | 2017-12-06 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2023-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 3 |
| Reason classes | unapproved product |
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 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.
Reason for recall
Distribution of unapproved devices with incorrect air compression level setup
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0205-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.